- Dear Ambika,<?xml:namespace prefix = o ns =
"urn:schemas-microsoft-com:office:office" />
- The reasons for documenting deviations are:-
- · Determine the root
cause of the problem and fix it
- · Determine the
consequences, and costs, of the problem occurring.
- · Implement measures
to prevent reoccurrence of the problem
- · Demonstrate to
clients and regulators that you are in control of your processes
- In the example of a faulty probe; you need to replace the probe. But
you should also determine and document as part of the “Deviation”
process:-
- How long has the probe been malfunctioning?
- What, if any, batches/products are affected by the failure?
- Can those batches still be released; do you have enough data from
other probes in the system to be confident that the batches are
satisfactory?
- Why the probe failed, was it a simple failure of the probe or is
there some other underlying cause?
- What can be done to prevent such failures in the future? Consider
reviewing your preventative maintenance schedule to replace probes before
they get to the point of failure.
- So the Deviation process improves your understanding of how your
system works and if done well should not just ensure compliance with the
regulations but also help to reduce costs in the future.
-
- Regards
- David Ward
- Cymru Consulting
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