API Spec Q1 (clause 5.11.2 d) specify that; the organization shall use the MOC (Management of Change) process when changes to the management system procedures are made, including changes resulting from corrective and preventive actions (see 6.4).

Does that mean a complete MOC process need to completed, when organisation is making changes to the procedures, work instructions, work standards, plans, formats etc.

Interpretation / Explanation

The intent of the API Spec Q1 (clause 5.11.1) is that; organisation has to maintain the integrity of the QMS (Quality Management System) when changes to the QMS are planned and implemented.

And as per Q1 (clause 5.11.2) MOC need to be performed when the proposed change may negatively impact the product quality.  

Based on above requirements; if any document change may produce a negative impact on the product quality then MOC shall be performed.

Otherwise; if the resulted change in not impacting the product quality and changes are strengthening or improving the QMS then there is no need to perform the MOC.    


Disclaimer: This interpretation is given only for guidance and is solely based on the author’s learning experience in API eco system. Before making any judgment, readers are advised to use their own understanding based on their organisation’s requirements.

Note: API doesn’t endorse this interpretation as a part or in totality.