Performance Qualification (PQ) at Putnam Plastics

• This document establishes a method for Performance Qualification (PQ) activities at Putnam Plastics Corporation (PPC).
• This work instruction is applicable to products/processes approved by PPC management or under contractual validation requirements.
• The document describes the PQ protocol and report contents, review requirements, and execution method.

Responsibilities

• Senior Management ensures resources are available for validation activities.
• A Validation Manager coordinates all aspects of validation activities.
• Protocol generation, report generation, and document approval routing are all elements of the validation activities that the validation manager is in charge of coordinating
• The Validation Manager is responsible for communicating validation progress and deviations to the customer.
• The New Product Development Engineer defines parameters to be challenged during qualification and supports validation efforts.
• The Quality Engineer inspects validation samples and creates the protocol and report, also supporting validation efforts.

Reference Documents and Forms

• Statistical Techniques for Inspection/Sampling (DMS# 2605)
• Control of Documents (DMS# 1006)
• Control of Records (DMS# 1005)
• Change Control Order / Document Change Process (DMS# 1027)
• Validation Procedure (DMS# 1133)
• Installation Qualification Work Instruction (DMS# 1131)
• Operational Qualification Work Instruction (DMS# 1135)
• Performance Qualification Protocol Template (DMS# 1232)
• Performance Qualification Report Template (DMS# 1233)
• Product Realization Work Instruction (DMS# 1563)

Definitions

• DMS: Document Management System
• MVP: Master Validation Plan

Safety Precautions

• It is important to follow safety precautions during validation work on or near equipment and machinery.

General Procedure

• Performance Qualification (PQ) challenges critical process parameters under nominal conditions, replicating typical production environment.
• Challenge conditions are recommended to represent the typical production environment.
• An example of challenge condition is the 'Nominal Condition' under a cutting process where line speed and encoder-to-drive wheel gap are critical.
• PQ is conducted for products/processes approved for validation by the management team, which usually happens after an operational qualification (OQ). However, a completed OQ is not always a prerequisite for PQ execution, but the PQ shall be conducted per the approved Master Validation Plan (MVP).
• PQ activities are conducted per an approved validation plan or customer qualification document.
• PQ protocols are controlled via the Putnam Plastics Document Management System (DMS).
• Statistical analysis and inspection techniques are used to collect and analyze data, with alternative methods documented in the protocol.
• PQ training forms, quality inspection forms, memoranda, printed test reports, and other supporting evidence of activities are records controlled per Control of Records (DMS# 1005).

Protocol Generation & Content

• Using the PQ Protocol Template (DMS# 1232) is preferred, but a customer's or vendor's template may be used.
• The PQ Protocol must include: Purpose, Scope, Responsibilities, Reference Documents, Definitions, Safety Precautions, Training Requirements, Process parameters with rationale, Procedure, and Sampling Plan.
• Additional sections like validation flow charts or OQ results can be included.

Protocol Review & Approval

• The protocol is reviewed by product/process stakeholders for content and alignment with obligations/expectations.
• Approvals/rejections follow Control of Documents (DMS# 1006) and CCO Process (DMS# 1027).
• The customer may sign the protocol using DMS# 1232 signature block, attaching approval in DMS using the "paperclip" function.
• Revisions/deviations are handled through the CCO Procedure (DMS# 1027), with customer agreement (if applicable) and documentation in the qualification report.

Training

• Participants in the protocol's execution are to be trained on activities they will be performing

Protocol Execution

• Execution requires formal protocol approval through DMS and fulfillment of prerequisite requirements like Installation Qualification (IQ).
• "DRAFT" versions of process documentation may be used during PQ protocol execution and must be attached to the lot history record and PQ report.

Report Generation & Content

• Reports must include: Purpose, Scope, Reference Documents, Training, Process Summary, Inspection Results & Data Analysis, Deviations, and Conclusion.

Report Review & Approval

• The report is reviewed for content by stakeholders, ensuring fulfillment of contractual obligations/expectations and is approved/rejected per Control of Records (DMS# 1005).
• If applicable, the customer may sign the report using the signature block of the PQ Report Template (DMS# 1233), attaching approval in DMS using the "paperclip" function.
• Upon completion, the product/process may move forward through product realization (DMS# 1563) or onto the next phase in the MVP.

General Performance Qualification Process

• The general process involves: approving the PQ protocol, manufacturing PQ units, finishing PQ units, inspecting PQ units, following NC process (if necessary,) shipping PQ units, customer review & approval of the PQ Report, and then proceeding to the next step per the MVP.