I am looking after a documentation for a realeased software product, which is due for a customer audit. The employees did not comply completely with company quality policy/SDLC but they still did not do anything that will affect the quality of product. The roles overlapped but still the work was done perfectly. Can the Master Project Plan and Validation Master PLan be amended to reflect this new responsibility matrix?
The employees did not comply completely with company quality policy/SDLC …The roles overlapped but still the work was done perfectly. [/quote]
What does this mean? Did the person who programmed the software also test it? I have heard this before, but in most lean organizations, it is impossible to have someone else do the testing. The best rationale for this is to demonstrate that the protocol was reviewed and approved prior to execution and the execution was reviewed. I agree it is not the best practice but I see the revision of the the plans as a huge “LOOK HERE” when it is not really warranted. as you said the quality was not at risk.
A bigger question is Why? Why did they feel it was appropriate to not follow their quality plan and at what other times did they not follow the quality plan that you didn’t catch?
There were two major instances:The responsibility matrix given in the Master PRoject Plan about who will write,review and author was not followed. A more meaningful approach like the Validation engineer writing the IQP,OQP,PQP was followed. The original repsonsibility matrix stated that the tech lead will author these documents. So, the original RM was wrong and the one followed is more correct. The risk assessment document has some mistakes in it. The risks were not mitigated due to wrong under evaluation. But they were taken care of along the way.