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 # Leadership

1

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 # Training

2

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 # Validation

6

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
IQ + OQ PQ Centerlining = = =

CQV

Commissioning Qualification 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 10

Making Operation Key Element #

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
• Delivery vehicle Inspection – Vehicles free from: • Strong odours, Structural damage, Pests , Dirt, water or other contamination • Other unauthorised goods or materials • Load Protection – Standard loading procedures – FLT driver training – Void fillers & other devices – No loose items – Vehicle not over-loaded

Oil

Water

Other materials

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 requalification 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 # Records

15

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

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