Document ID: F-0112

Title: PERFORMANCE QUALIFICATION PROTOCOL TEMPLATE Revision: A

This document is to be used as a template for generating Performance Qualification (PQ) protocols. As
such, use only the sections that are applicable to the equipment being qualified. Add sections which are
specific for the equipment being qualified, as needed. Use the attachments (report sheets) to report PQ
data and information. They can be amended to create forms that are directly relevant to the
documented activities. Remove all gray sections. “N/A” any section that is not applicable. Fill out the
header section. Remove these instructions.
1. PURPOSE
The purpose of this protocol is to establish a set of uniform steps to complete the performance
qualification (PQ) of the process validation for [Insert Product Name] for [Insert Company Name], in
accordance with the Validation Master Plan (XXXX).

2. PREREQUISITES
2.1. Component criticality assessment performed (prior to or as part of IQ)
2.2. Operational assessment performed (OQ)
2.3. Installation Qualification (IQ)
2.4. Roles and responsibilities should be defined
2.5. Training on PQ activities should be performed and documented
2.6. Validation Plan should be finalized
3. SCOPE
The objective of the Performance Qualification (PQ) is to establish, through documented testing,
that all critical components and equipment are capable of performing within established limits and
tolerances over an extended period of time. This protocol will define the PQ requirements,
specifications and acceptance criteria for the operation of the [Insert Equipment Name, Equip ID],
located at [Insert Company Name], [Insert Company Address].
4. EQUIPMENT DESCRIPTION
Include a detailed description of equipment (e.g., specific components, critical instrumentation,
control/alarm set point, required utilities, etc.) and a statement of the expected operation of the
identified unit. This protocol will cover multiple pieces of equipment that are of a general type (e.g.,
slitter, rewinder, etc.), provide a generic description. In this case, the specific details of the
equipment will be included in the PQ report’s equipment description. The description needs to be
detailed enough to judge the adequacy of the validation sections of the protocol.

 Boyd Technologies, Proprietary

Printed copies are not controlled. Upon receipt of this document, verify it is the current version prior to use.

F-0112-A Page 1 of 3

Tester: ____________________________________ Date: ______________ Verifier:________________________________ Date:___________

 Document ID: F-0112

Title: PERFORMANCE QUALIFICATION PROTOCOL TEMPLATE Revision: A

5. REFERENCES
Document /Form/ Record Document ID Revision
Document Name XXXX Insert Current Rev

6. RESPONSIBILITIES
Designate the equipment owner and those responsible for the protocol generation, protocol
execution, resolving protocol discrepancies, final report generation and approval of all documents.

Role Responsibility

7. TRAINING
Prior to the execution of the protocol, the individual(s) involved in the validation activities must be
trained on the documents listed below. Training is documented per [Insert Company Name]
Standard Operation Procedure, Control of Documents Procedure (XXXX), and Control of Records
Procedure (XXXX), which can be found in the [Document Control System]. Refer to the table below
for training requirements.

Document Document ID Revision

Control of Documents Procedure XXXX Insert Current Rev

Control of Records Procedure XXXX Insert Current Rev

8. MATERIALS
8.1. Material Selection
Provide the sample description, requirements, and limitations for this OQ. Include what
components, assemblies, or devices will be used.
8.2. Sample Size
State the sample size and provide justification. Use the Sample Plan Procedure to determine
the samples size and acceptance and rejection numbers.
9. MANUFACTURING PROCEDURE
9.1. [describe the process step by step]
9.1.1.[substep of the process]
9.1.1.1. [This is any Additional Details or lists associated with this step of the procedure]
9.2. [This is any Additional Details or lists associated with this step of the procedure

 Boyd Technologies, Proprietary

Printed copies are not controlled. Upon receipt of this document, verify it is the current version prior to use.

F-0112-A Page 2 of 3

Tester: ____________________________________ Date: ______________ Verifier:________________________________ Date:___________

 Document ID: F-0112

Title: PERFORMANCE QUALIFICATION PROTOCOL TEMPLATE Revision: A

10. TEST METHOD

Explain what data will be used in the OQ and how it will be evaluated.

11. ACCEPTANCE CRITERIA

Define the acceptable results that must be met for the OQ to be considered successful.

12. DISCREPANCIES / JUSTIFICATION AND CORRECTIVE ACTIONS

List any data that did not meet the acceptance criteria. Include all amendments and deviations. Each
discrepancy must be resolved by justifying a change to the protocol specification or by changing the
item in question to conform to the original specification. All discrepancies must be reviewed and
approved by the appropriate parties.

13. CONCLUSION
This is the summary of the outcome of the protocol.

14. APPENDIX N/A [if this section does not apply]

Appendix 1 – [appendix 1 title]

[Enter description / title of Appendix]

[Include any referenced tables, forms, or figures.]

 Boyd Technologies, Proprietary

Printed copies are not controlled. Upon receipt of this document, verify it is the current version prior to use.

F-0112-A Page 3 of 3

Tester: ____________________________________ Date: ______________ Verifier:________________________________ Date:___________