posted 23 May 2001 10:00 AM               

We have a follow-up or "audit" on each Corrective and Preventative Action item brought up, no matter how minute. It is actually part of the Request for Action (RFA) form we use to log and track CAR's & PAR's. Upon completion of the CAR/PAR, the RFA is logged into the system and I assign a follow-up date. This follow-up date is based upon the nature of the CAR/PAR and is designed to be timely, yet allow enough time for the action to be properly and thoroughly tested. If, during the follow-up, further corrective/preventative action is required, the matter is brought back before the Management Team or individual assiged to develop the resolution to the situation for further action.

Hope this helps.

Cheers!

posted 23 May 2001 10:19 AM               

I believe you are asking about findings from internal audits and how they are handled. For any findings from Internal Auditing we issue a CPAR. There is a (reasonable) proposed close-out date. The Corrective or Preventive Action is checked for effectiveness. If it is still ineffective, it goes back to the Quality Board for re-evaluation. My personal feeling is that if I find problems while I'm doing internal auditing, chances are it is a problem. You might as well deal with it while it is a small problem, rather than wait until it is huge and your registrar finds it!

Hope this helps!

posted 23 May 2001 05:40 PM               

I've used a system where the lead auditor (generally the Management Rep) has discriminatory authority to either issue an NCR or a "notice of issue". The CAR followed the classic approach for corrective action, the notice of issue was documented in an audit report that the auditee signed but a formal documented resolution was not required. The MR kept track of the notices and made them available to the auditors for subsequent audits. In many cases, the audit frequency was adjusted if a notice was issued.

We used a major/minor classification system to decide whether an NCR or notice would be desireable.

I typically use this type of system early in an implementation to minimize the amount of paperwork that could flood the system as the system gets up to speed. Many times, after about a year or so, it's almost easier to issue an NCR for all findings.

posted 24 May 2001 06:35 AM               

How you doin'?

Have you ever seen my CPAR form? There is a place to write a corrective or preventive action. Below that is a space to have the department manager to sign off that the corrective or preventive action has been implemented. Under that I get the QA Manager to sign off that the action was effective. Essentially, if you go back to do a 'follow-up audit' and the problem still exists, your corr/preve action was not effective. Go back to the ol' drawing board and figure out something else. Why, haven't you ever had this happen to you?