The Performance Qualification is used to validate a complete integrated process (e.g. a packaging line consisting of several pieces of equipment). Performance Qualification Protocols test the performance and critical parameter testing for each individual piece of equipment on an integrated process. Several test runs are executed for a fixed amount of time on the integrated process. All setup information is documented and samples are collected at the end of the integrated process based on ANSI/ASQC Z1.4-1993 general inspection levels and acceptance quality levels established by the end user. All product criteria and attributes are verified to ensure proper operation of the integrated process to produce the required end product.

As an example a packaging line Performance Qualification is the process that evaluates and documents line performance upon start-up. If a range of container sizes/types are to be run on a line, then the Line PQ will demonstrate line performance for representative container sizes/types. Line PQ is performed after completion of Installation Qualification (IQ) and Operation Qualification (OQ) protocols for the individual units that make up the line. During Line PQ, data are collected concerning critical parameters which could affect package attributes. Equipment is operated at target settings. Line PQ ensures the ability to package the representative container sizes/types in compliance with all procedures and quality standards before saleable product is packaged on the line.

Why produce a PQ?

Performance Qualifications are required in order to ensure that the integrated system being qualified has proven to be operating to acceptable criteria, prior to packaging any saleable product. The IQ and OQ protocols document and test that each individual piece of equipment on an integrated system operates as it was designed. The Performance Qualification tests that each individual piece of equipment on the integrated system are able to operated together in order to achieve the required output on the integrated process. These tests must be performed and proven to pass the acceptable quality levels established for the particular integrated process prior to initiating actual production. Failure to provide proof that the integrated process functions as required results in production delays and high costs in product and components when the integrated process does not operate to acceptable quality levels.

What does a PQ contain?

The Performance Qualification Protocols include (but are not limited to) the following common sections:

Identification of Writer, Approvers, Executors and Revision History: Provides documented evidence on the personnel involved in preparing and executing the protocol complete with samples of signatures, initials and date formats. A revision history is maintained to record any changes to the document and the date they occurred.

Objective, Acceptance Criteria, and Identification of Test Equipment Required:

Defines the intent and limitations of the protocol and specifies the quality critical functions of the equipment. Specifies the criteria for a successful implementation and provides the customer with a list of test equipment to supply.

Equipment/Process Description:

A detailed written description of the entire system is included so as to provide the less-informed reader with the level of information required to gain comprehensive understanding of how the system as a whole is designed to operate.

Listing of Test Run Components:

A complete list of all the test runs that will be performed in the qualification including all the required components, run time for each run, nominal line speed, expected net output, and sampling plans.

P.Q. Testing:

This section will document the actual results from the Performance Testing and will include Equipment Settings, Downtime/Instantaneous Rates, Line Reject Classification, All required line verifications (count accuracy, fill accuracy, bottle attributes, removal torques, label attributes, carton attributes, bundle attributes, etc. - verification will be dependant on product being produced/packaged).

P.Q. Notes, Appendices, and Test Incidents:

These sections are provided to allow for proper documentation of any unforeseen occurrences during protocol execution.

Close Out and Sign Off:

Final approval of the executed document by authorized personnel is required in order to close out the document.