Even More SQA: CAPA

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Even More SQACAPA

• Corrective and Preventive Actions

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What is CAPA?

• activities not intended to correct defects, but
  to eliminate the cause of those defects.
• corrective - fix past problems
• preventive - predict potential problems

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Reality Check...

• How can we see into the future and fix problems
  that have not yet occurred?

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Side TopicRelated to CAPA PDCA

• PLAN 
• Establish the objectives and processes necessary
  to deliver results in accordance with the
  specifications.
• DO 
• Implement the processes.
• CHECK 
• Monitor and evaluate the processes and results
  against objectives and specifications and report
  the outcome.
• ACT 
• Apply actions to the outcome for necessary
  improvement. This means reviewing all steps
  (Plan, Do, Check, Act) and modifying the process
  to improve it before its next implementation.

http//en.wikipedia.org/wiki/Plan_Do_Check_Act
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How to conduct CAPA

• information collection
• analysis of information
• development of improved methods
• implementation of improved methods
• follow-up

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What info gets analyzed?

• Roundup the usual suspects
• design review reports
• code walkthrough reports
• test reports
• project progress reports
• customer complaint records
• software change requests and maintenance reports
• training follow-up reports
• But don't forget
• special reports on quality / quality audits
• suggestions / observations by staff

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Ways to sift through that huge pile of records

• asks the reporter to indicate a priority for
  their report
• random sampling
• combination of the two techniques above

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When do you analyze that huge pile of records?

• Answer 1 After a plane crash.
• Answer 2 Every time a plane lands.

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BackgroundCommon Cause and Special Cause

• " 'A riot occurs in a certain prison. Officials
  and sociologists turn out a detailed report about
  the prison, with a full explanation of why and
  how it happened here, ignoring the fact that the
  causes were common to a majority of prisons, and
  that the riot could have happened anywhere.'
• The quote recognizes that there is a temptation
  to react to an extreme outcome and to see it as
  significant, even where its causes are common to
  many situations and the distinctive circumstances
  surrounding its occurrence, the results of mere
  chance. Such behavior has many implications
  within management, often leading to interventions
  in processes that merely increase the level of
  variation and frequency of undesirable outcomes."

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Control Charts

• Useful and Very Common Analysis Tool
• detect and predict problems in the process
• Lines
• Center Line mean
• Upper and Lower Control Limits (UCL and LCL)
• typically 4 standard errors
• Warning Limits
• typically 3 standard errors
• If the process is "in control", all points will
  plot within the control limits.

adapted from http//en.wikipedia.org/wiki/Contro
l_chart
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Scatter Charts (example one)

• Eruptions generally fall into two categories
• short wait, short duration
• long wait, long duration
• Hence, some simple data
• analysis yields insights
• into this process.

stolen from http//en.wikipedia.org/wiki/Scatter_d
iagram
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Scatter Charts (example two)

• Cyclomatic Complexity v. Module Length

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CAPA Outcome Improved Methods

• updating processes
• updating relevant work procedures
• changing tools
• improvement of reporting methods
• report contents
• report frequency
• changes in training
• probably, several of the above

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And, of course, the obvious question

• Why bother with CAPA?