Deviation Reports - Is Implementation Date equal to Date of Completion

[Raffy]

Is Implementation Date equal to Date of Completion? What could be the allowable number of days do I have to specify in our procedure for date of completion? Please comment.
Regarding follow-up would ten working days be enough for the auditee to have an ample time to answer their discrepancy and made some corrective actions? Please advice.
Thank you very much,
Raffy

[Marc]

Implementation date is the date you start the process. If you are implementing a corrective action, the date you start the 'fix' is the implementation date.

The completion date could be 2 things. You don't give enough info. Typically the completion date is either the date the implementation is finally completed (some implementations are done in a day - some are done in a month, etc.). Then it is verified to be effective. More typically the completion date is the date the CA is actually closed out.

You can set a date for a reply or for a status update but until you exactly what the corractive action is going to be you can't set a completion date. Some corrective actions are complex and require long tersting scenarios to complete. Some can be done in a day.

10 days should be plenty of time to ask for an initial reply to a finding or event and for an interim corrective action to be put in place. Most of the time interim corrective actions are done within a day ort two.

[This message has been edited by Marc Smith (edited 15 April 2001).]

Raffy,

Does your system differentiate between corrective actions that result from product nonconformance (4.14) and internal audit (4.17)?

If you are refering to an ISO-9000:2000 system disregard my question.

ASD...
ASD...

I agree with Marc. I think 10 days is adequate to require a corrective action plan. Just the plan, not the actual correction! That will depend on a couple of things. 1. the amount of time it will take to develop, test, and implement a fix, (you don't want to have a less than acceptable correction because you didn't allow enough time to do it right!), and 2. how long management is willing to live in a state of non-compliance, based on the risk of getting busted with your system still non-compliant. (Busted means either getting caught by another audit, or having your systems fail you because they aren't working correctly). Most auditors will consider your having a plan in place and as long as it appears to be a valid plan, (i.e. it addresses the issue and appears to be a legitimate time frame), will not cite you again. Setting time frames for corrective actions is always a tough issue as different fixes take different resources and time. I would just require a set response time for your corrective action plan and then evaluate each plan as to whether or not it's being addressed quickly enough. Changing a procedure is usually much easier and quicker than developing a new manufacturing process, and thus would take less time. One thing we do is look at short term and long term corrective actions. Short term limits the possibility of having another failure through extraordinary activities, (e.g. extra inspections, testing, etc.), and long term eliminates the possibility of failures as a matter of process, (e.g. SPC). A corrective action plan is not a complete plan without an anticipated closure date, which is what we use as a tracking mechanism to monitor progress.

Good luck and let us know what you end up doing.

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See you down life's highway!

Eric