AS9100 Quality Manual

St. Vrain Manufacturing, Inc.

SAE AS9100

QMQM- 001

Quali ual i t y Management Management System yst em Manual Manual

Quality Manual Revision: C Date: at e: 09/ 23/ 06 This document document expires one day aft er print pri nting ing

Page: age: 1 of 44 Las Last Print ri nted: ed: 7/ 9/ 2009 2009


SAE AS9100

QMQM- 001


Document Cont ontrol rol Revision Hist Hist ory Page All 3-4 24

Reason eason f or Change New Document ocument Updatt e Table of Cont Upda ontent ents s Delet e secti on 2.2 on government government doc’ s

Rev. A B C

Revision Approval Signat ignat ure:

Revision: C Date: at e: 09/ 23/ 06 This document document expires one day aft er print pri nting ing

Reviewer evi ewer R. Ryer R. Ryer R. Ryer

Releas el ease e Date at e 05/ 05/ 23/ 23/ 05 08/ 22/ 06 09/ 09/ 23/ 23/ 06

Date: 09/ 09/ 23/ 23/ 06



SAE AS9100

QMQM- 001


Document Cont ontrol rol Revision Hist Hist ory Page All 3-4 24

Reason eason f or Change New Document ocument Updatt e Table of Cont Upda ontent ents s Delet e secti on 2.2 on government government doc’ s

Rev. A B C

Revision Approval Signat ignat ure:


Reviewer evi ewer R. Ryer R. Ryer R. Ryer

Releas el ease e Date at e 05/ 05/ 23/ 23/ 05 08/ 22/ 06 09/ 09/ 23/ 23/ 06

Date: 09/ 09/ 23/ 23/ 06



SAE AS9100

QMQM- 001


Contents Topic

Page

1 1.1 1.2 1.3 1.4 1.5 1.6 1.7

Introduction 6 Purpos urpose e of St. Vrain rain Manufac nufacturing turing,, Inco Incorpo rpora ratt ed ... ... ... ... ... ... ... ... ... ... ... ... ..6 Scope cope of this Docume cumen nt .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... ..6 Quality Policy licy ............ ........... ........... ............ ........... ........... ............ ..6 Quality Objective bjectives s.... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .6 Custom ustome er Focus...... cus...... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... ..7 Orga rganiza ization Chart .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... 7 Produ roduct ct Realization lization Proce roces ss... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... ..8

2 2.1 2.2 2.3 2.4 2.5

Refer ence Document s 25 ISO Docum ocumen entt s and Stan tanda dards rds... ... ... ... ... ... ... ... ... ... ... .. ... ... ... ... ... .. ... ... ... ... ..25 Governm vernmen entt Docum ocumen entt s and Stan tanda dards rds ... ... ... ... ... ... .. ... ... ... ... ... .. ... ... ... ... ..25 St. Vrain Manufac nufacturing turing - Primary rimary Proced rocedure ures s ... ... ... ... ... ... ... ... ... .. ... ... ... ... ..25 Othe therr Docume cumen nts.. .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... 25 Order rder of Prece recede denc nce...... e...... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... 25

3

Glossary

4 4.1 4.2 4.2.1 .2.1 4.2.2 4.2.3 4.2.4 4.3

Quali t y Management anagement System 25 General ral Require quireme men nts.... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... 25 Docume cumen nted Requ equireme iremen nts... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... ...26 General ral .......... ............ ........... ........... ............ ........... ........... ............ 26 Qu Quality Manua nual .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .26 Control of Docume cumen nts.... ts.... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .27 Control of Quality Records cords.... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... ...27 Configu figuration ration Manageme men nt .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... ..27

5 5.1 5.2 5.3 5.4 5.4.1 5.4.2 5.5 5.5.1 5.5.2 5.5.3 5.6 5.6.1 .6.1 5.6.2 .6.2 5.6.3 .6.3

Management anagement Responsibi esponsibi li t y 28 Manageme men nt Comm mmitme itment nt .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... ...28 Custom ustome er Focus...... cus...... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... ..28 Quality Policy licy ............ ........... ........... ............ ........... ........... ............ ..28 ..28 Planning.........................................................................................28 Quality Objective bjectives s.... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .28 Qualit ualit y Manag nagem emen entt Syst yst em Plannin lanning.. g.. ... ... ... ... ... ... .. ... ... ... ... ... .. ... ... ... ... ..29 Respo espons nsibilit ibilit y, Authorit uthorit y and Com ommu munic nica at ion ... ... ... ... ... ... ... ... ... .. ... ... ... ... ..29 Respons ponsibility ibility and Autho thority.... rity.... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .29 Manag anagem emen entt Repres epresen entt ative, Qualit ualit y Manag anager er .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 29 Intern Interna al Comm mmu unica nication.... tion.... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... ..29 Manag nagem eme ent Review view .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... ..30 General ral .......... ............ ........... ........... ............ ........... ........... ............ 30 Review iew Input put ........... ........... ............ ........... ........... ............ ........... ....3 ....30 0 Review iew Outpu tputt ........... ........... ........... ............ ........... ........... ............ ..30 ..30


25



6 6.1 6.2 6.2.1 .2.1 6.2.2 6.3 6.4

SAE AS9100

QMQM- 001


Resource esour ce Management 30 Provis rovisio ion ns of Resources rces.... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... ...30 Hum uma an Resources rces.... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... ..30 General ral .......... ............ ........... ........... ............ ........... ........... ............ 30 Com ompe petenc tence, e, Awa waren renes ess s and Trainin raining.... g.... ... ... ... ... ... ... ... ... ... ... ... .. ... ... ... ... ..31 Infra Infras structure tructure ............ ........... ........... ............ ........... ........... ............ ..31 ..31 Work Environ vironme ment.. nt.. .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... ...31

7 Product Realizat ion 31 7.1 Plan lanning of Produ roduct ct Realiza ealization tion .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... 31 7.2 Custome ustomerr Related elated Proces rocess ses... es... ... ... ... ... .. ... ... ... ... ... .. ... ... ... ... ... .. ... ... ... ... ..32 7.2.1 Determinat eterminat ion of Requirem equiremen entt s Relat elat ed t o t he Produc roductt .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .32 7.2.2 Review eview of Require equireme ments nts related related to the Produc roduct. t. ... ... ... ... ... ... ... ... .. ... ... ... ... ..32 7.2.3 Custom tome er Comm mmu unication ication.... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... 32 7.3 Design ign and Develo velopm pmen entt .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .33 7.3.1 Desig esign n and Develo evelopm pmen entt Plannin lanning g ... ... ... ... ... ... ... ... .. ... ... ... ... ... .. ... ... ... ... ..33 7.3.2 Desig esign n and Develo evelopm pmen entt Inpu Inputs ts ... ... ... ... ... ... ... ... ... .. ... ... ... ... ... .. ... ... ... ... ..33 7.3.3 Desig esign n and Develo evelopm pmen entt Outputs utputs ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. ... ... ... ... ..33 7.3.4 Desig esign n and Develo evelopm pmen entt Review eview ... ... ... .. ... ... ... ... ... .. ... ... ... ... ... .. ... ... ... ... ..33 7.3.5 Desig esign n and Develo evelopm pmen entt Verificati erificati on ... .. ... ... ... ... ... .. ... ... ... ... ... .. ... ... ... ... ..33 7.3.6 Desig esign n and Develo evelopm pmen entt Validati lidati on ... ... ... ... ... ... ... ... ... ... ... ... ... .. ... ... ... ... ..33 7.3.6.1 7.3.6. 1 Docume Document ntati ati on of Des Design ign and and// or Developmen Developmentt Veri Veri f icat ion and Validati ali dati on.. on.. .. .. .. 33 7.3.6.2 Des Design ign and/ and/ or Developme evelopment nt Verif Verif icati on and and Validati on Tes Test ing.. .. .. .. .. .. .. .. .. .. .33 7.3.7 Cont ont rol of Design esign and and Develop evelopme ment nt Chang hanges es.. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .33 7.4 Purchasing......................................................................................33 7.4.1 Purch urcha asing ing Proce roces ss.. .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... ..33 7.4.2 Purch urcha asing ing Inform Informa ation...... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .34 7.4.3 Verificati erificati on of Purcha urchas sed Produc roductt ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. ... ... ... ... ..34 7.5 Produc roducti ti on and Service ervice Provis rovision.... ion.... ... ... ... ... ... ... ... ... ... ... ... ... ... .. ... ... ... ... ..35 7.5.1 Cont ont rol of Produc roductt ion and and Service ervice Provis rovision ion.. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 35 7.5.1 .5.1.1 .1 Pro Produ ductio ction n Do Docume cumenta ntation tion .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... ..36 7.5.1 .5.1.2 .2 Contr ontr ol of Produc roducti ti on Proc Proces ess s Cha Chang nges es... ... ... ... ... ... ... ... ... ... ... ... ... .. ... ... ... ... ..36 7.5.1.3 Control of Production Equipment, Tools and Numerical Control (NC) Machine Programs........................................................................................36 7.5. 1.4 Cont rol of Work Work Trans Tr ansff erred, err ed, on a Temporary Bas Basis, is, Outside St . Vrain Vrai n Manufac nufacturin turing g’ s Facility..... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .36 7.5.1 .5.1.5 .5 Contr ontr ol of Service ervice Operation perations.... s.... ... ... ... .. ... ... ... ... ... .. ... ... ... ... ... .. ... ... ... ... ..36 7.5.2 Validati on of Process rocesses for Produ Product ction ion and and Service Provision rovision.. .. .. .. .. .. .. .. .. .. .. .. .. .36 7.5.3 Ide Identif ication ication and Trace racea ability....... .... .... .... .... .... .... .... .... .... .... .... .... .... ...37 7.5.4 Custom tome er Prope roperty rty .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... 37 7.5.5 Pres reservation rvation of Produ roduct ct .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... ..38 7.6 Cont ont rol of Monit onit oring and and Meas easuring Devices. evices. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .38




SAE AS9100

QM-001

Qualit y Management System Manual

8 8.1 8.2 8.2.1 8.2.2 8.2.3 8.2.4 8.2.4.1 8.2.4.2 8.3 8.4 8.5 8.5.1 8.5.2 8.5.3

Measurement, Analysis and Improvement 39 General .......... ............ ........... ........... ............ ........... ........... ............ 39 Monitoring and Measurement .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... 39 Customer Satisfaction .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... 39 Internal Audit ............ ........... ........... ............ ........... ........... ............ ..39 Monit oring and Measurement of Processes ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ..40 Monit oring and Measurement of Product .. ... ... ... ... ... .. ... ... ... ... ... .. ... ... ... ... ..40 Inspection Documentation. .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... ..41 First Article Inspection .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... ...41 Contr ol of Nonconforming Product ... ... ... ... ... ... ... ... .. ... ... ... ... ... .. ... ... ... ... ..41 Analysis of Data.. .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... ..42 Improvement ........... ........... ............ ........... ........... ............ ........... ....42 Continual Improvement .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... ..42 Corrective Action.... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... ..42 Preventive Action ........... ........... ........... ............ ........... ........... ..........43

9

Relat ed Level One Document s

44

10

Document Maint enance

44

Revision: C Date: 09/ 23/ 06 This document expires one day aft er printing

Page: 5 of 44 Last Printed: 7/ 9/ 2009


SAE AS9100

1

Introduction

1.1

Purpose of St . Vrain Manufacturing, Incorporated

QM-001


St . Vrain Manufacturing, Incorporat ed, is a product and service providing organization. We offer compressed delivery on manufacturing of high precision, machined parts, made from metals and other exotic materials. 1.2

Scope of t his Document

This document establishes company policy, process requirements and operational procedures for t he St . Vrain Manufacturing quali t y management syst em. This quali t y management syst em is prepared, implement ed and maint ained in accordance wit h the requirements of ISO 9001:2000, with the exclusion of the design element. 1.3

Qualit y Policy

St . Vr ain Manufact uri ng is the leader i n indust ry by pr ovidi ng high accuracy, compressed deli very , pr ot ot ype and R&D, CNC and wi r e EDM machining. St . Vrai n Manuf acturi ng is commit t ed to t he qualit y management syst em, wi ll comply wit h it s requirement s and conti nuall y i mprove system eff ect iveness in meeti ng cust omer expect at ions. St . Vrai n Manuf actur ing believes cust omer sat isfact ion is dir ect ly r elat ed to sat isfyi ng all design requirement s, on ti me deliver y, document at ion and pricing. These it ems are measurable and dat a i s used t o impr ove t he quali t y pr ocess. Every employee underst ands t hat t hey ar e dir ect ly r esponsibl e for qualit y and cust omer sat isfact ion. Employees use the qualit y management system daily as t hey perf orm t heir assigned f unct ions. This quali t y policy is reviewed regularl y t o ensure conti nued suit abil it y of t he St . Vrai n Manuf actur ing qualit y management system t o provi de cust omer sati sf acti on by meeti ng and exceeding our customer's expectations. 1.4

Qualit y Obj ecti ves

Obj ectives for t he quali t y management syst em have been communicated t hrough t he president of St . Vrain Manufacturing. These measurable quali t y object ives include: •

• • • • • • • •

all personnel are committed to understand and comply with the established policies, requirement s and procedures ref erenced in this document , as applicable t o their areas of responsibil it ies on time deli very at 95%or bett er customer returns of nonconforming material less than 2% critical suppliers will be approved, 100% int ernal scrap wil l be less t han 2%of t otal producti on all production processes will exceed a process capability of 1.0 when measured as Cpk measuring processes wil l be evaluat ed to ensure capabil it y is bett er t han 75% all critical measuring equipment will be maintained on an established calibration cycle correct ive and preventi ve acti ons wil l be addressed wit hin 5 worki ng days and resolved within 10 working days, longer, if the situation requires additional time, as agreed upon by all parties involved




1.5

SAE AS9100

QM-001


Customer Focus

The St. Vrain Manufacturing vision is to be our customer's preferred "Supplier-of-Choice" by st ri ving t o be the best at what we do. St . Vrain Manufacturing will build and maintain a relati onship wit h our suppliers and cust omers t o ensure t hat quali t y is never compromised. 1.6

Organizati on Chart President Bob Bergst rom

Office Manager Jan Cook

Office Assistant Corinne Bergst rom

Office Assistant Susan Bergstrom

Operations Manager Dave Lindsay

Shop Manager Tim Henker

Shipping/ Receiving Manager Charl ene St ough

Quality Technician Designer St eve Prucha

Bead Blaster Bernadette Eagle

Bob Inskeep Quality Technician

Part Time Assistant Jennifer Liendo

Machinists Crai g Keeton John Cook

Office Assistant Anne Hansen

Qualit y Manager Rich Ryer

Chri st y Henker Jay Hunter

Process Planning Mark Layt on

Eric McChesney James Herring Matt Diesing Dennis Burt on Jason Grell Gino Parzanici Bruce Layton Ken Huffman Joe Wade




1.7

SAE AS9100

QM-001


Product Realizat ion Process

Out side Sales Process, QMS 8 Quality Documents and Records QMS Processes

Business plan Core competency Cust omer l ist

Customer Requirements Ident if y market demands (Current and Fut ure)

Information Flow Management Responsibility Develop business plan Identif y core competency Survey our competi t ion Develop our customer base

Resource Management Schedul e sales manager t ime Order sales materials Develop web sit e Schedule cust omer appoint ments

Training, as required, t o maint ain process

Customer Feedback

Measurement, Analysis and Improvement Survey cust omer and det ermine level of sati sfact ion. Improve outside sales process with corrective and prevent ive acti ons as required.

Product Realization

Inputs Customer requirements

Sales Mat eri als Web Sit e

Customer not interested. Process st ops.

Customer Feedback

Cust omer cont act Distri bute adverti sing mat erials Publicize t he web sit e Cust omer visit ati on Develop part nerships

Product Out put Sales call wi t h cust omer t o inf orm and develop business part nership

Preventive Action Correcti ve Action Nonconfor ming Materi al Measure and Verify

Information Flow

Customer Sati sfact ion Cust omer want s to do business. Cust omer is not i nt erested.

Cust omer is int erest ed in creati ng a business rel ati onship wi t h St . Vrain Manufacturing and submits a request f or quot e. (See Quoti ng, next page).




1.7

SAE AS9100

QM-001


Product Realization Process

Quot ing Pr ocess, QMS 8 Quality Documents and Records QMS Processes

RFQ f older wi t h cust omer specifications

Customer Requirements Request for quote received from cust omer

Information Flow Management Responsibili t y Review request for quote Determine if quote f it s the business plan. Forward t o appropriate personnel for analysis and recommendations

Resource Management Resources required may include: Specif icat ion Review, Programming, Purchasing, Production, Inspection, Assembly and Shipping


Customer Feedback

Measurement, Analysis and Improvement Survey cust omer and det ermine level of sati sfact ion. Compare to previous quot ing eff orts. Improve quoting process with corrective and preventi ve acti ons as requir ed.

Product Realization


Quote to customer quote folder. Folder fil ed in quote files.

Quot e is a no bid/ rej ected. Process stops.

Customer Feedback

Finished quote may include: Cost, Mat eri als, Machines, Processes, Quanti t ies, and Lead Times. Quote may also be a no bid.

Product Out put Sales call wi t h cust omer t o inf orm and develop business part nership


Information Flow

Customer Sati sfact ion Cust omer accept s quot e Cust omer rej ects quot e Cust omer request s modif icat ions

Cust omer accept s quote and submit s purchase order . (See Purchase Order , next page).




1.7

SAE AS9100

QM-001



Purchase Order Process, QMS 8 Quality Documents and Records QMS Processes

Customer Purchase Order Cust omer Specif icat ions Electr onic Files

Customer Requirements Customer submit s a purchase order t o St . Vrain Manufact uring off ering t o pur chase services.

Management Responsibility Review purchase order. Det ermi ne if purchase order mat ches t he St . Vrain quote of fered t o cust omer.

Resource Management Purchasing revi ews cust omer purchase order f or quantit y, purchase pri ce and specif icat ions. QA revi ews qualit y clauses as appropriate.

Information Flow


Customer Feedback

Measurement, Analysis and Improvement Inform customer on how purchase order met our process requir ements. Improve purchase order process wit h corr ect ive and preventive actions as required.

Product Realization

Inputs

Purchase order is accept ed as is or additional information is requested, as appropriate.

Customer requirements

Customer purchase order filed in purchase order files

Product Out put Final purchase order is delivered to St . Vrain. Job fol der created.


Information Flow

Customer Sati sfact ion Purchase order rej ect ed. Process st ops.

Customer Feedback

St . Vrain r ej ects purchase order St . Vrain accepts purchase order St . Vrain request s modif icat ions and/ or clarif ications

St . Vrai n accepts purchase order f rom customer (See Purchasing, next page).




1.7

SAE AS9100

QM-001



Purchasing Process, QMS 8 Quality Documents and Records QMS Processes

St , Vrain Purchase Order s Cust omer Specif icat ions Electr onic Files

Customer Requirements Cust omer purchase order i s accept ed as a cont ract request ing services off ered by St . Vrain.

Information Flow Management Responsibility Assigned personnel coordi nat e procurement of raw materials required for customer product based on purchase order and customer re uirements.

Resource Management Assigned personnel l ocat e, purchases and schedules deliveries of raw material, hardware, tooling, inspect ion gauging and packaging for cust omer product.


Customer Feedback

Measurement, Analysis and Improvement Compare result s of current ef fort s t o previous eff ort s. Improve purchasing process wit h correct ive and preventi ve acti ons as requir ed.

Product Realization


Purchase order t o supplier: specs, quantity, price and delivery

Required materials for customer product are ordered and scheduled t o be delivered t o St . Vrain in t he correct quantity, at the agreed upon price and on time.

Product Out put Raw mat erials will be available t o production, inspection, assembly and shipping as required.


Information Flow

Customer Sati sfact ion Supplier cannot meet needs. Process stops.

Customer Feedback

Production, quality, assembly and shippi ng personnel have correct materials available when needed.

Suppli er and St . Vrain agree there are no problems. Product ion get s j ob f older (See Programming, next page).




1.7

SAE AS9100

QM-001



Programming Process, QMS 8 Quality Documents and Records QMS Processes

Hard Copy Specif icat ions Electr onic Files Job Traveler

Customer Requirements Machini sts requi re CNC programs that allow them to fabricat e part s meeti ng cust omer requirement s.

Information Flow Management Responsibility Product ion Manager assigns work t o machini st s and programmers as appropriate.

Resource Management Programmers generat e cutt er paths based on informati on from pri nt specif icat ions, soli d models, cust omer input and best manufacturing practices.


Customer Feedback

Measurement, Analysis and Improvement Compare result s of current ef fort s t o previous eff ort s. Improve programming process wit h corrective and prevent ive acti ons as required.

Product Realization


Program is generat ed to f abricat e cust omer pr oduct t hat sati sfi es all cust omer requir ements. Compare programs t o models and pri nt s. Program modified as required.

Product Out put

CNC Program Models Tools Required

Programs are available to run cust omer product .

Program results unsati sf actor y. Process stops.

Program works as designed or program requires modification as identified by results from machine process verif icat ion.


Information Flow

Customer Sati sfact ion

Customer Feedback

Program transferred to appropriate machine center (See Manufact uri ng after Receiving and Job Traveler, next page).




1.7

SAE AS9100

QM-001



Receiving Process, QMS 8 Quality Documents and Records QMS Processes

Packing Sli ps Material Certifications

Customer Requirements St. Vrain requires traceability of all material entering the f acili ty.

Information Flow Management Responsibility Establish requirements that all materials are accounted for and t raceable when entering t he St . Vrain facility.

Resource Management Est abli sh t racking syst ems for documentation, received materials and storage locations for received materials


Customer Feedback

Measurement, Analysis and Improvement Compare actual and expected material avail abilit y and/ or lost material . Improve receiving process with corrective and preventive actions as required.

Product Realization


File system for documentation. Syst em is in place t o document deliveries and status of pending deli veries. Mater ial s are st ored and t raceable. Invoices are paid.

Product Out put

Material t o st ock Material Certifications Packing Sli ps

Required mat erials will be available and traceable.

Material requirements have not been met. Process st ops.

When St . Vrai n personnel need material, that material is avail able. Feedback requir ed when material is not available


Information Flow


Customer Feedback

Material is available for manufact uri ng (See Manufact uri ng aft er Job Traveler, next page).




1.7

SAE AS9100

QM-001



Job Traveler Process, QMS 8 Quality Documents and Records QMS Processes

Job Traveler (Internal and external processes, P. O. dat a)

Customer Requirements St . Vrain personnel requir e a detailed list of processes required t o meet cust omer specificat ions.

Information Flow Management Responsibility Management has designed a syst em for the generation of job travelers t hat identi fy all processes required t o manufact ure cust omer product.

Resource Management Of f ice personnel generate j ob travelers based on input from customer, production, quality assurance, assembly and shipping.


Customer Feedback

Measurement, Analysis and Improvement Compare actual and expected result s fr om j ob t raveler. Improve j ob t raveler process wit h corrective and prevent ive acti ons as required.

Product Realization

Inputs Cust omer requirement s

Job Traveler Prints

Off ice personnel create t he j ob traveler based on the most current/ avail able cust omer requirements.

Product Out put Job traveler generated for use by production personnel assigned to manufacture cust omer product.


Information Flow

Customer Sati sfact ion Job traveler is inadequate. Process stops.

Customer Feedback

Job traveler i s adequate t o produce cust omer product . Job traveler is inadequate and needs modif icati on to produce part s.

Job traveler is issued to manufactur ing personnel (See Manufacturing, next page).




1.7

SAE AS9100

QM-001



Manufacturing Process, QMS 8 Quality Documents and Records QMS Processes

Machine Tools Raw Mat eri als Documentation In-Process/ FA Ins ection

Customer Requirements Cust omer requir es t he correct quantity of parts, on time and meeting all product specifi cations.

Information Flow Management Responsibility Management will coordinate programming, purchasing and qualit y assurance t o ensure pr oduct can be manuf actured t o meet urchase order re uirements.

Resource Management Operations manager, production manager, off ice manager, quali t y manager and machinists will work t oget her t o ensure cust omer cont ract requirement s are met.


Customer Feedback

Measurement, Analysis and Improvement Manufacturing process will be reviewed for problems. Improve manufacturing process with corrective and prevent ive acti ons as required.

Product Realization


Customer Product Quality Records

Machinists wil l manufacture parts as directed, primarily following the process defi ned in the j ob traveler and customer specifications. Support provided as appropri ate.

Product Out put Result of t he manufacturing process is cust omer product .


Information Flow

Customer Sati sfact ion Product does not meet customer specifications. Process st ops.

Customer Feedback

Product meets cust omer specif icat ions. Product does not meet customer specifications.

Product features have been generat ed and processing completed (See Inspection, next page).




1.7

SAE AS9100

QM-001



Inspection Process, QMS 8 Quality Documents and Records QMS Processes

Inspecti on Equipment Cali brat ion Syst em Inspecti on Procedures Ins ecti on Documents

Customer Requirements Cust omer product requi res f ull certification.

Information Flow Management Responsibility Management ensures capabili t y exist s t o certi fy t hat all processes and resulting products meet the cust omer’ s requir ements.

Resource Management Qualit y assurance manager coordinates specif icati on review, first article, in process and final inspection and documentation activit ies wit h t he machine shop.


Customer Feedback

Measurement, Analysis and Improvement Review inspection data and identi fy areas for i mprovement s. Improve manufacturing process with corrective and preventive actions as required.

Product Realization


Quality department will produce and procure inspection reports and material certifications for physical and chemical analysis. Coordinat e corrective act ions for

Product Out put

Quality Records

Finished product will be fully certified as it relates to customer requirements.

Product does not meet customer specifications. Process st ops.

Product i s cert if ied as meeting all cust omer requirements. Product is cert if ied, including nonconformances and corrective acti ons. Product cannot be


Information Flow


Customer Feedback

Product is acceptable (See Shipping, next page).




1.7

SAE AS9100

QM-001



Shipping Process, QMS 8 Quality Documents and Records QMS Processes

Packing Mat eri als Packing Slip Invoice Shi in Documentation

Customer Requirements Customer product will be identified and protected prior to delivery to the customer.

Information Flow Management Responsibility Management will ensure that St. Vrain has the capability to identify and protect customer product and deliver cust omer product on ti me.

Resource Management Qualit y manager wil l coordinate wit h offi ce manager, product ion, inspect ion and assembly t o ensure product has been processed according t o the j ob traveler.


Customer Feedback

Measurement, Analysis and Improvement Shippi ng dat a reviewed f or nonconformances. Improve shippi ng process wit h correct ive and preventi ve acti ons as requir ed.

Product Realization


Packaged Product Shippi ng Documentat ion

Shippi ng personnel wi ll have t he means t o ident if y, package and deliver all cust omer product s, including the required documentation.

Product Out put Product is identi fi ed, packaged, documented and delivered on time t o t he cust omer.


Information Flow

Customer Sati sfact ion Product cannot ship or product is received damaged. Process stops.

Customer Feedback

Cust omer recei ves product as requir ed by contr act. Cust omer does not receive product as required by cont ract.

Cust omer is contact ed and the entir e product realization process reviewed to determine level of customer satisfaction.




1.7

SAE AS9100

QM-001


Product Realizat ion Process – Suppor t ing Processes

Processes used as required defi ning, i mplementi ng, monitoring, maintaining and improving eff ectiveness of t he qualit y management syst em that support s St . Vrain Manufacturing’ s product realization process.

Document Control Process, QMS 2 Quality Documents and Records QMS Processes

Forms Purchase Order s Prints Qualit Documents, etc.

Customer Requirements Documents will be cont roll ed for content, accessibili ty, legibili ty, revision, storage and review.

Information Flow Management Responsibility St. Vrain management will ensure that all documents are controlled to t he extent r equired for providing accurate data when needed.

Resource Management Quali t y manager wil l maintain a syst em f or creat ing, receiving, issuing, retrieving, storing and reviewi ng documents.


Customer Feedback

Measurement, Analysis and Improvement Review document contr ol pr ocess t o determine ef fect iveness. Improve document control process with corrective and preventive actions as required.

Product Realization System provides documents that are current and legible.


Purchase Order s, Pri nt s, Job Travelers, Inspecti on Report s, Et c.

Product Out put Document control process maintains documents that are current, legible and retrievable.


Information Flow

Customer Sati sfact ion Nonconforming document s distri buted. Process st ops.

All personnel requiring documents t o perf orm job functi ons correctly have access to t hose document s.

Customer Feedback




1.7

SAE AS9100

QM-001



Processes used as required defining, implementi ng, monitoring, maintaining and improving eff ectiveness of t he qualit y management syst em that support s St . Vrain Manufacturing’ s product realization process.

Record Control Process, QMS 3 Quality Documents and Records QMS Processes

Forms Purchase Order s Prints Qualit Documents, etc.

Customer Requirements Records will be cont roll ed for accessibility, legibility, dist ribut ion, st orage and review.

Information Flow Management Responsibility St. Vrain management will ensure that all records are controlled to the extent required for providing legible data recall and distribution when needed.

Resource Management Quali t y manager wil l maintain a syst em for dist ribut ing, storing and retrieving documents.


Customer Feedback

Measurement, Analysis and Improvement Review record cont rol process to determine eff ectiveness. Improve record control process with corrective and prevent ive acti ons as required.

Product Realization


System pr ovides access t o recor ds t hat are legibl e. Records are st ored and easil y ret ri evable as required.

Product Out put

Purchase Order s, Pri nt s, Job Travelers, Inspection Report s, Et c.

All r equired records are ret rievable and legible.

Records are not retrievable or they are il legibl e. Process st ops.

All personnel requiring records to perform j ob functi ons correctly have access to t hose document s.

Preventive Action Correcti ve Action Nonconfor ming Materi al Measure and Veri f y

Information Flow


Customer Feedback




1.7

SAE AS9100

QM-001




Internal Audit Process, QMS 4 Quality Documents and Records QMS Processes

Audit Reports Corrective Actions

Customer Requirements St. Vrain shall establish and maintain a quality management system and perform periodic review.

Information Flow Management Responsibility St. Vrain management is committed to creating, implementi ng and maintaining a quality management system com li ant t o ISO 9001:2000.

Measurement, Analysis and Improvement

Resource Management St . Vrain has created t he quali t y manager posit ion and t hat individual has the responsibil it y f or implementi ng and maint aining the quality management system.

Customer Feedback


Regularly scheduled audit s review application of the quality management syst em and t he result s. Improve record contr ol process with corrective and preventive actions as required.

Product Realization


Audit Reports Corrective Actions

St . Vrain has document ed t he crit ical processes t hat defi ne the operat ion of the company. These processes are revised when appropriate.

Product Out put Quality management system is compli ant t o ISO 9001:2000 standard.


Information Flow

Customer Sati sfact ion QMS processes are f ound to be nonconforming. Process st ops.

Cust omers of St . Vrain have the assurance that t here is a functioning quality management syst em impl emented and maintained.

Customer Feedback




1.7

SAE AS9100

QM-001


Product Realization Pr ocess – Suppor t ing Processes


Nonconfor ming Pr oduct Process, QMS 5 Quality Documents and Records QMS Processes

Defective Material Report Corrective Action Report Return Material Authorization

Customer Requirements St. Vrain shall establish and maintain a process for resolving nonconformance issues.

Information Flow Management Responsibility St . Vrain management shall ensure t hat a process is in place t o prevent nonconforming product being shipped to the customer, unless documented and a roved.


Resource Management Quality manager is responsible for implementi ng and maint aining the nonconfor ming pr oduct process.

Customer Feedback


Review quali t y documentati on for t rends. Impr ove nonconfor ming material process with correct ive and preventive actions as required. Proact ivel y address pot ent ial nonconformance issues.

Product Realization


Defective Material Report Corrective Action Report Return Material Authorization

Nonconfor ming product deli vered. Process st ops.

Ident if y nonconforming product, segregate, identify problem to cust omer, correct pr oblem, address cause of problem and complet e qualit y records.

Product Out put Nonconforming product is correct ed. Only accept able product is delivered to the customer.


Information Flow

Customer Sati sfact ion Customer receives product that satisfies all specifications and requirements.

Customer Feedback




1.7

SAE AS9100

QM-001



Processes used as required defi ning, i mplementi ng, monitoring, maintaining and improving eff ectiveness of t he quali t y management syst em that support s St . Vrain Manufacturing’ s product realization process.

Corrective Action Process, QMS 6 Quality Documents and Records QMS Processes

Corrective Action Form

Customer Requirements St . Vrain shall invest igate, assign cause and implement corrective action on all nonconformances, as appropriate.

Information Flow Management Responsibility St . Vrain management shall ensure that a corrective action process is impl emented t o enable addressing nonconformances resulting from an rocess.


Resource Management Qualit y manager wil l implement a correct ive acti on process t o invest igate nonconfor mances, effect change and document the final outcome of the process.

Customer Feedback


Review corrective action process to verify result s. Modifi cat ions impl emented as necessary t o improve the corrective action process.

Product Realization

Inputs

Correct ive act ion pr ocess includes: Data f rom cust omers, int ernal data coll ecti on, measurement s, analysis and documentation of results.


Corrective Action Report

Nonconformance recurs. Process st ops.

Product Out put Result of t he correct ive action process is a report identifying the nonconfor mance, t he cause and t he soluti on.


Information Flow

Customer Sati sfact ion Cust omer agrees wit h solut ion and the nonconformance is closed. or Nonconformance recurs.

Customer Feedback




1.7

SAE AS9100

QM-001




Preventive Action Process, QMS 7 Qualit y Document s and Records QMS Processes

Prevent ive Acti on Form

Customer Requirements St . Vrain is commit t ed to proactive process improvement to prevent problems from occurring.

Information Flow Management Responsibility St . Vrain management shall ensure that a preventive action process is implemented t o facili tat e preventive action activities.


Resource Management Quality manager will facilitate and document t he preventi ve act ion process activities.

Customer Feedback


Review prevent ive act ion process data to verify results. Modifi cations implemented as necessary to improve the prevent ive act ion process. Management review.

Product Realization

Inputs

Identify potential problems, invest igate pot ential soluti ons, decide on course of action and develop a preventive action plan.


Preventive Action Report

Problems occur/ recur. Process st ops.

Product Out put Prevent ive acti on plan


Information Flow

Customer Sati sfacti on Cust omer r ealizes no problems from St . Vrain processes. Old problems st il l exist or new problem detected where not anticipated.

Customer Feedback




1.7

SAE AS9100

QM-001




Measurement and Analysis Process, QMS 8 Quality Documents and Records QMS Processes

Customer Feedback Measurement Dat a Management Review

Customer Requirements Output from quality management syst em pr ocesses must be measured to det ermine if result s are as specif ied.

Information Flow Management Responsibility St . Vrain shall ensure t hat a measurement and analysis process is defi ned and implemented t o det ermine t he result s of QMS rocesses.


Resource Management Quality manager is responsible for development of measurement and analysis tools to determine if processes perform as specified.

Customer Feedback


Data is reviewed and results compared t o expect ati ons. Modifi cations implemented as necessary t o improve pr ocesses. Management review.

Product Realization

Inputs

Measurement and analysis: Cust omer f eedback, dimensional data and st ati st ical data.


Customer Feedback Measurement Dat a Management Review

Problems still experienced by customer s. Process st ops.

Product Out put Result s of pr ocess are dat a that support s conclusions concerni ng the effectiveness of the QMS processes.


Information Flow

Customer Sati sfact ion Changes t o improve t he QMS processes are made based on valid data. Cust omers st il l experi ence problems.

Customer Feedback




SAE AS9100


2

Refer ence Document s

2.1

ISO Document s •

2.2

ISO 9001 : 2000

• •

2.3

MIL-I-45208 MIL-Q-9858 MIL-STD-105

Inspect ion Syst em Requirements Qualit y Program Requirements Sampling Procedures and Tables for Inspection by Attributes

St . Vrain Manufacturi ng - Pri mary Documents * AS9100 Required • • • • • • • • •

2.4

QMS-002 QMS-003 QMS-004 QMS-005 QMS-006 QMS-007 QMS-008 QMS-010 QMS-012

* * * * * * * * *

Document Cont rol Recor d Cont rol Int ernal Audit s Nonconf orming Product Corr ect ive Action Prevent ive Action Product Realization Product ion Provision Conf igurat ion Management

Ot her Document s •

• •

ANSI/ NCSL Z540-1-1994 Cali bration Laboratori es and Measuring and Test Equipment General Requirements ASME Y14.5 Dimensioning and Toler ancing LCCCN 75-1962 Machiner y’ s Handbook, Industrial Press Inc. Order of Precedence 1. 2. 3. 4. 5.

3

QMS – Requirement s

U.S. Government Documents (Delet e t his Section) •

2.5

QM-001

Contract Engineeri ng Documentation St . Vrain Manufacturing “ Quote Sheet” (Tender) Manufact uring Process Plan Machinery’ s Handbook

Glossary

Please refer t o St . Vrain Manufacturing ISO 9001:2000 Glossary 4

Quali t y Management System

4.1

General Requir ement s

In accordance wit h t he requirement s of t he int ernati onal st andard ISO 9001:2000, St . Vrain Manufacturing has established, documented, implemented and maintained a quality management syst em and cont inuall y improves it s effectiveness.




SAE AS9100

QM-001


St. Vrain Manufacturing shall: •

• •

•

• •

identify the processes needed for the quality management system and their application throughout the organization determines the sequence and interaction of t he processes determines criteria and methods needed to ensure that both the operation and control of t hese processes are eff ecti ve ensures the availability of resources and information necessary to support the operation and monit oring of t hese processes monit or, measure and analyze these processes implement acti ons necessary t o achieve planned result s and continual improvement of t hese processes

When St . Vrain Manufacturing chooses to out source any process that aff ects product conformit y with requirements, the organization providing the process shall ensure control over such process. Control of such outsourced processes shall be ident if ied wit hin t he qualit y management syst em. 4.2

Document ed Requirement s

4.2.1

General

St . Vrain Manufact uring’s documented syst em shall i nclude: • • • •

• •

4.2. 2

documented statements of a qualit y policy and qualit y objectives a quality manual documented procedures required by the international standard ISO 9001:2000 documents needed by t he organization t o ensure t he effective planning, operati on and control of its processes quali t y records required by t he int ernati onal st andard ISO 9001:2000 any addit ional qualit y syst em requirements imposed by the cust omer and/ or applicable regulatory authorit ies as t he need arises Qualit y Manual

St . Vrain Manufacturing has developed and maintains a qualit y manual t hat includes: •

•

•

t he scope of t he quali t y management syst em, incl uding details and justi ficat ion for any exclusions (ref er t o Sect ion 1.2 of ISO 9001:2000) t he documented procedures est ablished f or t he quali ty management syst em, or ref erence to t hem – when referencing t he document ed procedures, t he relat ionship between the requirements of AS9100 and the documented procedures are clearly shown a descript ion of t he interaction between the processes of t he qualit y management syst em




4.2. 3

SAE AS9100

QM-001


Contr ol of Documents

St . Vrain Manufacturing’ s documents requir ed by t he quali t y management syst em are controlled. St . Vrain Manufacturing recognizes quali t y records as a special t ype of document and t hey are controlled according to requirements given in Section 4.2.4. The document ed procedure, QMS-002 Document Control, defines contr ols needed: • • • • • •

•

•

4.2. 4

t o approve document s for adequacy pri or t o issue to review and update as necessary and re-approve documents t o ensure t hat changes and the current revision st atus of documents are identi fied t o ensure t hat r elevant versions of applicable documents are available at points of use to ensure that documents remain legible and readily identifiable t o ensure t hat documents of external ori gin are identi fi ed and their dist ribut ion controlled to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose Coordinate document changes wit h cust omers and/ or regulatory authori t ies in accordance wit h cont ract or r egulatory requirements Contr ol of Quali t y Records

St . Vrain Manufacturing has est ablished and controls quali t y records for t he purpose of providing evidence of conformit y t o requirements and of t he eff ective operat ion of t he qualit y management syst em. The documented procedure, QMS-003 Record Control, def ines controls needed. Qualit y records shall: • • •

remain legible be readily identifiable and retrievable have needed controls for identification, storage, protection, retrieval, retention time and disposition of quality records

The documented procedure, QMS-003 Record Control, defines the methods for controlling records t hat are created by and/ or ret ained by suppliers. All applicable records are available for review by customers and regulatory authorities in accordance with contract or regulatory requirements. 4.3

Confi guration Management

The documented pr ocedure, QMS-012 Confi guration Management, shall est ablish, document and maintain a confi gurat ion management process appropriat e to the product.




5

Management Responsibil it y

5.1

Management Commit ment

SAE AS9100

QM-001


St . Vrain Manufacturi ng’ s t op management shall provide evidence of commit ment t o the development and implementation of the quality management system and continually improving its effectiveness by: •

• • • •

5.2

communicating to the organization the importance of meeting customer, statutory and regulatory requirements establishing the quality policy ensuring t hat qualit y object ives are est ablished conducting management reviews ensuring the availability of resources Customer Focus

St . Vrain Manufacturing’ s top management shall ensure t hat cust omer needs and expectati ons are: • • •

determined converted into requirements fulfilled wit h the aim of achieving cust omer sat isfact ion

See Sect ions 7.2.1 and 8.2.1. 5.3

Qualit y Policy

St . Vrain Manufacturing’ s t op management shall ensure t hat t he qualit y policy: • •

• • •

is appropriate to the organization includes a commitment to comply with the requirements and continually improve the effectiveness of the quality management system provides a framework for est ablishing and reviewi ng quali t y object ives is communicated and underst ood wit hin t he organizat ion is reviewed for cont inuing suit abilit y

Refer t o Section 1.3 for full t ext of St . Vrain Manufacturing’ s quali t y policy. 5.4

Planning

5.4. 1

Qualit y Obj ecti ves

St . Vrain Manufacturing’ s top management shall ensure t hat quali t y obj ecti ves (see Secti on 1.4 and Section 7.1) are: • • • • •

established measurable consistent with the quality policy adequate f or meeting all product requirements est ablished at relevant functi ons/ levels within t he organization




5.4. 2

SAE AS9100

QM-001


Qualit y Management System Plannin g

St . Vrain Manufacturing’ s top management shall ensure t hat: •

•

the planning of the quality management system is carried out in order to meet the requirement s given in Secti on 4.1, as well as t he qualit y objecti ves in Secti on 1.4 the integrity of the quality management system is maintained when changes to the quali t y management syst em are planned and implement ed

5.5

Responsibil it y, Authori t y and Communicat ion

5.5. 1

Responsibil it y and Aut horit y

St . Vrain Manufacturing’ s t op management shall ensure t hat f uncti ons and interrel ati onships, including responsibilities and authorities are: • •

defined communicated wi t hin t he organizat ion

This is accomplished through the use of: • • •

5.5. 2

j ob descriptions performance appraisals organization charts Management Representat ive, Qualit y Manager

St . Vrain Manufacturing’ s top management has appoint ed a member of management , wit h t he title of Quality Manager, who, irrespective of other responsibilities, has responsibility and authority to: •

•

•

•

•

5.5. 3

ensure that processes needed for the quality management system are established, documented, implemented, and maintained report t o top management on the perf ormance of t he qualit y management syst em and any need for i mprovement ensure the promotion of awareness of customer requirements throughout the organization act as liaison with external parties on matters relating to the quality management syst em t he organizat ional fr eedom to resolve mat t ers pert aining t o qualit y Inter nal Communicat ions

St . Vrain Manufacturing’ s t op management shall ensure t hat appropriat e communication processes are establi shed between various levels and funct ions wit hin t he organizati on and t hat communication t akes place regarding t he eff ectiveness of t he quali t y management syst em.




5.6

Management Review

5.6.1

General

SAE AS9100

QM-001


St . Vrain Manufacturing’ s top management shall review t he quali t y management syst em at least once a year t o: • • • • •

5.6. 2

ensure its continuing suitability adequacy effectiveness assess opportunities for improvement evaluat e the need for changes, i ncluding t he quali t y poli cy and qualit y obj ectives Review Input

Management review input shall include: • • • • • • •

5.6. 3

result s of i nternal and external audit s cust omer f eedback process performance and product conformity status of preventive and corrective actions follow-up actions from previous management reviews planned changes that could affect the quality management system recommendati ons for i mprovement Review Out put

Information output from management review to appropriate recipients shall include any decisions and actions related to: • • •

improvement of t he eff ectiveness of t he quali t y management syst em and it s processes improvement of product related to cust omer r equirements resources needed

6

Resource Management

6.1

Provisions of Resources

St . Vrain Manufact uri ng shall st udy processes, det ermine and provide the resources needed: • • •

to implement and maintain the quality management system to continually improve quality management system effectiveness to enhance customer satisfaction by meeting customer requirements

6.2

Human Resources

6.2.1

General

St . Vrain Manufact uring personnel performing work affecti ng product qualit y are competent t o process the work based on appropriate education, training, skills and experience.




6.2. 2

SAE AS9100

QM-001


Competence, Awareness and Traini ng

St. Vrain Manufacturing shall: •

• • •

•

6.3

determine the necessary competence for personnel performing work affecting product quality provide t raining and t ake other acti ons necessary t o sati sfy t hese needs evaluate the effectiveness of actions taken ensure that personnel are aware of the relevance and import ance of t heir acti vit ies and how t hey cont ribute t o the achievement of t he qualit y obj ectives maintain appropriat e records of educati on, t raining, skil ls and experience (see Secti on 4.2.4) Infrastructure

St . Vrain Manufacturing shall det ermine, provide and maint ain the inf rast ruct ure needed to achieve conformit y t o product requirement s. The inf rast ruct ure at St . Vrain Manufacturing includes: • • •

6.4

building, workspace and associated utilities process equipment including hardware and soft ware supporting services including transportation and communication Work Environment

St . Vrain Manufacturing shall determine and manage the work environment necessary t o achieve conformity to product requirements including, but not limited to: • • • • •

temperature humidity lighting cleanliness protect ion fr om electrost atic discharge, as required

7

Product Realizat ion

7.1

Planning of Product Realizat ion

St . Vrain Manufacturing shall plan and develop t he processes needed f or pr oduct realizat ion. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see Section 4.1). In planning product r ealization, St . Vrain Manufacturing shall det ermine t he foll owing, as appropriate: • •

•

•

•

quali t y obj ectives and requirement s for the product the need to establish processes, documents and provide resources specific to the product required verification, validation, monitoring, inspection and test activities specific to t he product and t he crit eria for product accept ance records needed to provide evidence that the realization processes and resulting product fulf il l requir ement s (see Section 4.2.4) the identification of resources to support operation and maintenance of the product




SAE AS9100

QM-001


The output of t his planning shall be in a f orm suit able for t he St . Vrain Manufacturing met hod of operation. The document specifying t he processes of t he quali t y management syst em (including t he product r eali zat ion processes) and the resources appli ed to a specific product , proj ect or cont ract, is referred t o as t he qualit y plan. 7.2

Customer Relat ed Processes

7.2. 1

Deter minati on of Requirements Related t o t he Product

St . Vrain Manufact uring shall determine: •

•

• •

7.2. 2

requirements specified by the customer, including the requirements for delivery and post-delivery activities requirements not stated by the customer but necessary for specified use or known and int ended use st atut ory and regulat ory requirements relat ed to t he product t here may be addit ional r equirements, yet t o be identif ied, t hat St . Vrain Manufacturi ng will sati sfy upon discovery, as related t o t he cust omer's product Review of Requir ements Related t o t he Product

St . Vrain Manufacturing shall review the requirement s related t o the product. This review shall be conducted prior to St . Vrain Manufacturing’ s commitment t o supply a product t o the cust omer (e. g. submission of t enders, acceptance of contracts or orders, acceptance of changes t o contr acts or orders) and shall ensure t hat: • • • •

product requirements are defined contract or order requirements dif fering fr om those previously expressed are resolved St . Vrain Manufacturing has t he abil it y to meet t he defi ned requirement s Risks (e.g., new technology, short delivery time scale) have been evaluated

Records of t he result s of t he review and act ions arising from t he review shall be maintained (see Section 4.2.4). Where the cust omer provides no document ed st atement of requirement, t he cust omer requirements shall be confi rmed by St . Vrain Manufacturing before contr act acceptance. Where product requirement s are changed, St . Vrain Manufacturing shall ensure t hat relevant documents are amended and that relevant personnel are made aware of the changed requirements. 7.2. 3

Cust omer Communicat ion

St . Vrain Manufacturing shall det ermine and implement eff ective arrangements for communicating with customers in relation to: • • •

product information enquiries, contracts or order handling, including amendments customer feedback, including customer complaints




7.3

SAE AS9100

QM-001


Design and Development

St . Vrain Manufacturing does not perform product design and claims exclusion from t he requirement s of Sect ion 7.3, Design and Development . 7.4

Purchasing

7.4.1

Pur chasing Process

St . Vrain Manufacturing shall ensure t hat purchased product conforms to specified purchase requirement s. The t ype and extent of control applied to the supplier and the purchased product is dependent upon the effect of the purchased product on subsequent product realization or the final product. St . Vrain Manufacturing shall be responsible for t he quali t y of all products purchased fr om suppliers, including cust omer-designated sources St . Vrain Manufacturing shall evaluat e and select suppliers based on their abili t y t o supply product in accordance wit h St . Vrain Manufact uring requirement s. Crit eria for select ion, evaluation and re-evaluati on shall be establi shed. Records of t he result s of evaluations and any necessary acti ons arising from t he evaluat ion are maint ained (see Section 4.2.4). Refer t o QMS-009, Purchasing Crit ical Materials. St. Vrain Manufacturing shall: • •

•

•

•

maintain a register of approved suppliers that includes the scope of approval periodicall y review supplier perf ormance; records of t hese reviews shall be used as a basis for establishing the level of controls to be implemented define the necessary actions t o take when dealing wit h suppliers t hat do not meet t he requirements ensure where required t hat bot h St . Vrain manufact uring and all suppliers use cust omer-approved special process sources ensure t hat t he function having responsibili t y for approving supplier quali t y syst ems has the authority to disapprove the use of sources




7.4. 2

SAE AS9100

QM-001


Purchasing Informati on

Purchasing information shall describe the product t o be purchased, i ncluding, where appropriate: • • • •

•

•

•

•

•

•

•

requirement s for approval of product, procedures, processes and equipment requirements for qualification of personnel quality management system requirements the name or other positive identification, and applicable issues of specifications, drawings, process requirements, inspection instructions and other relevant technical data requirements for design, t est , examinat ion, inspect ion and related inst ructi on for accept ance by St . Vrain Manufacturing requirements for test specimens (e.g., production method, number, storage conditions) for design approval, inspection investigation or auditing requirements relative to supplier notification to St. Vrain Manufacturing of nonconforming product requirement s relati ve to arr angement s for St . Vrain Manufacturing approval of suppli er nonconforming material requirement s for t he supplier t o not if y St . Vrain Manufact uring of changes in product and/ or process definit ion and, where required, obt ain St . Vrain Manufacturing’ s approval right of access by St . Vrain Manufacturing, our cust omer, and regulat ory authori t ies to all f acilit ies involved in t he order and t o all applicable records requirements for t he suppli er t o fl ow down to sub-tier suppliers the applicable requirements in the purchasing documents, including key characteristics when required

St . Vrain Manufacturing shall ensure t he adequacy of specified purchase requirement s prior t o our communication with our supplier. 7.4. 3

Veri fi cat ion of Purchased Product

St . Vrain Manufacturing shall est ablish and implement t he inspecti on or other act ivit ies necessary for ensuring that purchased product meets specified purchase requirements. Where St. Vrain Manufacturing or its customer intends to perform verification at the supplier's premises, St . Vrain Manufacturi ng shall st ate t he int ended verif icat ion arrangements and method of product release in the purchasing information. Verif icati on activit ies may include: •

• • • •

obtaining object ive evidence of t he quali t y of t he product from suppli ers(e.g., accompanying documentat ion, cert if icate of conformit y, t est report s, st atist ical records, process control) inspection and audit at suppli er’ s premises review of required documentat ion inspection of pr oduct s upon receipt delegation of verification to the supplier, or supplier certification

Purchased product shall not be used or processed unti l it has been verified as conformi ng to specified r equirements unless it is released under t he posit ive r ecall procedure, QMS-017 Posit ive Recall .




SAE AS9100

QM-001


Where St. Vrain Manufacturing utilizes test reports to verify purchased product, the data in t hose report s shall be acceptable per appli cable specificat ions. St . Vrain Manufacturing shall periodically validate test reports for raw material. Where St. Vrain Manufacturing delegates verification activities to the supplier, the requirements for delegation shall be defined and a register of delegations maintained. Where St . Vrain Manufacturing or it s cust omer int ends t o perf orm verif icat ion at t he supplier’ s premises, St . Vrain Manufacturi ng shall st ate t he int ended verif icat ion arrangements and method of product release in the purchasing information. Where specified in t he contract, t he cust omer or t he cust omer’ s representati ve shall be aff orded the ri ght t o veri fy at t he supplier’ s premises and St . Vrain Manufacturing’ s premises that subcontracted product conforms to specified requirements. Verification by the customer shall not be used by St. Vrain Manufacturing as evidence of effective control of quality by the supplier and shall not absolve St. Vrain Manufacturing of the responsibili t y to provide acceptable product, nor shall it pr eclude subsequent rej ection by t he customer 7.5

Producti on and Servi ce Provision

7.5. 1

Cont rol of Product ion and Servi ce Provision

Planning shall consider, as applicable: •

•

•

•

t he est ablishment of pr ocess controls and development of control plans where key characteri st ics have been identif ied t he ident if icati on of in-process verif icati on point s when adequat e verificati on of conformance cannot be performed at a later stage of realization t he design, manufact ure, and use of t ooling so t hat vari able measurements can be taken, particularly for key characteristics special processes (see 7.5.2)

St. Vrain Manufacturing shall plan and carry out production and service provisions under controlled conditions. Contr olled conditions shall include, as applicable: • • • • • • •

•

• •

•

t he availabil it y of i nformation that describes t he characteri st ics of t he product the availability of work instructions the use of suitable equipment the availability and use of monitoring and measuring devices the implementation of monitoring and measurement t he implementat ion of release, delivery and post -delivery acti vit ies accountabili t y for all product during manufact ure (e.g., part s quanti t ies, split orders, nonconforming product) evidence that all manufacturing and inspection operations have been completed as planned, or as ot herwise document ed and authorized provisions for t he prevention, detecti on, and removal of foreign obj ects monitoring and control of utilities and supplies such as water, compressed air, electricity and chemical products to the extent they affect product quality crit eria f or workmanship, which shall be st ipulated i n t he clearest practical manner (e.g., writ t en st andards, representati ve samples or il lust rati ons)




SAE AS9100

QM-001


7.5. 1.1 Product ion Documentati on: Production operati ons shall be carried out in accordance wit h approved dat a. This data shall cont ain, as necessary: •

•

drawings, parts lists, process flow charts including inspection operations, production documents (e.g., manufacturing plans, traveler, router, work order, process cards); and inspection documents (see 8.2.4.1) a li st of specific or non-specific t ools and numerical cont rol (NC) machine programs required and any specific inst ruct ions associated wit h their use

7.5.1. 2 Cont rol of Production Process Changes: Persons authorized to approve changes t o the producti on processes shall be identif ied. St . Vrain Manufacturing shall identif y and obt ain accept ance of changes that require cust omer and/ or regulatory authorit y approval in accordance wit h cont ract or regulat ory requirements. Changes affecting processes, production equipment, tools and programs shall be documented. Procedures shall be available to control their implementation. The results of changes to production processes shall be assessed to confirm that the desired effect has been achieved without adverse effects to product quality. 7.5.1.3 Control of Production Equipment, Tools and Numerical Control (NC) Machine Programs: Production equipment, t ools and programs shall be validat ed prior t o use and maintained and inspected periodically according to documented procedures. Validat ion prior t o production use shall include verifi cat ion of t he fir st arti cle produced to design dat a/ specifi cat ion. St orage requirement s, including periodic preservati on/ condit ion checks, shall be est ablished for production equipment or tooling in storage. 7.5.1.4 Control of Work Transferred, on a Temporary Basis, Outside St. Vrain Manufact uri ng’ s Facili t ies: When planning to temporarily transfer work to a location outside St . Vrain Manufacturing’ s facili t ies, St . Vrain Manufacturing shall def ine t he process t o cont rol and vali dat e the quali t y of t he work. 7.5.1.5 Control of Service Operations: Where servici ng is a specified requirement, service operation processes shall provide for: • •

• • •

7.5. 2

a method of collecting and analyzing in-service data actions to be t aken where problems are ident if ied aft er delivery, including invest igat ion, report ing activit ies, and acti ons on service inf ormat ion consist ent wit h cont ractual and/ or regulatory requirements t he contr ol and updating of t echnical document ation t he approval, contr ol , and use of repair schemes t he contr ols required f or off -sit e work (e.g., St . Vrain Manufacturing’ s work undertaken at t he cust omer’ s facil it ies) Vali dati on of Processes for Product ion and Servi ce Provi sion

St . Vrain Manufacturing shall validat e any process for producti on and service provision where t he result ing output cannot be verified by subsequent monit oring or measurement. This includes any process where deficiencies become apparent only aft er t he product is in use or t he service has been delivered. Validat ion shall demonst rat e the abilit y of t he process t o achieve planned result s. Revision: C Date: 09/ 23/ 06 This document expires one day aft er printing



SAE AS9100

QM-001


St. Vrain Manufacturing shall establish arrangements for these processes including, as applicable: •

• •

• •

defined criteria for review and approval of the process followed by qualification and approval of special processes prior to use approval of equipment and qualification of personnel use of specif ic met hods and procedures in assuring control of t he significant operati ons and parameters of special processes in accordance with documented process specificat ions and changes theret o requirement s for records (see Section 4.2.4) revalidation

Refer t o QMS-009, Purchasing Cri t ical Mat eri als. 7.5.3

Identi fication and Traceabilit y

Where appropriate, St . Vrain Manufacturing shall i dentify t he product by suit able means t hroughout product realizat ion. Refer t o QMS-009, Purchasing Cri t ical Materials. St . Vrain Manufacturi ng shall maintain t he ident if icati on of t he configuration of t he product in order to identify any differences between the actual configuration and the agreed configuration. St . Vrain Manufacturing shall identify the product stat us wit h respect t o monit oring and measurement requirement s. When acceptance authorit y media are used (e. g., st amps, elect ronic signat ures, passwords), St . Vrain Manufacturing shall est ablish and document controls for t he media. Where tr aceabili t y is a requirement , St . Vrain Manufacturing shall cont rol and record t he unique identification of the product (see Section 4.2.4). According to t he level of t raceabil it y required by a cont ract, regulatory, or other est ablished requirement , St . Vrain Manufacturing’ s syst em shall provide for: • •

•

•

7.5. 4

identification to be maintained throughout the product life all the products manufactured from the same batch of raw material or from the same manufacturing batch to be traced, as well as the destination (delivery, scrap) of all products of t he same batch for an assembly, t he identi t y of i t s components and those of t he next higher assembly to be traced for a given product, a sequential record of its production (manufacture, assembly, inspect ion) t o be retrieved Cust omer Propert y

St . Vrain Manufacturing shall exerci se care wit h cust omer propert y whil e it is under St . Vrain Manufact uri ng control or being used by St . Vrain Manufact uri ng. St . Vrain Manufact uring shall identif y, verify, protect and safeguard cust omer propert y provided for use or incorporation into t he product. If any cust omer propert y is lost, damaged or ot herwise found to be unsuit able for use, this condition shall be reported to the customer and records maintained (see Section 4.2.4).




7.5. 5

SAE AS9100

QM-001


Preservation of Product

St . Vrain Manufacturing shall pr eserve t he conformit y of product during int ernal processing and delivery t o t he intended dest ination. This preservat ion shall include ident if icati on, handling, packaging, storage and prot ection. Preservation shall also apply t o the const it uent part s of a product. Preservation of product shall also include, where applicable in accordance with product specificat ions and/ or appli cable regulations, provisions for: • • • • • •

cleaning preventi on, detecti on and removal of foreign obj ects special handling for sensit ive product s marking and labeling including safet y warnings shelf life control and stock rotation special handli ng for hazardous materials

St . Vrain Manufacturing shall ensure that documents required by t he contract/ order t o accompany t he product are present at delivery and are protect ed against loss and deterioration. 7.6

Cont rol of Monit ori ng and Measuring Devices

St . Vrain Manufacturing shall determine t he monit oring and measurement t o be undert aken and the monitoring and measuring devices needed to provide evidence on conformity of product to determi ned requirement s (see Sect ion 7.2.1). See Calibrat ion, QMS-011. St . Vrain Manufact uring shall maintain a register of t hese monit oring and measuring devices, and define the process employed for their calibration including details of equipment type, unique identi fi cat ion, locat ion, frequency of checks, check method and acceptance crit eria. St . Vrain Manufact uring shall est ablish processes t o ensure t hat monit oring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirement s. St . Vrain Manufacturing shall ensure t hat environmental condit ions are suit able for t he calibrations, inspections, measurements and tests being carried out. Where necessary to ensure valid results, measuring equipment shall be: •

• • • • •

calibrated or verified at specified intervals, or prior to use, against measurement st andards t raceable t o int ernati onal or nati onal measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded adj ust ed or re-adj ust ed as necessary identifi ed to enable t he calibrat ion st atus t o be determined safeguarded from adj ust ments that would invalidate t he measurement result protected from damage and deterioration during handling, maintenance and storage be recalled to a defined method when requiring calibration




SAE AS9100

QM-001


In addit ion, St . Vrain Manufacturing shall assess and record t he vali dit y of t he previous measuring result s when t he equipment i s found not t o conform t o requirements. St . Vrain Manufacturing shall take appropriate action on the equipment and any product affected. Records of t he result s of cali bration and verif icat ion shall be maint ained (see Section 4.2.4). When used in the monitoring and measurement of specified requirements, the ability of the computer soft ware to sati sfy the intended application shall be confi rmed. This process shall be performed prior t o init ial use and reconfirmed as necessary. 8


8.1

General

St . Vrain Manufacturing shall plan and implement t he monit oring, measurement, analysis and impr ovement processes needed: • • •

t o demonst rate conformit y of t he product to ensure conformity of the quality management system to continually improve the effectiveness of the quality management system

This shall include determination of applicable methods, including statistical techniques, and the extent of their use. Note: According to t he nat ure of t he product and depending on the specified requir ement s, statistical techniques may be used to support: • •

design verification (e.g., reliability, maintainability, safety) process control: selection and inspection of key characteristics process capabil it y measurements statistical process control design of experiment inspect ion – mat ching sampling rate t o the crit icalit y of t he product and t o the process capabili t y Failure mode and eff ect analysis • • • •

•

•

8.2

Monit ori ng and Measurement

8.2. 1

Customer Sati sfacti on

As one of t he measurements of t he performance of t he quali t y management syst em, St . Vrain Manufacturing shall monitor information relating to customer perception as to whether St. Vrain Manufacturing has fulf il led cust omer requirement s. The methods for obtaining and using t his information shall be determined. 8.2. 2

Inter nal Audit

Foll owing procedures defined in QMS-004, St . Vrain Manufact uri ng shall conduct int ernal audit s at planned intervals to verify the quality management system: •

•

conforms to t he planned arrangement s (see Section 7.1), t o the requirements of t he International Standard ISO 9001:2000 and to the quality management system requirements est ablished by St . Vrain Manufacturing is effectively implement ed and maintained




SAE AS9100

QM-001


An audit program shall be planned and implemented, t aking into considerat ion t he st atus and import ance of t he process and areas t o be audit ed, as well as t he result s of previous audit s. The audit crit eria, scope, f requency and methods are defined. Select ion of audit ors and conduct of audit s ensure obj ectivit y and impart ialit y of t he audit process. Audit ors do not audit their own work. The responsibilities and requirements for planning and conducting audits, and for reporting and maintaining records (see Section 4.2.4) shall be defined in a documented procedure, QMS-004 Internal Audits. The management responsible f or t he area being audit ed shall ensure t hat acti ons are t aken wit hout undue delay to elimi nate detect ed nonconformit ies and t heir causes. Follow-up act ivit ies shall include the verif icati on of t he acti ons t aken and the reporti ng of verif icati on result s (see Sect ion 8.5. 2). Det ailed t ools and techniques shall be developed such as checksheets, process flowchart s, or any similar met hod t o support audit of t he qualit y management syst em requirements. The acceptabili t y of t he select ed tools will be measured against t he effectiveness of t he internal audit process and overall St . Vrain Manufacturing perf ormance. Internal audit s shall also meet contract and/ or regulat ory requirements. 8.2. 3

Monit ori ng and Measurement of Processes

St . Vrain Manufacturing shall apply suit able methods for monit oring and, where appli cable, measurement of t he qualit y management syst em processes. These methods shall demonstr ate t he abil it y of t he processes t o achieve planned result s. When planned result s are not achieved, correct ion and corrective action shall be taken, as appropri ate, t o ensure conformit y of t he product is achieved. In the event of pr ocess nonconformit y, St . Vrain Manufacturing shall: • • •

8.2. 4

take appropriate action to correct the nonconforming process evaluate whether the process nonconformity has resulted in product nonconformity identify and control the nonconforming product in accordance with clause 8.3 Monit ori ng and Measurement of Product

St . Vrain Manufacturing shall monitor and measures t he charact erist ics of t he product t o verif y t hat product requirements are fulfilled. This shall be carri ed out at appropriate st ages of t he product realization process in accordance wit h t he planned arrangement s (see Secti on 7.1) When key charact eristics have been identif ied, t hey shall be monit ored and controlled. When St . Vrain Manufact uri ng uses sampli ng inspect ion as a means of product acceptance, t he plan shall be st ati st icall y vali d and appropriate for use. The plan shall preclude t he acceptance of l ots whose samples have nonconformit ies. When requir ed, t he plan shall be submitted for customer approval. Product shall not be used until it has been inspected or otherwise verified as conforming to specified requirements, except when product is released under positive-recall procedures pending completion of all required measurement and monitoring activities. Evidence of conformit y wit h acceptance crit eria shall be maint ained. Records shall indicate t he person(s) aut horizing rel ease of product (see Section 4.2. 4). Revision: C Date: 09/ 23/ 06 This document expires one day aft er printing



SAE AS9100

QM-001


Product release and service del ivery shall not proceed unt il all t he planned arrangement s (see Section 7.1) have been sati sfactoril y complet ed, unless ot herwise approved by a relevant authority, and where applicable by the customer. 8.2. 4.1 Inspection Document ation Measurement requirement s for product or service accept ance shall be documented. This documentation may be part of the production documentation, but shall include: • • • •

crit eria for acceptance and/ or reject ion where in t he sequence measurement and testi ng operations are perf ormed a record of the measurement results t ype of measurement inst ruments required and any specific i nst ruct ions associated wit h t heir use

Test records shall show actual t est result s data when required by specificat ion or acceptance t est plan. Where required to demonstrate product qualification St. Vrain manufacturing shall ensure that records provide evidence that the product meets the defined requirements. 8.2.4.2 Fir st Art icle Inspect ion St . Vrain Manufact uring’ s syst em shall pr ovide a process for t he inspection, veri ficat ion, and documentati on of a represent ative it em from t he first producti on run of a new part, or following any subsequent change that invalidates the previous first article inspection result. 8.3

Control of Nonconfor ming Product

St . Vrain Manufacturing shall ensure t hat product s, which do not conform to product requirement s, are ident if ied and controlled t o prevent it s unintended use or deli very. The controls and related responsibilities and authorities for dealing with nonconforming product have been defined i n a documented pr ocedure, QMS-005 Nonconforming Product . St . Vrain Manufacturing’ s documented procedure shall def ine t he responsibili t y for review and authority for the disposition of nonconforming product and the process for approving personnel making t hese decisions. St . Vrain Manufacturing shall deal wi t h nonconforming product by one or more of t he foll owing ways: • •

•

by taking action to eliminate the detected nonconformity by authorizing it s use, release or acceptance under concession by a relevant aut horit y and, where applicable, by the customer by taking action to preclude its original intended use or application

St. Vrain Manufacturing shall not use dispositions of use-as-is or repair, unless specifically aut horized by t he cust omer, if : • •

the product is produced to customer design t he nonconformit y result s in a departure fr om contr act requirements




SAE AS9100

QM-001


Unless otherwise rest rict ed in t he contract , St . Vrain Manufacturing designed product which is controlled via a customer specifi cati on may be disposit ioned by St . Vrain Manufacturing as useas-is or repair, provided t he nonconformi t y does not result in a depart ure fr om cust omer specified requirements. Product disposit ioned for scrap shall be conspicuously and permanent ly marked, or posit ively controlled, until physically rendered unusable. Records of t he nat ure of nonconformit ies and any subsequent acti ons t aken, including concessions obt ained, shall be maint ained (see Sect ion 4.2. 4). When a nonconforming product i s correct ed it shall be subject t o re-verif icat ion to demonst rate conformit y t o t he requirements. When nonconformi ng product is det ected aft er deli very or use has st art ed, St . Vrain Manufacturing shall t ake act ion appropriate t o the eff ects, or potenti al eff ects, of t he nonconformity. In addition t o any cont ract or regulat ory aut horit y reporti ng requirement s, St . Vrain Manufacturing’ s syst em shall provide for t imely report ing of delivered nonconforming product t hat may aff ect reli abilit y or safety. Noti fi cat ion shall include a clear descript ion of t he nonconformit y, which incl udes as necessary parts aff ected, cust omer and/ or organizati on part numbers, quantity and date(s) delivered. 8.4

Analysis of Data

St . Vrain Manufacturing shall det ermine, collect and analyze appropriate data t o demonst rat e the suitability and effectiveness of the quality management system and to evaluate where continual i mprovement of t he qualit y management syst em can be made. This shall include data generated as a result of monitoring and measurement and from ot her relevant sources. The analysis of the data shall provide information relating to: • • •

•

cust omer sati sfacti on (see 8.2.1) conformance to product requirements (see 7.2.1) charact eristics and t rends of processes and products including opport unit ies for preventi ve action suppliers

8.5

Improvement

8.5. 1

Conti nual Improvement

St . Vrain Manufacturing shall cont inually improve the eff ectiveness of t he qualit y management syst em through t he use of t he qualit y policy, quali t y obj ectives, audit result s, analysis of dat a, corrective and preventive actions and management review. 8.5. 2

Corr ective Acti on

St . Vrain Manufacturing shall t ake action t o elimi nate t he cause of nonconformit ies in order t o prevent recurrence. Correcti ve actions shall be appropriat e t o the eff ects of t he nonconformities encountered.




SAE AS9100

QM-001


A documented procedure, QMS-006 Corrective Action, shall be established to define requirements f or: • • • • • • •

•

8.5. 3

reviewing nonconformities (including customer complaints) determining the causes of nonconformities evaluating the need for action to ensure that nonconformities do not recur determining and implementing actions needed records of t he result s of actions t aken (see Section 4.2.4) reviewing correcti ve act ion t aken fl ow down of t he correct ive act ion requirement t o a supplier, when it is determined that the supplier is responsible for the root cause specif ic acti ons where ti mely and/ or eff ective correct ive actions are not achieved Prevent ive Act ion

St . Vrain Manufacturing shall det ermine acti on to eli minate the causes of pot enti al nonconformit ies in order to prevent t heir occurrence. Preventi ve acti ons shall be appropriat e to the effects of the potential problems. A documented procedure, QMS-007 Preventive Action, shall be established to define requirement s for: • • • • •

determining potential nonconformities and their causes evaluati ng the need f or acti on to prevent occurrence of nonconformit ies determining and implementing action needed records of results of action taken (see Section 4.2.4) reviewing prevent ive action t aken



AS9100 Quality Manual

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