19 Elements of P&G Audit Dt15!1!10

19 Key elements Of

19 Key elements OfOfP&GOfP&G

Quality Assurance 19 KEY elementsQuality Assurance 19 KEY elements1- Leadership

2- Training

3-Building facilities, equipment Design and installations

4-Technical Standards

5-Written procedures

6-Validation

7-Housekeeping, Pest control Sanitization & Maintenance

8- Materials

9-Making operations

10-Packing operations10-Packing operations

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 for contractors

Key Element # 1

Leadership

Key Element # 1

LeadershipLeadershipLeadership

-

All individual should target producing “Right First Time” product

- Defines Site’s Quality Strategy and Goals

Clear Communication Of A Commitment to Quality “Right

First time” product

Clear Communication Of A Commitment to Quality “Right

First time” product

- Defines Site’s Quality Strategy and Goals- Establishes Clear Responsibilities for Quality- Gaps Identified and Acted on Promptly

Organizational Design & CapabilityOrganizational Design & Capability

Recognition Of Quality ContributionsRecognition Of Quality Contributions

What To CheckWhat To Check

• The performance behavior of leadership

demonstrates a commitment to quality

• Leadership ensures quality responsibilities are

adequately staffed for all areas of the businessadequately staffed for all areas of the business

• Is there a quality improvement process? Does

management play a role in this effort?

Key Element # 2

Training

Key Element # 2

TrainingTrainingTraining

Why is Training & why it is Important?

Why is Training & why it is Important?

It is combination 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 help individual improve and progress through the organisation

� To reduce error and rework

� To promote efficient operations

� To build capability within the organisation


� All employees have received sufficient training (including QAKE) to perform their assigned functions

� Employees are qualified for their particular job function (including written test or on the job assessment)

� All employees have received training in contamination prevention (i.e., proper handling of product)

� There is a system to ensure new employees are informed of responsibilities and expectations

� There is a system to ensure new employees are informed of responsibilities and expectations

� Training records are kept

� As appropriate personnel have training in special skill areas such as microbiology, statistics etc.

Key Element # 3

Building Facilities,

Key Element # 3

Building Facilities, Building Facilities, Equipment Design &

Installation

Building Facilities, Equipment Design &

Installation

What To CheckWhat To Check• The facility does not have design flaws that lend itself to

contamination

• Facilities are adequate lit, ventilated for the work beingdone

• Sufficient space must be provided around and beneath• Sufficient space must be provided around and beneathequipment to facilitate proper operation, maintenance,cleaning, sanitization and prevent mix-ups

• Facilities designed to handle micro susceptible products(ex. water, packing line equipment

Key Element # 4

Technical Standards

Key Element # 4

Technical StandardsTechnical StandardsTechnical Standards

What To CheckWhat To Check• Procedures are in place to ensure that only current, approve

specifications and standards are being used

• Approved, current formula cards & specifications are being used toproduce and/or package the product

• Specifications are defined and tested against to ensure the qualityand safety of the product

• The product meets all regulatory requirements• The product meets all regulatory requirements

• Validated test methods are being used to evaluate raw materials, bulkand finished product

• Stability testing has been conducted to support the stability of thefinished product

• Master standards are used to evaluate product quality

Key Element # 5

Written Procedures

Key Element # 5

Written Procedures Written Procedures (SOP)

Written Procedures (SOP)


• Approved procedures covering all appropriateoperations/regulations are current and in place

• Written procedures match actual practice?

• Approved procedures are reviewed regularly

Key Element # 6Key Element # 6

ValidationValidation

What Needs to Be Validated?What Needs to Be Validated?• Products/processes

• Laboratory/testing methods

• Storage conditions (e.g. HVAC - Heating, Ventilating, Air

Conditioning)Conditioning)

• Cleaning & sanitization procedures

• Computer systems

• Other critical procedures

Process Validation

Installation Installation Qualification (IQ)Qualification (IQ)Process Validation

Installation Installation Qualification (IQ)Qualification (IQ)

• Static check that equipment meets design intent

• Equipment properly installed

• Non-reactivity of equipment

Process Validation

Operational Operational Qualification (OQ)Qualification (OQ)Process Validation

Operational Operational Qualification (OQ)Qualification (OQ)

• Dynamic check that equipment performs as designed

• Equipment capable of operating within limits of

processprocess

Process Validation

Performance Qualification (PQ)Performance Qualification (PQ)Process Validation

Performance Qualification (PQ)Performance Qualification (PQ)

• Demonstrates that product or process consistently

meets specification

• Demonstrate sustainable performance over time

(example, “Three Batch” criteria)

Process ValidationProcess Validation CQVCQV

IQ + OQ = Commissioning

PQ = Qualification

Process ValidationProcess Validation

PQ = Qualification

Centerlining = Verification


• Can our supplier demonstrate consistency in their processes:

– Making

– Packing

– cleaning & sanitizing – cleaning & sanitizing

• Is there a validation process that does IQ,OQ, PQ

Key Element # 7

Housekeeping, Pest

Key Element # 7

Housekeeping, Pest Housekeeping, Pest Control, Sanitization &

Maintenance

Housekeeping, Pest Control, Sanitization &

Maintenance

What To CheckWhat To Check• Evidence of effective pest control procedures

– No evidence of infestation

– Electrocuters in place

– Rodent traps visible

• Evidence of leaky walls, roofs or ceilings exist or nor chipping, flakingpaint is evident

• Evidence of effective housekeeping in the facility

• Exterior doors (including dock doors) are closed when not in use, orinsect screens are used to protect openings

• Evidence of standing water in & around building

• The warehouse has a neat and orderly appearance


Starting MaterialsStarting Materials

What To CheckWhat To Check• Starting materials are correctly labeled by our supplier as per

specifications

• Materials have a unique number and are clearly labeled as to theiridentity and corresponding expiration date

• The site has a positive release system for all materials before they areused

• The site has a system for the appropriate storage and disposition of• The site has a system for the appropriate storage and disposition ofmaterials

• All starting materials are properly stored, off the floor and away fromwalls

• The site uses a First In, First Out (FIFO) system for material distributionand use

• All materials in the making operation are approved for use

Key Element # 9Making Operation

Key Element # 9Making Operation

1010Key Element # 10Packing Operation

Key Element # 10Packing Operation

What To Check - MakingWhat To Check - Making

• 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 To Check - PackingWhat To Check - Packing

• Employees are properly attired for thepacking operation are following goodhygienic practices

• Appropriate line clearance procedures are inplace and are being followed during thepacking operationplace and are being followed during thepacking operation

• All packing materials are approved for use

• Lot coding is conducted as part of thepacking operation

Key Element # 11

Storage & Handling of

Key Element # 11

Storage & Handling of Storage & Handling of Finished Product

Storage & Handling of Finished Product

Loading OperationsLoading Operations• Delivery vehicle Inspection

– Vehicles free from:

• Strong odours, Structural damage,

Pests , Dirt, water or other

contamination

• Other unauthorised goods ormaterials

Oil

Water

Other materials

• Load Protection

– Standard loading procedures

– FLT driver training

– Void fillers & other devices

– No loose items

– Vehicle not over-loaded

Other materials


• Approved product is segregated fromproduct pending and rejected product inthe warehouse

• Procedures are in place to ensure thatapproved product is shipped to theapproved product is shipped to theappropriate location

• Approved product is shipped on a FIFObasis

Key Element # 12

Laboratory Controls

Key Element # 12

Laboratory ControlsLaboratory ControlsLaboratory Controls


• Equipment is qualified prior to use to ensure that it isoperating within the appropriate ranges

• Equipment is maintained to ensure that it is functioningproperly and prevents product contamination

• Test methods being used are validated or have• Test methods being used are validated or havedemonstrated the ability to produce consistent, reliableresults

• A procedure exists for handling out-of specificationresults

• Staff would be competent to perform the analysesrequired for the new product


Process ControlsProcess Controls

PCS Development – 4 M ‘ s Factors PCS Development – 4 M ‘ s Factors

• Machinery’s Centerline

• Materials Variability

• Methods of:

Materials AdditionMaterials Addition

Analytical Method variability

Start-ups, shut down, re-processes

• People Qualification ( HuMan )


• There is a documented system in place to ensure thatall defined process are not modified or changedwithout the appropriate review, notification or re-qualification where required

• The suppliers demonstrates an understanding ofprocess control concepts (ex. sampling, data basedprocess control concepts (ex. sampling, data basedcenterlines.

• Process documentation is reviewed and updatedperiodically to reflect new learning’s or process/designchanges

Key Element # 14

In-Process & Finished

Key Element # 14

In-Process & Finished In-Process & Finished Product Release &

Control

In-Process & Finished Product Release &

Control


• A positive release system is in place forshipping approved product

• There is an out of specification, hold/release• There is an out of specification, hold/releaseprocedure


RecordsRecords

What To CheckWhat To Check• Cleaning & Sanitizing records are available to demonstrate cleaning &

sanitizing of equipment and for traceability for problem solving

• Making & packing Master Production Records are kept for each lot of product produced to ensure traceability and reproducibility of the batch

• Records are maintained documenting testing conducted on the product and corresponding results to support the approval and release of the product

• Out-of-specification investigations and deviations to the making and packing operations are appropriately documented.

• Consumer complaint investigations are appropriately documented

• Records are kept on all receipts and usage of materials

• Records of maintenance and calibration operations are documented


Self-Improvement Program

Self-Improvement Program


• A regular internal auditing system,carried out by qualified individuals, is inplace that identifies and corrects anydeficiencies present in the site’s qualitysystems and causessystems and causes

• permanent systemic solutions to beimplemented

Key Element # 17

Consumer & Customer

Key Element # 17

Consumer & Customer Consumer & Customer Learning & ResponseConsumer & Customer Learning & Response


• The site has a process, utilizing the

appropriate management and technical

resources, to appropriately receive,resources, to appropriately receive,

investigate, document, and follow-up on

customer and consumer complaints

Key Element # 18

Quality System

Key Element # 18

Quality System Quality System Results Tracking &

Improvement

Quality System Results Tracking &

Improvement


• A system exists to define and/or trackcritical quality measures

• A system exists to monitor results andprogress from the SIP processprogress from the SIP process

Key Element # 19

Accountability for

Key Element # 19

Accountability for Accountability for Contractors

Accountability for Contractors

What To CheckWhat To Check• All sub-contractors used by the contractor to

manufacture finished or semi finished goodsare evaluated and held accountable to thesame standards as the primary contractor

Thanks..Thanks..

All the BestAll the Best

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19 Elements of P&G Audit Dt15!1!10