1. Corrective and Preventive Actions
Even More SQA: CAPA
Corrective and Preventive Actions

2. 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

3. Reality Check...
How can we see into the future and fix problems that have not yet occurred?

4. Side Topic Related 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.

5. How to conduct CAPA information collection analysis of information
development of improved methods
implementation of improved methods
follow-up

6. 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

7. 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

8. When do you analyze that huge pile of records?
Answer 1 : After a plane crash.
Answer 2 : Every time a plane lands.

9. Background: Common 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."

10. Control Charts Useful and Very Common Analysis Tool Lines:
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:

11. 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

12. Scatter Charts (example two)
Cyclomatic Complexity v. Module Length

13. 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

14. And, of course, the obvious question
Why bother with CAPA?