Navigating CAPA

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					PDA-FDA Conference, September 2003




  Navigating CAPA

                 Paula J. Shadle, Ph.D.
                   Shadle Consulting


                      Shadle Consulting   1
    Outline

•   Why is it so difficult to do effective CAPA?

• How many resources are enough?

• Case Studies of CAPAs

• Practical Advice and Metrics Use
                                               2
CAPA in the Real World

 Conflicts with today‟s production run
 Important, but not urgent
 Accumulating commitment over time
 “Overhead” and not cheap
 Experience required
 Usually not resourced to do CAPA

                                      3
Why Do It, Then?

 Costs more to have recurrent non-
  conformances
   – Regulatory risk
   – Business risk
 It‟s good science
 Cheaper in the long run


                                      4
Examples from Various Industries
 Ford Pinto
 Firestone tires
 Tylenol poisonings
 HIV entry into the blood supply
Lessons learned: Intervene aggressively
  and early, or suffer costly litigation,
  preventable mortality, and loss of your
  market share

                                            5
Situation really calls for multiple, iterative CAPA

  Case Study #1
     High rate of invalid test results in the
      raw materials QC testing laboratory
       – Up to 70% OOS observations are
         later invalidated
       – Impact: cycle time for raw material
         release is 3 times theoretical
         • Cost of $MM in stocking extra
           inventory to cover
         • Low productivity in QC lab
                                                  6
    Too many invalid tests

Example of Deviations
   PROCEDURE NOT FOLLOWED
    – Analyst failed to incubate for 45 mins
    – Analyst incubated at 35 C instead of 37 C
    – Analyst checked his own calculations
Rare:
    – Method not capable
    – Instrument not capable (1%/0.1%)
    – True non-conforming material
                                                  7
Investigation
   Training and supervision
    – Over 50% < 6 months in the job
   Method, instrument capability
    – Calibration range wider than operational
      requirement
    – Lack of automation
   Breadth, range, and frequency
    – Tests done infrequently; many types
   Perceptions
    – USP, easy, no training needed              8
Results: Rate dropped to <10% in one year; Cycle time cut in half


  CAPA Actions Taken
     Re-trained supervisor,
      – Added second shift oversight
      – QA support on the floor
     Increase employee retention
      – Re-defined jobs and expertise (Level)
          • Increased training
          • Checked proficiency regularly
      – Tracked invalid test rates and aggressively
        investigated all invalids.
          • Applied solutions to the entire work unit, not just the
            analyst involved in each event
                                                                  9
Experience: The Flip Side

   Not following procedure
    – Highly trained, experienced people
      • Innovating without updating SOPs
      • May be unconscious
    – Increase QA presence in the lab
      • Train supervisors to self-audit
      • Redline SOP while watching


                                           10
Process Shift/Trend Not Noticed

   Roots:
    – Equipment change not controlled
      properly
    – Spec set too wide
    – Staff not trained to spot trends
    – CA: Explain the process shift
      • Adjust to bring back to baseline
    – PA: Narrow action limit
                                           11
Case Study at AnyFirm, Inc.

Inheriting CAPA Backlog

   “Welcome to Firm, Inc. You are
    responsible for 700 late CAPAs.
    Better get them closed !!”
    – Symptoms of a problem
    – What might the real problem be?
    – What to do first?
    – What risk do you have in the meantime?
                                           12
Some Hints for Backlogs
   Investigate the root cause of the backlog
    – Take action to address the root cause AND
    – Address the backlog aggressively
       • Make CAPA a priority for the work unit
          – Dedicate some people to CAPA only
       • Prioritize and re-negotiate due dates
          Find some stupid minor ones and close them
          Assess the relative risks if not corrected
       • Put one person in charge of CAPAs
          – Nag, request resources, follow up

                                                       13
Potential Causes

   Lack of ownership
    – No accountability or reward
    – Who controls it?
   Proposed actions are meaningless
    – Evaluate and re-negotiate. Who judges?
   Process is not capable
    – Get Development working on solutions
   Serious under-staffing
                                               14
Advice: Minimize Risks

   Inform management of the risks
    – Business; Compliance; patient
    – Integrated solutions across departments
    – Close the critical items on time
 Approach FDA early, if you can‟t
  meet commitments made
 Collect metrics and use them
    – Showing improvement is very helpful
    – Set and meet goals and timelines
                                                15
    Example: Relative Risks
 Repeat bioburden excursions on the WFI
  system
 Repeat bioburden excursions in the filling suite
 Repeat bioburden excursions in cleaning
  validation samples
 Justify    your priorities!
    – Fix the fill suite first
    – Then the water system
    – Compensate by increased monitoring of WFI
      and cleaning                          16
Incidence, Backlog, and Quality of CAPAs

   Collect Useful Metrics
    Incidence of new non-conformances
    New CAPA/closing CAPA/net open
        – Monitor the Backlog
      Frequency of repeat events
                                            CAPA Types
Before/After
                                 first         High
                                               Med
    1
                                   repeat
        2        open                          Low
                                                17
    NEW
Results Reporting

 New NCM rate reduced 20% after < >
 Recurrence rate dropped 33%*
 Average CAPA cycle time
    – Time to close critical CAPA
    – Time to close average CAPA
   What do these data mean? Check
      • Priorities, resources, & effectiveness

                                                 18
    CAPA-Phobias

 Will my CAPAs be a road map to a 483?
 It‟s bad to have too many, so I will do
  some „off-the-record‟
 All CAPAs must close on-time, or else
 My tracking system isn‟t part 11
  compliant, so I will dump it
 CAPA costs too much

                                       19
Acknowledgements

 Cindy Rockel, Millipore Corporation

 Brenda Dukeshire, Millipore Corporation




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