19 Key elements

Of
P&G
Quality Assurance 19 KEY elements
1- 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 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
 Clear Communication Of A
Commitment to Quality
- “Right
First time” product
All individual should target producing “Right
First Time” product
- Defines Site’s Quality Strategy and Goals
- Establishes Clear Responsibilities for Quality
- Gaps Identified and Acted on Promptly

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

adequately 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
 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 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 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

Training records are kept

As appropriate personnel have training in special skill
areas such as microbiology, statistics etc.
 Key Element # 3
Building Facilities,
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 space must be provided around and beneath

equipment 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
 What 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 to

produce and/or package the product

• Specifications are defined and tested against to ensure the quality

and safety of the product

• The product meets all regulatory requirements

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

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

finished product

• Master standards are used to evaluate product quality

Key Element # 5
Written Procedures
(SOP)
 What To Check
• Approved procedures covering all appropriate
operations/regulations are current and in place

• Written procedures match actual practice?

• Approved procedures are reviewed regularly

Key Element # 6
Validation
What Needs to Be Validated?
• Products/processes

• Laboratory/testing methods

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

Conditioning)

• Cleaning & sanitization procedures

• Computer systems

• Other critical procedures

 Process Validation
Installation Qualification (IQ)

• Static check that equipment meets design intent

• Equipment properly installed

• Non-reactivity of equipment
 Process Validation
Operational Qualification (OQ)
• Dynamic check that equipment performs as designed

• Equipment capable of operating within limits of

process
 Process Validation
Performance Qualification (PQ)
• Demonstrates that product or process consistently
meets specification

• Demonstrate sustainable performance over time

(example, “Three Batch” criteria)
 Process Validation

Process Validation CQV

IQ + OQ = Commissioning

PQ = Qualification

Centerlining = Verification
 What To Check
• Can our supplier demonstrate consistency in their
processes:

– Making
– Packing
– cleaning & sanitizing

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

 Key Element # 7
Housekeeping, Pest
Control, Sanitization &
Maintenance
 What 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, flaking

paint is evident

• Evidence of effective housekeeping in the facility

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

• Evidence of standing water in & around building

• The warehouse has a neat and orderly appearance

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

identity and corresponding expiration date

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

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

Key Element # 9
Making Operation

Key Element # 10
Packing Operation
 What 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 - Packing

• Employees are properly attired for the

packing operation are following good
hygienic practices

• Appropriate line clearance procedures are in

place and are being followed during the
packing operation

• All packing materials are approved for use

• Lot coding is conducted as part of the

packing operation
 Key Element # 11
Storage & Handling of
Finished Product
 Loading Operations Oil

• Delivery vehicle Inspection

– Vehicles free from:
• Strong odours, Structural damage, Water
Pests , Dirt, water or other
contamination
• Other unauthorised goods or
materials Other materials
• Load Protection
– Standard loading procedures
– FLT driver training
– Void fillers & other devices
– No loose items
– Vehicle not over-loaded
 What To Check
• Approved product is segregated from
product pending and rejected product in
the warehouse

• Procedures are in place to ensure that

approved product is shipped to the
appropriate location

• Approved product is shipped on a FIFO

basis
Key Element # 12
Laboratory Controls
 What To Check
• Equipment is qualified prior to use to ensure that it is
operating within the appropriate ranges

• Equipment is maintained to ensure that it is functioning

properly and prevents product contamination

• Test methods being used are validated or have

demonstrated the ability to produce consistent, reliable
results

• A procedure exists for handling out-of specification

results

• Staff would be competent to perform the analyses

required for the new product
Key Element # 13
Process Controls
PCS Development – 4 M ‘ s Factors
• Machinery’s Centerline

• Materials Variability

• Methods of:
Materials Addition

Analytical Method variability

Start-ups, shut down, re-processes

• People Qualification ( HuMan )

 What To Check
• There is a documented system in place to ensure that
all defined process are not modified or changed
without the appropriate review, notification or re-
qualification where required

• The suppliers demonstrates an understanding of

process control concepts (ex. sampling, data based
centerlines.

• Process documentation is reviewed and updated

periodically to reflect new learning’s or process/design
changes
 Key Element # 14
In-Process & Finished
Product Release &
Control
 What To Check
• A positive release system is in place for
shipping approved product

• There is an out of specification, hold/release

procedure
Key Element # 15
Records
 What 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

Key Element # 16
Self-Improvement
Program
 What To Check
• A regular internal auditing system,
carried out by qualified individuals, is in
place that identifies and corrects any
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 site has a process, utilizing the
appropriate management and technical
resources, to appropriately 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 from the SIP process
Key Element # 19
Accountability for
Contractors
 What To Check
• All sub-contractors used by the contractor to
manufacture finished or semi finished goods
are evaluated and held accountable to the
same standards as the primary contractor
 Thanks..

All the Best