Nadcap finding Inadequate Procedure and Inadequate Root Cause Analysis

[J Allen]

Several NCRs were written for procedural issues during a recent Nadcap audit. In my attempt to determine root cause by asking why the discrepany occured, I concluded that the procedure was inadequate and did not meet items called out on the Nadcap checklist. The procedure was incomplete in that it did not address the requirement.
I was told that I did not go deep enough into root cause determination. Why was the procedure inadequate? What would be a possible solution? How do you determine the adequacy of a procedure that has been in effect for a long time and was belived to be OK, but now it is not. or how do you determine that a new procedure is OK. Sorry for rambling but I need to provide corrective action.

 

[ssz102]

the contents and feasibility are not enough for your documents from your said
whether the structure of document are discuss or not prior to develop it including actually use and running
did the documents are review after accomplished prepare
finally, one document should be contain the scope and purpose and difinition and process and related support documents and form etc

 

[andygr]

"did not meet items called out on the Nadcap checklist"
Without seeing the exact write up it appears as if you were written up for not ensuring that your procedures incorporate the specific wording in Nadcap checklist requirements. ( A discussion on if this can be a valid finding based on their internal procedure NOP 002 is a whole separate discussion).
The key is why you thought you covered the element of the checklist question after the checklist wording "documented procedure shall include".

You can always blame it on based on performance and application results your current wording was determined to be acceptable for the system you have and you’re not appreciating that your procedure had to directly state the wording in the checklist in order to be in compliance.

 

[J Allen]

I think if we had used the checklist as a tool for review of the procedure instead of the process we would have been better off.
I think our guy just circled yes or no on the audit question without actually verifying how we met the requirement procedurally. What did our procedure say and what objective evidence supports what we say we do.
Nadcap is really making us look at our procedure process which is a good thing. We apparently felt warm and cozy with a procedure that had been in place for some time that previous Nadcap audits did not identify weaknesses, including our own audits.
I guess the real root cause was not the inadequacy of the procedure, but our lack of understanding and incorporation of the requirements without effective validation.

 

[andygr]

That is exactly how you have to approach it. Make sure you mirror the check list when ever it says that you shall have a procedure or document. Many firms get caught when they go by "we meet the intent" or "we have never had an issue".
The best way to prepare for the audit is that for each and every question identify the procedure/ page and para that coveres the checklist element being reviewed. What I used to do in the various procedures, which were written in Microsoft Word, was to foot note any procedureal element that was covering a Nadcap checklist requirement by including the checklist and question # in the foot note to help make sure that it was not changed in some future revision with out reviewing the checklist requirement.
Once you have verified that your are proceduraly clean then concentrate on the implementation side of preparing for your audit to make sure that you are actualy performing to what is in your procedures.