Episode 4: Performance Qualification

Wrapping up our series on Medical Device Process Validation, Josh and Keith discuss the meat of the final step: Performance Qualification.

Show Notes:

  • What is Performance Qualification?
    • GHTF defines as “establishing by objective evidence, that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements ”
    • The OQ established the process parameter ranges, the PQ establishes the entire process – work instructions, operators, shifts, environment, raw materials, etc.
    • Verify as many external factors as possible in a manner commensurate with the product risk
  • Dive into PQ Template
    • Templates are useful, can get Quality and Engineering on the same page, driving consistency in thought and execution
    • First page of the template is boring – validation document number, title, etc.
    • Section 1 – Pre-execution review and approval
      • As noted in our last podcast, pre-approving protocols is critical – otherwise it looks like you move the bar to what passes
      • Could be wet ink signatures or through a change control process
    • Section 2 – Purpose and Scope
      • Give a little background on what the purpose of the PQ is, what the equipment is, etc.
      • Boiler plate that includes the definition of an PQ
      • Consider staying generic to allow re-execution.
    • Section 3 – References
      • References to other applicable SOPs – Process Validation SOP, Statistical Sampling SOP, etc.
      • Reference executed IQ report
      • Reference material / product specifications
    • Section 4 – Definitions
      • Define anything specific to this process or product
    • Section 5 – Responsibilities
      • Consider defining and giving clear expectations to Protocol Executors, that way they know their responsibilities during execution.
    • Section 6 – Signature Identification Block
      • Two purposes:
        • Captures who was responsible for execution of the protocol
        • Covers the training requirement – “signing below indicates you have read and understand the protocol”
    • Section 7 – Deviations
      • Explain how deviations during executions will be handled – have seen a separate page with approvals included in the protocol, also have seen them listed and approved as part of the report
    • Section 8 – Process Description
      • Describe the type of process (injection molding, lamination, assembly, etc)
      • Could include material types, mix ratios, etc
    • Section 9 – Equipment
      • Record the asset or identification number(s) of the pieces of equipment the PQis being executed against
        • Molding Machine & Tool Number
      • Consider putting this in as a table and allowing it to be filled in during execution
        • Can re-execute for multiple tools / machines
        • Specify in report which equipment the PQ was executed against
    • Section 10 – Work Instructions
      • List out the work instructions and forms necessary to execute the process
      • Good control step – timelines get rushed, makes these documents critical path to executing validation
      • Should be released in your quality management system
      • If not, may be attached as draft, but you need to control for any changes prior to release
    • Section 11 – Build Method
      • Really the meat of the PQ, covers three things:
        • Build Strategy & Assumptions
        • Product Material Verification
        • Product Traceability
      • Let’s talk about the build strategy; this is where we discuss all of the requirements for the production run or runs of the PQ, and how we intend to challenge the process:
        • Multiple operators and/or shifts
        • Multiple lots of raw materials
        • Temperature swings
        • For processes where setup/startup are critical, consider forcing multiple startups/shutdowns
        • Conversely, for processes that struggle to maintain stability over long runs, run them a long time
      • Product material verification
        • A control to ensure that we are validating using the correct materials
        • Check the BOM being executed against relevant drawings / specifications
        • Laugh, but I’ve seen a product validated with a different material than listed the drawing – calls into question design controls
      • Product traceability
        • Typically PQ is saleable product, so we document the lot number in our ERP system that ties to all of the materials that were used
    • Section 12 – Sampling Plans
      • Reference your SOP for statistically valid sampling
      • Rationalize non-statistical sampling
      • Tell the executor how and when to sample to get a uniform sampling of each run
        • If you need 60 parts from a 4 cavity tool, going to sample 15 times across the run
      • Include any sample conditioning or soak time required before measurement or testing
        • I.e. polypropylene shrink time – longer dimensions affected more than smaller
    • Section 13 – Acceptance Criteria
      • Acceptance criteria is based on product specifications, functionality, and statistical sampling requirements
      • Typically a table with the Requirement, Test Method, Required Confidence / Reliability, Sample Size, and Pass/Fail Criteria
      • Chosen Confidence / Reliability should relate back to risk documentation like D/PFMEA
    • Section 14 – Attachments
      • List of attachments – objective evidence of output:
        • Laboratory testing pages
        • Material traceability documentation
        • Parameter verification worksheets
      • Consider creating attachments like structured data sheets prior to approval

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