VDA 6.3 process audit
VDA 6.3 process audit
What´s about? Nearly all suppliers in the automotive supply chain are maintaining a quality system according to different standards (e.g. ISO 9001 or IATF 16949). This is generally required by the OEM´s (srcinal equipment manufacturer).
While qualityquality, systemthe is securing the of a supplier produce defined level ofthe product processes ofcapability an organization are thetomain baseato guarantee the performance of an organization and secure it´s successful future. The VDA 6.3 process audit is a standardized procedure to conduct process audits within a quality management system and assess their capability and performance. The VDA 6.3 is unique procedure without any comparable approach worldwide.
VDA 6.3 process audit
Qualification of VDA 6.3 process auditors. To conduct high quality process auditors the auditors must be qualified according to the following issues: •Acceptable work experience within the processes they would like to conduct process audits •Attend successfully a VDA 6.3 training session. •Pass the VDA 6.3 process auditor exam •Monitor, review and update the knowledge of process auditors, if they are conducting process audits.
VDA 6.3 process audit
Benefit for the organization. The process audits, internally or at the suppliers, are clearly identifying the weaknesses, risk and strengths within the audited processes. The process audit report will provide an excellence analysis of the audited process, so that effective improvement activities could be created. The potential risks identified by a process audit will help to avoid costs of warranties. The process audit will support the identification of waste and losses of a process to increase the efficiency of it. VDA 6.3 process audit will fully fill the requirement to conduct process audits due to customer specifics and IATF16949 in a most effective and efficient manner.
VDA 6.3 process audit
Customer specific requirements – BMW AG: BMW AG do require the VDA standards as additional requirements according to their customer specifics. Each supplier must conduct process audits, because it is also required by the IATF 16949. BMW AG itself conduct process audits based on VDA 6.3.
VDA 6.3 process audit
Customer specific requirements – Volkswagen AG: Volkswagen AG do require the VDA standards as additional requirements according to their customer specifics. This is mentioned in the Formel Q capabillity (page 4): •“Base of the process audit is the VDA 6.3 part B serial production including an assessment of all processes and procedures of the current production.” (page 29) •“The self assessment of a supplier has to be conducted according to VDA 6.3 followed by a product audit…” (page 23) •“The self assessment must be carried out minimum once a year…” (page 23)
VDA 6.3 process audit
Customer specific requirements – Daimler AG: Daimler AG do require the VDA standards as additional requirements according to their customer specifics. Each supplier must allow Daimler AG to conduct process audits also at their sub-suppliers. Daimler AG require a analysis of structure and risks within their processes.
AGENDA
• Structure of Automotive Quality Standards and link to VDA6.3 • Overview of the content of VDA6.3 • The assessment scoring methodology • Analysis of results • Auditing a new supplier • Questions
DEVELOPMENT OF AUTOMOTIVE QUALITY MANAGEMENTSTANDARDS 1999
2000
2002
2008
2009
2015
VDA 6.1
ISO/TS 16949
ISO/TS16949 2nd
ISO/TS16949 3rd Ed
Ed.
QS-9000 3rd Edition
ISO 9000:1994
ISO 9000:2000
ISO 9001:2008
ISO 9001: 2015
2016
ISO 9000 QUALITY MANAGEMENT SYSTEMS
ISO 9000 Basic Principles and definitions Definition of terminology for QM systems
ISO 9001 Requirements ( for Certification) Need, proof of ability
ISO 9004 Managing for the sustained success of an organization A quality management approach
DESCRIPTION OF THE STRUCTURE OF THE 9001 PDCA CYCLE
Automotive Specific Requirements for Quality Management VDA range of publications Procedures, operations & Q techniques
VDA 1 Documentation and providing evidence
International requirements
VDA 2
ISO 9001
Securing the quality of supplies
VDA 3 (Parts 1 & 2) Ensuring reliability with automobile manufacturers and suppliers
Legal requirements
VDA 4 ring binder & VDA 4.3 Securing quality before the start of full production
Automobile sector requirements
VDA 5 Suitability of test & inspection planning
VDA 6
VDA publications & IATF 1 6949
Customer-specific requirements
Fundamentals for quality audits
VDA 6.3 Process audit
VDA 6.4 QM system audit, production facilities
VDA 6.5
Manual
System overview
Product audit
VDA 6.7 Process audit – single production
VDA 10 Customer satisfaction
Who, what, when
VDA 13 Development of software-based systems
VDA 19 Technical cleanliness
How
VDA RGA Ensuring maturity for new parts
VDA RPP Robust production processes Note: This list is not exhaustive ! (see VDA QMC Webshop)
Results; evidence of effectiveness
TYPES OF AUDITS System audit To verify the overall effectiveness of the Management System
Process audit To verify the effectiveness of the product realisation processes
Product audit To verify that product conforms to defined specification throughout the manufacturing and dispatch processes
M Material T == Tool I = Inspect: • gauges • measure
ISO/TS16949 or VDA6.1
VDA6.3
VDA6.5
OVERVIEW OF THE STRUCTURE AND CONTENT OF VDA6.3
APPLICATION OF PROCESS ELEMENTS WITHIN A SPECIFIC PROJECT
SCOPE OF APPLICATION IN THE SUPPLY CHAIN
PROCESS ORIENTED APPROACH FOR THE IDENTIFICATION OF RISK
QUALIFICATION OF INTERNAL AUDITORS Audits the internal process chain w ithout considering the interfaces to suppliers and/or customers. • Good knowledge of quality tools and methods (e.g. VDA-MLA, DoE, FMEA, FTA, PPA, SPC, SWOT, 8D Method) • Knowledge of the relevant customer specific requirements • Knowledge of the relevant management system requirements (e.g. ISO/TS 16949 and respectively IATF 16949, DIN EN ISO 9001, VDA 6.1) • Specific knowledge regarding the product and process
QUALIFICATION OF SUPPLIER AUDITORS Audits the complete supply chain,the auditor carries out internal and external process audits with interface to suppliers and/or customers. • Excellent knowledge of quality tools and methods (e.g. VDA-MLA, DoE, FMEA, FTA, PPA, SPC, SWOT, 8D Method) • Auditor qualifications (negotiation, conflict management, audit procedure) • Knowledge of the relevant customer specific requirements • Knowledge of the relevant management system requirements (e.g. ISO/TS 16949 and respectively IATF 16949, DIN EN ISO 9001, VDA 6.1) • Specific knowledge regarding the product and process
CODE OF CONDUCT FOR AUDITORS • Process auditors must use their professional skills and judgement, while respecting the law and upholding the principles of honesty and integrity. • Process auditors must continually develop their expertise. They maintain their knowledge and skills with respect to audit procedures, QM systems, products and processes as well as specialised methods, procedures and relevant standards. They must be knowledgeable about the quality requirements for products as well as the specific process risks and the possible impact on the manufactured products. • Process auditors must at all times behave in a way that does not endanger the image and reputation of their own organization. • Process auditors must not accept assignments that would cause them a conflict of interests. • Process auditors must not accept assignments that they cannot carry out properly because of lack of knowledge. • Process auditors are bound to secrecy regarding confidential information that they have acquired through their professional activities.
VDA 6.3 APPROACH TO THE AUDITING
Assessment questions
Close-d questions
Assessed by auditor alone
answered? yes / no
Audit questions 1 n io t s e u q n e p O
2 n io t s e u q n e p O
3 n io t s e u q n e p O
4 n io t s e u q n e p O
Open questions asked during the audit
POTENTIAL ANALYSIS • Evaluation of potential new, unknown supplier ( Contender) • Evaluation of new locations or new technology or new products • Classification of the potential for product development and production
POTENTIAL ANALYSIS Evaluation of a potential analysis Each question is evaluated in terms of consistent compliance with the requirement under review and the risk involved. If a question is not answered (shown as n. a.), a reason for this must be stated. A maximum of 3 questions may be marked n. a. It should be noted that the comparability of results and the mutual acceptance of audit results from other parties may no longer apply. The assessment is marked, using the traffic light system of "red", "yellow" or "green" (see below). Assessment of individual questions The requirement of the question is not met.
R
The requirement of the question is partially met.
Y
The requirement of the question is met.
G
If a question is marked "red" or "yellow" the reasons and the relevant evidences must be documented.
POTENTIAL ANALYSIS
POTENTIAL ANALYSIS
SCORING • Assessing the individual questions: Points
Assessment of compliance with individual requirements
10
Full compliance with requirements
8 6
Requirements mainly* fulfilled; minor deviations Requirements partially fulfilled; significant deviations
4
Requirements inadequately fulfilled; major deviations
0
Requirements not fulfilled
Points
Evaluation of the compliance of the individual requirements Risk assessment from the perspective of the process/process step; specific
Risk assessment from the perspective of the product; specific
Systematic view; abstract
Technical requirements and specifications for the process are fulfilled
No product defects, the product meets the technical standards
Requirements are completely met
8
Small deviations in the process which do not affect compliance with the customer specifications or have an effect on following process steps
Some product defects but no influence on the function, use or further process steps
Requirements are mainly fulfilled; minor deviations
6
The process does not
Product non-conformities do
Requirements are
always meet the defined requirements. This has an impact on the customer or following process steps
not affect the function; however the failure has a negative impact on the use or on further process steps
partially met; significant deviations
4
The process does not meet the defined requirements and has a significant impact on the customer or following process steps
Product non-conformities have an impact on the function, the failure leads to usage restrictions, significant impact on the following process steps
Requirements insufficiently met; major deviations
0
The process is not capable of ensuring compliance with the defined requirements
Product non-conformities, no function, the use of the product is considerably reduced, further process steps are not possible
Requirements are not met
10
OVERALL LEVEL OF ACHIEVEMENT Classification
Overall level of achievement
Description of the classification
A
≥ 90%
Quality Capable
B
80- 89%
Conditionally quality capable
C
< 80%
Not quality capable
RULES FOR DOWNGRADING Downgrade from A to B, despite an achievement level of EG ≥ 90%
Process elements P2- P7 or process stage E1 – En
achievement
Sub-elements process analysis, productionEU1 – EU7 achievement level < 80%
At least one * question assessed as 4points
At least one question assessed as 0points
level < 80%
The rules for down-grading are used by the audit team. The audit report must state the down-grading rule which has been used.
RULES FOR DOWNGRADING Downgrade from A or B to C, despite an achievement level of EG ≥ 80%
Process element P2- P7 or process stage E1 – En
achievement
Sub-elements process analysis productionEU1 – EU7achievement level < 70%
At least one * question assessed as 0points
level < 70%
The rules for down-grading are used by the audit team. The audit report must state the down-grading rule which has been used.
IMPROVEMENT PROGRAM P7 7.1
x
7.2 7.3 7.4
x
7.5 7.6
y ll a r e n e G
Customer support / Customer satisfaction / Service Are the customer's requirements satisfied regarding QM system, product (on delivery) and process?
6
Delivery performance target not being met. Contingency plan not effective in the event of machine breakdown. no weakness identified no weakness identified Out of the 4 complaints sampled, 3 have been effectively closed. Complaint A45679, the root cause analysis had not been effectively completed
Is customer support ensured? Is the supply of parts ensured? If there are deviations from quality requirements, are failure analyses carried out and corrective actions implemented effectively?
10 10 8
Is there a process which ensures that analysis of defective parts is carried out? Are personnel qualified for the various tasks and are responsibilities defined?
10
no weakness identified
10
no weakness identified
to be complete d by organizat i on
to be completed by auditor
. s o P
Ques . No. P7
7.1 7.2 7.3
7.4 7.5 7.6
s t n i o P
Weaknesses / recommended activities, finding
Customer support / Customer satisfaction / Service Delivery performance target not being met. Contingency plan not effective in the event of machine breakdown. no weakness identified no weakness identified Out of the 4 complaints sampled, 3 have been effectively closed. Complaint A45679, the root cause analysis had not been effectively completed no weakness identified no weakness identified
6
10 10 8
10 10
Actions and root cause analysis Timing
Respon sibility
Effectivenes
32
While auditing the development of product and processes, we will first look at the guidelines of Red Book. We will give due importance to star questions. Thereafter, we will use Turtle Diagram to identify process specific risks. After covering the specific requirements of the Red Book, we will look at some of the commonly discovered risks which are revealed by the Turtle diagrams & which need to be added to the auditor’s basket of open ended questions and assessed additionally, by the auditing team. (This series of presentations will give you an idea of what is involved in these audits. However the expertise can come, only after undergoing an authorized training, followed by sufficient practise.)
33
P2 Project management 7 questions – incl. 1 new (2.5) •2 STAR Questions– different allocation •All questions=> Potential analysis •Revised content •Questions about change management are combined in one question •new: question about procurement activities in project
management •“QM-Plan” changed to “Advancedproduct quality planning”
34
2.1) Is a project management established with a project organisation? o o o o
Project Org Chart; Involvement of Suppliers in‘Project Management’; Evidence of ‘Specialists’ and ‘Technologies’; Verification of their qualifications.
2.2) Are all resources required for the project development planned and available and are changes shown?
• • • • •
Takes intoaccount customer’s requirements; Includes identification; Availability & capacity (workload wise) of in-house expertise; Changes in the project plan & organisation (interface with customer) are reported; Use of PERT & CPM; concurrent engineering practices.
35
2.3) Is there a project plan and has this been coordinated with the customer?
Product realization and Timing control plan; Review of milestones; Country specific certification requirements; Detailed activities concerning procurement.
2.4) Is the product quality planning implemented within the project andAdvanced monitored for compliance? Verification and validation of the product and process Requirements; Customer requirements in regard to quality plans & their adequacy.
36
2.5*) Are the procurement activities of the project implemented and monitored for compliance? Ensure that only approved and quality-capable suppliers are used; Supplier selection and award criterial; Award amount and delivery target date; The suppliers for facilities, machinery, tools, test and measurement
systems and services (such as development, laboratories and maintenance etc.) are integrated.
2.6*) Is change management within the project ensured by the project organization? Evaluation must include the risk assessment for the product quality as well as the deadlines; Changes must be discussed with & agreed upon by customer; Controlled procedure for change management. 37
2.7) Is there an escalation process established and is this effectively implemented?
Project risks are identified, assessed and reduced through appropriate
measures; Special risks of technologies, suppliers & supply countries are taken into account during escalation management; Identification of contact persons & decision makers in the escalation process.
38
Additional risks likely to get discoveredthru’ Turtle Diagram Project Planning activities are done without real involvement of suppliers. Actual time available for specialists to support the project, could be inadequate. Activities which are supposed to have been done by CFT, are in reality done by a single person, though names of all team members are mentioned. Country specific regulations of Safety and Environment are not fully considered during planning. Waste management plans are inadequate. PERT and CPM analysis is not done / adhered to. Concurrent engineering teams are not used. Risk assessment & qualification of all components under development is not done as expected by VDA. Evidence of escalation process in case of major delays.
39
P3 Planning the product and process development •5 questions – incl. 1 new (3.4) •One STAR -Question •2 questions for potential analysis •new: Activities to ensure customer care •Questions about procurement scope moved to P2 •Embedded Soft Ware considered (in questions 3.1,
3.2, 3.3)
40
3.1) Are the specific product and process requirements available?
• • • •
Contract review; Customer requirements (Legal requirements); Purchasing conditions & QM specific requirements; Logistic planning.
3.2*) Can the manufacturing feasibility be evaluated according to the product and process requirements? o
o o
o
Manufacturing feasibility of technology, function, quality, logistics, software, etc; Also for Buildings, premises, CAM, CAQ, Product / process innovation; Inter-divisional manufacturing feasibility analysis (for example, sales, development, purchasing, production planning, production, QM planning, logistics); Requirements from ‘P7’ also need be considered. 41
3.3) Are the activities for the product and process development planned in detail?
Milestone planning aligned withcustomer’s; Evidence of QFD, DoE; Product / process FMEA etc; Planning for reliability testing and functional testing.
3.4) Are the activities for customer support / customer satisfaction / customer service planned? The customer requirements are taken into account for failure analysis; NTF Processes; Inspection Planning for standard and stress testing; Safeguard for emergencies.
42
3.5) Have the necessary resources been taken into account for the product and process development? Controlled procedure for planning resources should include Qualified
personnel, budgets, infrastructure, test equipment, lab facilities, machines, plant etc; And outside processes/ services; Demand analysis and Bottleneck identification; Use of problem solving techniques.
43
ADDITIONAL RISKS LIKELY TO GET DISCOVEREDTHRU’ TURTLE DIAGRAM Project Planning activities are done without real involvement of suppliers.. Actual time available for specialists to support the project, could be inadequate. Activities which are supposed to have been done by CFT, are in reality done by a single person, though names of all team members are mentioned. Country specific regulations of Safety and Environment are not fully considered during planning. Waste management plans are inadequate. PERT and CPM analysis is not done / adhered to. Concurrent engineering teams are not used. Risk assessment & qualification of all components under development is not done as expected by VDA. 1 3
P4 Implementation of the product and process development 8 questions – including 2 new (4.5, 4.7) 3 STAR -Questions 3 questions for the potential analysis– different allocation Product and process in one question Embedded software (4.1, 4.4, 4.5, 4.8) Infrastructure themes in 4.3 to material resources Control plans = production and testing requirements Purchased products in 4.1 Project transfer to the series = 4.8 4.1, 4.2 and 4.8 (2010) combined in one question (4.1.)
45
46
4.1*) Are the actions from the plans implemented for productand process development?
• When carrying out the product FMEA the proposed manufacturing site for the production shall be included; • QFD, DoE, FMEA, Poka Yokes, SPC, Statistical trial planning; Environmental simulation,simulation testing (e.g. salt spray test); • Planning of project sequence including trials. The out-sourced products and services are services are taken into account; trialsto & ensure system customer testing; requirements in the development phase •• Fitment Risk analysis 4.2) Are human resources available and are they qualified to ensure the start of the series? o Personnel resources qualified for the relevant tasks, are planned ; Training need identification, proof of training, training effectiveness;(This also applies to the staff of external service providers.) o
Analysis is carried out of bottlenecks and additional demands;
o
Knowledge of foreign languages.
4.3) Are the material resources available and suitable to ensure the start of the series?
Availability of test equipment, laboratory equipment, machinery; equipment, and the utilization of machinery and equipment;
Outsourced processes are considered; Process Development; - Facility planning, layout, Machinery and equipment planning - Quantities and throughput times, Transport routes, containers, storage - Supporting processes for example from logistics and IT
48
4.4*) Are the required approvals and releases for the product and process development available?
PPAP report with signed PSW & PPAP lot sample; The actions from the FMEA have been confirmed in their effectiveness; Product Development
- Specifications, drawings, requirement specifications, FMEA IMDS, - Product testing, installation inspection, function / endurance testing, environmental simulation - Confirmation with legal requirements - Development releases from customers. - Logistics concept (e.g. suitability of packaging through sample shipping) - Proof of capability of special characteristics - Capacity studies - Tool approvals 49
4.5) Are the manufacturing and inspection specifications derived from the product and process development and are they implemented? The manufacturing and inspection characteristics contain all characteristics
from the product and process development (including special characteristics); These must take into account all the components, assemblies, subassemblies, parts, software and materials including manufacturing processes that are part of the product; Product audits, layout inspection and a functional verification plans; Process development;
- Risk analysis (FMEA, FTA etc.) - Production control plan (pre-series, series) - Product inspection / audit plan & Response / reaction plan - Layout inspection / functional verification plan - Series release (first and last piece) & Testing within the series 50
4.6) Is a production trial run carried out under series conditions for the series release?
Quality capability of the entire production process is given under serial production conditions (tools, equipment, cycle time, personnel manufacturing and inspection specifications, I,M & TE);
Identification of bottlenecks & quality issues thru’ this run; - Equipment and infrastructure are ready for start of series (measurement reports) - Work/inspection instructions - Production tests according to customer schedule - Packaging requirements
51
4.7) Are the processes established for securing customer care / customer satisfaction / customer service as well as the field failure analysis? Customer requirements for the supply of parts during the product
lifecycle are established. The planned processes for the continuous series supply including safety margins for emergencies are available; The analysis process for 0-km and field complaints is established taking
customer requirements for field failure analysisinto account; If external sites are used for analysis, the interfaces are defined and
evidence of the presence of the required equipment and capacity is available;
Initiation criteria must be agreed with the customer for the‘NTF’.
52
4.8*) Is there a controlled method for the product handover from development to serial production?
• A process exists for transferring work results from the project to the production; • The material resources include buildings, test facilities, laboratory facilities, equipment, facilities, etc. These are available and have been released; - Customer requirements - Handover protocols/ checklists with handover criteria - Acceptance reports - Production metrics such as OEE, rejects - Experience from the ongoing project - Measurement capability
53
Additional risks likely to get discoveredthru’ Turtle Diagram
1. 2. 3. 4. 5. 6.
Process specific measures from Product FMEA Establishing & marking of special characteristics How is the inspection / test plan generated. Is acceptance criteria very clear Checking suitability of packaging by trial despatch Establishing production rate as per takt time.
7. 8. 9. 10. 11.
Process parameters like Pressure, temp, time, etc. Information on current non-conformities if relevant Analysis of OEE. Testing plans for software. Are pending actions from ‘Hand over sign-off’ completed in timely manner.
54
55
While auditing the Serial Production, we will first look at the guidelines of Red Book. We will give due importance tostar questions. Thereafter, we will use Turtle Diagram to identify process specific risks. After covering the specific requirements of the Red Book, we will look at some of the commonly discovered risks which are revealed by the Turtle diagrams & which need to be added to the auditor’s basket of open ended questions and assessed additionally, by the auditing team. (This series of presentations will give you an idea of what is involved in these audits. However, the expertise can come, only after undergoing an authorized training, followed by sufficient practise.)
56
P5 Supplier management •7 questions •2 Star Questions •5 questions for potential analysis •Minor changes only in the content of the
requirements
57
5.1) Are only approved/released and quality capable suppliers selected?
• • •
•
An evaluation as per documented procedure of the qualification capability of the supplier must be available. Audits done by CFT and also by other OEMs. Upgrading programs for non performing suppliers; Also applies to suppliers of research and development , prototype, software, equipment, machinery, tools, Service providers (eg. Sorting companies), External testing labs, Suppliers in outsourced processes
5.2) Are the customer’s requirements taken into consideration in supply chain? o
o o o
The communication of customer requirements must be regulated and traceable. Change management must be audited; QAA (quality assurance agreements) Legal, regulatory requirements 58
5.3) Have target agreements for the delivery performance been agreed with supplier & implemented?
Measurable targets for quality, delivery quantity (batches), punctuality, must be checked and evaluated within a defined period. QM agreements includes escalation mechanisms.
5.4*) Are the necessary releases / approvals available for out sourced products and services? Approvals, releases, PSW & PPAP for build samples & trials. Evidence of change management from Customer to sub-supplier. Compliance with EU safety data sheets, MSDS, IMDS & REACH.
59
5.5*) Is the quality of the outsourced products & services ensured? Deviations from the supplier quality; Evaluation of main failures, ppm evaluations, 8D reports, testing in accordance with ISO/IEC 17025) for raw materials (material
certificates) and finished parts. 5.6) Are incoming goods stored appropriately? FIFO, Identification & batch traceability, no wrong identification, Labelling (traceability / test status / work sequence / use status); the transport and storage conditions must be defined and verified; Secure storage for suspect & quarantined products.
60
5.7) Are personnel qualified for the various tasks & responsibilities defined? “Qualification requirements”rather than “training requirements” mustbe
determined for each employee; Knowledge must be available Of previous complaints regarding out sourced material, Product / specifications / special customer requirements, Foreign language.
61
Additional risks likely to get discoveredthru’ Turtle Diagram • Evidence of supplier discussions & regular support. • Supplier audit must actually be done by a CFT & not by a single person. • Inspection and measuring records of improved components. • Workshops, reducing defects & inventory. Information flow in case of non-conformity or loss. • Emergency strategy in case of supply bottlenecks Kanban, Pull system, JIT, FIFO & traceability • Safety against mix ups. • Audits, statistics, 8-D methods & Customer satisfaction.
62
P6 Process analysis production •Total of 26 questions in 6 groups– 6.1, 6.2, 6.3, 6.4, 6.5 &
6.6 •8 Star Questions •15 questions for potential analysis •Transport and handling of parts is separately evaluated •No structural changes in the elements only adjustments to
content
63
P6.1 Process analysis => Input to the process • 5 questions • 1 Star Question different allocation • 1 questions for potential analysis • Content revised • Allocation for evaluation of transport and handling of parts
unchanged • Embedded software (6.1.5)
64
6.1.1) Has the project been transferred from development to serial production and is a reliable start guaranteed?
• • • •
A complete production process / product release must take place All un-resolved issues must get closed before the first production shipment; PSW is signed Process transfer sign off is available.
6.1.2) Are the necessary quantities / production batch sizes of incoming materials available at the agreed upon time and at the correct storage / work-station? o
o
o o
The correct incoming product, quantity, packing, with the correct documentation, at the agreed time and at the agreed place. Evidence of PULL system with FIFO, return of the residual quantity after the batch gets over, Change status indication & Special requirements (ESD protection etc.) of packaging for the product. 65
6.1.3) Are incoming materials stored appropriately and are the means of transport means / packing facilities suitable forthe special characteristics ofthe incoming materials?
How is the suitability of Store areas /work-stations / containers ensured? Are suitable transportation units used to protect the products from damage and contamination? Storage times & Use-by dates.
6.1.4) Are the necessary identifications / records / approvals available and allocated appropriately to the incoming materials? Customer specific regulations for the identification & traceability, Documentation of special releases, “Test results of characteristics” with special requirements regarding
documentation
66
6.1.5*) Are the changes to the product or the process in the course of serial production tracked & documented? Management of ECR & ECNs, Ensuring at all times the correct design level is used– also for
software, Up-dates of the FMEA (Product and Process)
67
Additional risks likely to get discoveredthru’ Turtle Diagram • Sufficient & suitable transport means. • Minimal / no intermediate storage, management of holding stores & quarantine • Only transfer of satisfactory parts. • •
Labels, tags & latest revision number. Likelihood of environmental influences.
68
P6.2 Process analysis=> Management of Process
•5 questions •2 Star Questions – different allocation •4 questions for potential analysis– different allocation •Allocation for evaluation of transport and handling of parts not
changed •Content revised •Question 6.2.3 (2010) – suitability of manufacturing facilities– moved to 6.4.1 •Embedded software (6.2.5)
69
6.2.1) Are the requirements of the control plan complete and have they been effectively implemented?
•
• •
Process parameters & Tolerances influencing product characteristics and/or quality must be fully stated in control plans; The production and test/inspection documents are complete and available and based on the production control plan; Required action plan for process disturbances are known, initiated and documented.
6.2.2*) Does a repeat release for the restart of production take place? o o o
Defined criteria for triggering a production repeat release; Deviations and measures taken are documented; Tooling layout / master parts / setting pieces / red rabbit.
70
6.2.3) Are special characteristics managed in the production?
SPC / pre control charts for critical & significant characteristics, Cpk, Cmk, machine capability checks Records of deviations with action taken; Proof of inspection process with Inspection results.
6.2.4*) Are non-approved and / or defective parts managed? Scrap and parts for reworking are separated and safely removed;
Labelling of scrap, rework & setting parts and also for the quarantine area; Reworking criteria / testing are defined, known and approved by customer. Setting pieces & masters are labelled and protected against accidental use.
71
6.2.5) Is the flow of materials and parts secured against mixing / wrong items? Material and parts flow; Risk Analysis, Poka Yoke against mix ups. The reuse of residues, separated parts, reworked parts, reusable parts
from audits, inspected items, outsourced processed (e.g. sorting service) etc. must be clearly defined (including regulations for traceability).
72
Additional risks likely to get discoveredthru’ Turtle Diagram • Inspection frequency, Red Rabbit validation frequency, • Confirmation of process parameters like Pressures, timing, temperature and CNC programs • Tool layout, sister tool compatibility and tools pre-setters Tool inserts their grades & geometry.
• Changed production parameters.
73
P6.3 Process analysis => Personnel resources • 3 questions •1 Star Question •2 questions for potential analysis •Content revised and reorganised
74
6.3.1*) Are the employees able to fulfil their given tasks?
• • • • •
Authorities, responsibilities, job description Qualification matrix for all. Induction training & knowledge of problems and their effects, Evidence of qualifications & capabilities like forklift driving license, welding certificate, soldering certificate, vision test, hearing test; Applies to internal and external temporary employees.
6.3.2) Do the employees know their responsibilities and authority in the monitoring of the product and process quality? o
o
o
o
Responsibilities, duties and authority of the employees like process release, employee self-inspections, stopping the process; Tasks / function of the product and what happens when it malfunctions. Employees receive regular information on the current quality, both internally and with the customer. Applies to internal and external / temporary employees
6.3.3) Are the necessary personnel resources available?
Shift plans with balance of qualification matrix. A scheme exists for supporting areas that are not continually in use like laboratory, standards room etc. Fluctuations in on call staff and through absences (e.g. illness, holidays, training) are taken into account in the schedule.
76
Additional risks likely to get discoveredthru’ Turtle Diagram 1. 2. 3. 4. 5. 6. 7. 8.
Co operation & contribution to improvement programs, Interpretation of control charts & control plans. Ability & authority to stop production. Tidiness, cleanliness & 5 S. Participation in JH pillar of TPM. Instructions for handling products having special requirements. Quality circles & their effectiveness. Self assessments.
77
P6.4 Process analysis => material resources •5 questions •2 *-Questions •4 questions for potential analysis– different allocation •Content revised •No questions to transport and handling of parts •New question: Suitability of manufacturing facilities– previously in
6.2 (2010)
78
6.4.1*) Can the product-specific requirements from the customer be met with the manufacturing equipment?
• •
•
Do the products meet the customer specifications; Evidence of machine / process capability for spl. characteristics / process determining Parameters (e.g. pressure, time, temp.); Layout and condition of the equipment, tools, fixtures and handling facilities meet the requirements under real production conditions;
• Capability of replacement tools / reproducibility of fixtures, specifications. 6.4.2) Is the maintenance of the mfg. equipment & tools controlled? o
o o
o
Scheduled / unplanned maintenance activities have been carried out & analysed for improvements; Process for analysing & optimization of utilization of machine tools etc; Key processes and critical equipment are identified and preventive as well as proactive maintenance activities are carried out; Tool life and conditions are monitored; 79
6.4.3*) Can the quality requirements be effectively monitored with the measurement and testing facilities in use?
The test, inspection and measurement facilities used are suitable & as per control plan; The test, inspection and measurement facilities used are suitable; Proof of the capability of inspection equipment and Processes; Identification & calibration system of the equipment; Comparison of in-house results with those at customer’s.
6.4.4) Are the work and inspection stations appropriate for the needs? Ergonomic suitability of work stations; Lighting, Cleanliness and tidiness, Climate control, Noise pollution; Clean rooms; The work-place layout is adapted ergonomically to the process; Also applies to permanent and temporary established rework, sorting and
inspection stations
6.4.5) Are tools, equipment and testing equipment stored properly? Tools, equipment and testing equipment (including gauges, tools,
equipment and test equipment not in use or not yet released) must be stored and managed properly. Change history, Defined storage location; Status identification. Identification showing customer's property, products /tools / devices
provided on loan.
81
Additional risks likely to get discoveredthru’ Turtle Diagram
• Monitoring of MTBF / MTTR and steps taken for their improvement.
• Maintenance of conveyors, chutes, trolleys & trucks. • Health & safety at work. • Standstill of the process / equipment,it’s analysis, corrective and preventive action.
• Managing 5 S & Visual workplace. • Revision to PM plan after major breakdown.
82
P6.5 Process analysis => Effectiveness, efficiency, waste avoidance • 4 question • 1 Star Question • 2 questions for potential
analysis • Content revised
83
6.5.1) Are there targets set for the manufacturing process?
• •
Target requirements are defined, agreed, achievable based upon Customer requirements and up-to date. Targets include Number of parts produced per unit of time; Rework, scrap, production runs with no reworking, first time through quality, first pass yield;
•
Quality metrics include failure rates, audit results;
• •
Process metrics (process capability); Reduction of waste of energy and process materials).
•
Audit of A, P & Q factors of OEE.
84
6.5.2) Is quality and process data collected and analysed? o o o
o
o o o
Defect frequency cards; Control charts; Special characteristics; Process parameters (temp, time, pressure); Factory data collection, Special incidents are documented in shift / equipment book. Fault signals like plant standstill, powerfailure, programme error message; Parameter changes are analysed for improvement. SPC, Pareto analyses, Cause & effect diagrams, Risk analysis (FMEA, FTA). Wherever applicable, FMEA is revisited & cascading document changes take place.
85
6.5.3*) In the case of deviations from product & process requirements, are the causes analysed and corrective actions checked for effectiveness.
Corrective & preventive actions for failures are immediate, effective and known to all concerned; Knowledge & successful use of Cause & effects diagram- Taguchi, Shainin - 5 W method; Nonconformities that affect the properties of the delivered
product are communicated to the customer. 6.5.4) Are processes & products audited regularly? The process and product audits carried out effectively at regular frequency;
Root causes are analysed for deviations discovered; Process audits cover parameters and capabilities; Product audit to cover specified characteristics,Labelling, packaging; Capacity of the test equipment, Software version. 86
Additional risks likely to get discoveredthru’ Turtle Diagram • Data acquisition & use of I O T. Recorders & their status / adequacy,
• Analysis Corrective / preventive action for Plant Standstill / Power off. • Cost of poor quality • Cost optimization and control of 7 wastes. • Re-occurrence of same NCs in subsequent audits. Auditor qualifications.
87
P6.6 Process analysis => Result/Output •4 questions •1 Star Question •2 questions for potential analysis •3 questions to transport and handling of parts (separate
evaluation) •Content revised
88
6.6.1) Do the quantities/production batch sizes match needs and are they systematically directed to the next process step?
•
Audit of ‘D’ type characteristics
• •
Dock audits for customer requirements; audit Millipore ratings,
•
Tests, checks and inspection procedures are agreed with customer and documented, Audit of Endurance tests and of Production tests under peak production
•
conditions. Communication in the event if shipment is blocked / hold.
89
6.6.2) Are products/components stored in an appropriate manner and are transport facilities/packing arrangements suitable for the special characteristics of the products/components?
o
o
o o o
o
Internal packing instructions are known and implemented (not only customer-specific), Parts must be protected against environmental and climatic influences during storage and transport. Audit of ESD protection to electronic parts. Monitoring of storage periods / quantities stored; Customer specific packaging instructions (inc. packing supplied by the customer); Information on available stock levels; Substitute packaging, Requirements for cleaning packaging.
90
6.6.3) Are the necessary records / releases retained?
Customer requirements for the labelling of the release status on containers / batches / carriers / components and also on reworked parts must be implemented and documented; Customer specifications, Customer's identification requirements; Customer’s requirements for archiving time limits, Archiving requirements/ regulations (EDP, paper, fire protection, legibility, Last piece inspection; Identification of special releases.
91
6.6.4*) Are the customer requirements met at the delivery of the final product? If deviations occur, corrective actions are defined and
implemented; Quality agreements with the customer; Customer specific requirements; Customer requirements for the identification of special
characteristics; The planning of the shipping audit; Storage / recall processing / parts supply / shipping, Target
agreements,
92
Additional risks likely to get discoveredthru’ Turtle Diagram 1. hold . 2. 3. 4. 5.
Evidence of Communication process in the event if shipment of product is blocked / Defined storage / holding locations availability. Packing WI Customer requirements for identifying reworked parts. Special releases/ deviation approvals, product traceability
93
P7 Customer care, customer satisfaction, service • • • •
5 questions 2 *-Questions – new allocation 4 questions for potential analysis Failure analysis as a general requirement is integrated into complaint‘s management (specific question removed) • Question 7.1 has been redefined
94
7.1) Are all requirements related to QM System, Product and Process fulfilled?
• Quality agreements with the Customer is fulfilled. • Layout inspection and a functional verification concept e.g. carried out product audits, function tests, endurance tests • Supply guarantee after serial production • Inclusion of sub-supplier for the supply of spare parts & Supply guarantee after serial Production • Certification of the QM system 7.2) Is customer service guaranteed? o Competent contact personnel ensure communication in accordance with the customer specifications o Knowledge of the product application and of problems with the product and complaints regarding the product or Transport o Access to customer portals in accordance with the customer specific agreement is ensured. o
World-wide customer service
7.3*) Is the supply of parts guaranteed? Concepts to ensure supplies including in emergency are available Contingency plans including for alternative production, suppliers, transport in line with VDA’sstandard for Robust Production processes, are available. Capacity and reaction time for sorting actions & Use of external capacity Procedures must be in place which guarantees that the organisation informs the customer immediately when supply shortages are detected. Regulations covering authority to make decisions & escalation paths. 7.4*) If there are deviations from quality requirements, are failure analyses carried out and corrective actions implemented effectively? Processing complaints & 8D process also for 0 km andfield complaints. Procedures for failure analysis are defined. Internal / external analysis facilities (laboratories, comprehensive testing facilities, personnel) & Use of problem solving methods Testing concept for defective parts in the field (standard test/ stress test/ NTF test) And NTF guidelines 96
7.5) Are personnel qualified for the various tasks and are responsibilities defined? Responsibilities, duties and authorisations each employee in Org Chart The employees know the product and the consequences of faulty
workmanship for the supply of parts and the quality of the final product. Failure analysis - Evaluation methods (e.g. audits, statistics) - Quality techniques (e.g. Pareto, 8D Method, cause and effect diagram, Ishikawa) - Foreign language skills
97
Additional risks likely to get discoveredthru’ Turtle Diagram 1. 2. 3. 4. 5. 6. 7.
Quality agreements Agreed inspection & testing procedures. Record of customer visits & deriving measures, Implementation of new requirements Possibilities for plant modification Use of 8 D & verification of effectiveness Customer packing requirements (CSR, Packing Wi),
8. Spare part production plan for after the end of serial production. 9. NTF (No trouble found) guidelines- Procedure 10. Regulations covering replacements -after sales who deal with customer)
98
THANK YOU FOR ATTENDING
