Episode 3: Operational Qualification

Writing Operational Qualification (OQ) protocols? In this episode, Keith and Josh walk through elements of an operational qualification protocol template!

Show Notes:

  • What is Operational Qualification?
    • GHTF defines as “establishing by objective evidence process control limits and
      action levels which result in product that meets all predetermined requirements”
    • Where the Installation Qualification was very machine-focused; the OQ is the first look at the process and product
    • Figure out the equipment process ranges and demonstrate that they make good product
  • Dive into OQ 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 episode, 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 OQ is, what the equipment is, etc.
      • Boiler plate that includes the definition of an OQ
      • 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 – Background
      • Give the reviewer history behind why the OQ is being executed – product line changes or moves that initiated the OQ
      • Again, consider staying pretty generic if it is possible to re-execute this protocol
    • Section 9 – Process Description
      • Describe the type of process (injection molding, lamination, assembly, etc)
      • Could include material types, mix ratios, etc
    • Section 10 – Equipment and Material Traceability
      • Record the asset or identification number(s) of the pieces of equipment the OQ is 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 OQ was executed against
      • Record materials used for traceability
        • Can reference raw material part numbers and lots
        • Can reference a production order from your ERP system
          • Be careful if you use a production order; may need to implement a process to confirm the material is placed in a hold status to prevent release
    • Section 11 – Build Method
      • Really the meat of the OQ, covers three things:
        • Process Characterization
        • Justification for chosen critical process parameters
        • LImit Testing of critical process parameters
      • Process characterization is used to establish the critical parameters and operating ranges for those parameters
        • Can be done separately as an Engineering Study / Formal Information Collection and then attached to the OQ
        • Can be done as part of the OQ
        • Can use different strategies
          • Design of Experiments or DOE
          • Taking the process to failure on lower and upper ranges
      • Process characterization should provide justification for the critical parameters, and become an input to limit testing
      • Limit testing is where you test the lower and upper parameter ranges in separate runs
        • Parameters, ranges, and justifications for criticality can be a table
        • Describe how to execute both of these runs
        • Time / number of parts to be produced as part of each run
    • 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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