19 Key elements P&G
Quality Assurance 19 KEY elements 1- Leadership
2- Training 3-Building facilities, equipment Design and installations 4-Technical 4-Technical Standards 5-Written procedures 6-Validation 7-Housekeeping, Pest control Sanitization & Maintenance 8- Materials 9-Making operations - ac ng ope pera ra ons ons 11-Storage & Handling of Finished products 12-Laboratory Control 13-Process Control 14-In process & Finished Product Release & control 15-Records 16-Self improvement program 17-Consumer & Customer Learning & Response 18-Quality system Results tracking and improvement 19-Accountability 19-Accountability for contractors
Key Element # Leadership
1
Clear Communication Communication Of A Commitment to Quality “Right First time” product All individual should target producing “Right First Time” product - Defines Site’s Qualit Strate and Goals - Establishes Establishes Clear Clear Respon Responsibili sibilities ties for for Quality Quality - Gaps Iden Identif tified ied and and Acted Acted on Prompt Promptly ly
Organizational Design & Capability Recognition Of Quality Contributions
What To Check • The performance behavior of leadership demonstrates a commitment to quality Leadership ensures quality responsibilities are • Leadership
• Is there a quality improvement process? Does management play a role in this effort?
Key Element # Training
2
Why is Training & why it is Important? It is combination c ombination of Education, Training and Practical experience. To ensure individuals are capable of doing the job Part of Continual Improvement To help individual improve and progress through the organisation To reduce error and rework To promote efficient operations To build capability within the organisation
What To Check
All employees have received sufficient training (including QAKE) to perform their assigned functions Employees are qualified for their particular job function (including written written test or on the job assessment) All employees have received training in contamination prevention prevention (i.e., proper handling of product) There is a system to ensure new employees are informed of responsibilities and expectations expectations Training records are kept As appropriate personnel have have training in special skill areas such as microbiology, statistics etc.
Key Element #
3
u ng ac es, Equipment Design & Installation
What To Check • The facility does not have design flaws that lend itself to contamination
• Facilities are adequate lit, ventilated for the work being done
• Sufficient s ace must be rovided around and beneath equipment to facilitate proper operation, maintenance, clea cleani ning ng,, sani saniti tizzat atio ion n and and prev preven entt mixmix-up upss
• Facilities designed to handle micro susceptible products (ex. (ex. water ter, pack packin ing g line line equi equipm pmen entt
Key Element #
4
Technical Standards
What To Check •
Procedures are in place to ensure that only current, approve spec specif ific ica ation tionss and and standa andarrds are are bein being g used used
•
Approved, current formula cards & specifications are being used to prod produc uce e and/ and/or or pack packag age e the the prod produc uctt
•
Specifications are defined and tested against to ensure the quality and safety of the product
•
The roduct meets all re ulator re uirements
•
Valida lidatted test est methods hods are are bei being used used to evalua aluatte raw mat materia erials ls,, bul bulk and and fini finish shed ed prod produc uctt
•
Stability testing has been conducted to support the stability of the finish finished ed produ product ct
•
Masster standa Ma andarrds are are used used to eval evalua uatte prod produc uctt qual qualit ity y
Key Element #
(SOP)
5
What To Check • Appr Approv oved ed proce procedu dure res s cover coverin ing g all all ap appr prop opri riat ate e operations/regulations are current and in place • Writte Written n procedures procedures match actual practice? practice? • Approved Approved procedures procedures are reviewed reviewed regularly regularly
Key Element # Validation
6
What Needs to Be Validated? • Produ Product cts/ s/pro proces cesse ses s • Laborato Laboratory/ ry/test testing ing methods methods • Storage conditions conditions (e.g. HV HVAC AC - Heating, Ventilating, Air
• Cleanin Cleaning g & sanitiz sanitizati ation on procedur procedures es • Co Compu mputer ter syst system ems s • Other Other critic critical al procedur procedures es
Process Validation
Installation Qualification Qualification (IQ) • Static check that equipment meets design intent • Equipmen Equipmentt properl properly y install installed ed • Non-reac Non-reactiv tivity ity of equipmen equipmentt
Process Validation
Operational Qualification (OQ) Operational • Dynamic Dynamic check that equipment performs as designed • Equipment Equipment capable of operating within limits limits of process
Process Validation
Performance Qualification Qualification (PQ) • Demo Demons nstr trat ates es th that at prod produc uctt or proc proces ess s cons consis iste tent ntlly meets specification • Dem emon ons strat ate e susta taiinab ablle pe perrform orman anc ce over time ime (example, (example, “Three Batch” criteria) criteria)
Process Validation
Process Validation
CQV
IQ + OQ
=
Commissioning
PQ
=
Qualification
Centerlining
=
Verification
What To Check demonstrate consistency in their • Can our supplier demonstrate processes:
– Making – Packing – c ean ng
san t z ng
• Is there a validation process that does IQ,OQ, PQ
Key Element #
7
ouse eep ng, es Control, Sanitization & Maintenance
What To Check •
Evide videnc nce e of eff effecti ective ve pes pest cont contrrol proc proced edur ures es videnc nce e of inf infest estation tion – No evide Electr troc ocut uter erss in plac place e – Elec – Roden odentt trap trapss visi visibl ble e
•
Evidence of leaky walls, roofs or ceilings exist or nor chipping, flaking pain paintt is evide viden nt
•
Evide videnc nce e of eff effecti ectiv ve hous housek ekee eepi ping ng in the the facil acilit ity y
•
Exterior doors (including dock doors) are closed when not in use, or inse nsect scre creens ens are use used to pro protect ect ope opening ningss
•
Evidence of standing water in & around building
•
The wareh arehou ousse has has a nea neat and orde orderl rly y appe appear aran ance ce
Key Element #
8
Starting Materials
What To Check •
Starting materials are correctly labeled by our supplier as per specifications
•
Materials have a unique number and are clearly labeled as to their iden identi tity ty and and corr corres espo pond ndin ing g expir xpirat atio ion n dat date
•
The site has a positive release system for all materials before they are used
•
e s e as a sys em e m or materials
•
All starting materials are properly stored, off the floor and away from walls
•
The site uses a First In, First Out (FIFO) system for material distribution and use
•
All materials in the making operation are approved for use
e appropr a e s or o rage an
spos on o
Key Element #
9
Making Operation Key Element # Packing Operation
What Wh at To Ch Check eck - Ma Maki king ng •
Employees are properly attired for the making operation and are demonstrating good hygienic practices
•
All equipment in the making process is properly designed for its intended use.
•
Appropriate line clearance procedures are in place during the making operation
•
The making operation is being conducted in accordance with an approved formula card
•
The site has written cleaning & sanitizing procedures for its equipment
•
Cleaning agents are safe and do not enter the product stream.
What Wh at To Ch Chec eck k - Pa Pack ckin ing g • Employees are properly attired for the packing operation are following good hygienic practices • Approp Appropriat riate e line clear clearance ance proced procedures ures are are in lace and are bein followed durin the packing operation • All packing materials materials are approved approved for use • Lot coding is conducted as part of the packing operation
Key Element #
11
orage an ng o Finished Product
Loading Operations • Delive Delivery ry vehicle vehicle Inspecti Inspection on – Vehicles free from: • Strong odours, odours, Structural Structural damage, Pests , Dirt, water or other contamination • O th e r unauthorised goods or materials • Load Load Prote Protecti ction on – Standard loading loading procedures procedures – FLT FLT driver training – Void fillers & other devices – No loose loose items – Vehicle not over-loaded
Oil
Water
What To Check • Approved ved product is seg segreg regated from rom product pending and rejected product in the warehouse • Procedures are in place to ensure that approve pro uct s s ppe to t e appropriate location • Approve Approved d product product is shippe shipped d on a FIFO FIFO basis
Key Element #
12
Laboratory Controls
What To Check • Equi Equipm pmen entt is quali qualifie fied d prior prior to use use to ensu ensure re that that it is operating within the appropriate ranges • Equipmen Equipmentt is maintaine maintained d to ensure ensure that that it is funct functioning ioning properly and prevents product contamination contamination •
demonstrated the ability to produce consistent, reliable results
• A proce roced dure ure exists ists for handlin dling g out-o t-of specif ecific ica atio tion results • Sta tafff would be compete ten nt to perfo rform the analyses required for the new product
Key Element #
13
Process Controls
PCS PC S De Devel velop opme ment nt – 4 M ‘ s Fac Factor torss •
Machinery’s
•
Materials
•
Methods
Centerline
Variability
of: a er a s
on
Analytical Method variability Start-ups, shut down, re-processes •
Peop People le Qual Qualif ific icat atio ion n ( HuMan )
What To Check • There There is is a docum documented ented system system in in place place to ensure ensure that that all defined process are not modified or changed without th the e appropriate iate review, notific ficatio tion or requalification where required • The suppliers demonstrates an understanding of process con con ro concep s ex. samp ng, a a ase centerlines. • Process documentation is reviewed and updated periodically to reflect new learning’s or process/design changes
Key Element #
14
Product Release & Control
What To Check • A positive release system is in place for shipping approved product procedure
,
Key Element # Records
15
What To Check •
Cleaning & Sanitizing records are available to demonstrate cleaning & sanitizing of equipment and for traceability for problem solving
•
Making Making & p packi acking ng M Master aster Productio Production n Records Records are kept for each lot of product produced to ensure traceability and reproducibility of the batch
•
Records are maintained documenting documenting testing conducted on the product and corresponding corresponding results to support the approval and release r elease of the product
•
Out-of-specification Out-of-specification investigations investigations and deviations to the making and packing operations are appropriately documented.
•
Consumer complaint investigations investigations are appropriately documented
•
Records Records are kept on all receipts receipts and usage usage of material materials s
•
Records Records of maintenan maintenance ce and and calibrati calibration on operation operations s are are docum documente ented d
Key Element #
16
Self-Improvement Program
What To Check • A regular internal auditing system, carried out by qualified individuals, is in place lace th that at iden identi tifi fies es and corr corre ects cts an any y deficiencies present in the site’s quality systems and causes • permanent systemic solutions to be implemented
Key Element #
17
Consumer & Customer Learning & Response
What To Check • The The site has a process, utilizing the appropriate management and technical resources
to a
ro riatel
receive
investigate, document, and follow-up on customer and consumer complaints
Key Element #
18
Quality System Results Tracking & Improvement
What To Check • A system exists to define and/or track critical quality measures • A system exists to monitor results and progress rom e process
Key Element #
19
Accountability for Contractors
What To Check • All sub-co sub-contr ntract actors ors used used by the contrac contractor tor to manufacture finished or semi finished goods are evaluated and held accountable to the same standards as the primary contractor
Thanks..
All the Best
