In the event of changes that affect the QMS or organizational structure, does API Q1 require a corrective/preventive action to be initiated to document the MOC action?
Firstly, going through the different queries on this site has been very helpful and greatly appreciated, that being said, I have still been in the grey about the whole MOC process. I know that a change in the QMS or organization structure will initiate an MOC but how do I document it? Will a risk assessment suffice? Do I have to initiate a CAPA?
Also on another note, can you please advise me on how do I validate my work instructions because as I understand, it must be done on a yearly basis.
Please click this link to access a past blog post regarding API Q1 requirements for MOC. http://astontechconsult.com/api-q1-9th-edition-management-of-change/
In addition to this blog post, it’s important to note that the results of your CAPA, risk assessment and contingency planning activities should be the drivers for your organization’s MOC process. The MOC process should be used to ensure the potential risk vs. benefit of introducing change into the QMS is acceptable as well as assigning responsibilities to implement the change and to establish timing for the completion of the change. Other aspects of MOC must include communicating the change and its impact to process owners and external parties that may be affected. Although no procedure is required, records should be maintained to provide evidence that each of the aforementioned points have been addressed.
I hope this helps.