Episode 2: Installation Qualification

In Episode 1, Keith and Josh discussed a general overview of Process Validation. In this Episode, they dive into the first step in Process Validation: Installation Qualification.

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Show Notes:

  • What is Installation Qualification?
    • GHTF defines as “establishing by objective evidence that all key aspects of the
      process equipment and ancillary system installation adhere to the manufacturer’s approved
      specification and that the recommendations of the supplier of the equipment are suitably considered”
    • Long story short: did you install the machine correctly and is it functioning on a basic level
    • Very machine-focused; not really evaluating product at this stage
  • Dive into IQ 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
    • Section 2 – Purpose and Scope
      • Give a little background on what the purpose of the IQ is, what the equipment is, etc.
    • Section 3 – References
      • References to other applicable SOPs – Process Validation SOP, Statistical Sampling SOP, etc.
      • References to Equipment manuals (or include them as attachments)
      • References to previous IQ documents if moving equipment
    • Section 4 – Definitions
    • 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 – Equipment Description
      • Describe the equipment being IQ’ed:
        • Name
        • Asset or Equipment ID
        • Manufacturer
      • Consider making this a generic table if you plan to bring in multiple pieces of the same equipment
    • Section 9 – Environmental, Health, and Safety
      • First instance of a test script – essentially a table with:
        • Requirement
        • Test Procedure – how it is tested
        • Result of Testing – pass/fail or actual value
        • Initials/Date
      • Consider environmental requirements for the machine – temperature, relative humidity
      • Can include safety requirements – lock-out/tag-out procedure posted, warning signs, etc
        • Opportunity, not a requirement in validation
    • Section 10 – Utility Requirements
      • Compressed Air – PSI
      • Voltage
      • Vacuum
      • Ventilation CFM
      • Does this really matter?
        • Worked at a facility where they had to stop running machines on 1st shift because there was not enough air pressure
        • Looks good in an audit, but consider additional controls (regulators, machine stops)
    • Section 11 – Install Equipment
      • Test script for installing the equipment
      • Move machine here, hook up voltage here, hookup air there, check for OSHA space, put safety/ergonomic features in place, etc
    • Section 12 – Calibrated Equipment
      • Verifying all of the gauges and measuring equipment on the machine have current calibrations
      • Reference calibration certificates or consider attaching calibration certificates to the executed protocol
    • Section 13 – Non-Calibrated Equipment
      • Verify any gauges/equipment not critical to quality are identified, rationalized, and labeled “for reference only”
    • Section 14 – Installation Test Script
      • Really the meat of the IQ
      • Test and challenge basic machine functionality – machine startup and shutdown, machine cycles, alarm recovery, utility interruption, safety features like e-stops and light curtains work, etc
      • Software testing – vision system testing, PLC reject tracking, etc.
        • Could consider including statistically-valid testing of these systems
    • Section 15 – Relocation Plan
      • Designate the equipment as mobile or non-mobile
      • What IQ testing do we need to repeat if we were to move this piece of equipment
      • Justify any testing that would not be required
    • Section 16 – Preventative Maintenance
      • List all PM activities as a basis for entry into the PM program
      • Could also attach an approved PM document for the machine
    • Section 17 – Spare Parts
      • Identification of critical spare parts – “will be down for eight weeks if we don’t have this on hand”
    • Section 18 – IQ Equipment
      • Gauges used during the IQ – multi meters, pressure gauges, etc
      • Should have current calibrations
    • Section 19 – Software Backups
      • Section handling machine software control
    • Section 20 – Attachments
      • List of attachments – objective evidence of output,
      • Consider creating attachments like structured data sheets prior to approval

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