API Specification Q1 Addendum 2
- June 21, 2018
- Posted by: Julius Lansang
- Category: Uncategorized
API Specification Q1 Addendum 2 has just been published with a 1 year implementation deadline of June 2019 for Monogram Licensees and Q1 certified organizations. When you think of the word “addendum” you probably think of something insignificant added at the end of a document. Probably no big deal, right?
Well, this addendum is a big deal. As a member of API SC18, the API Sub-committee on Quality that is responsible for the development Specification Q1, I know what the changes are and the impact it will have on your QMS and purchasing processes. We are already creating a new version of our Q1 9th Edition online course that incorporates and explains these changes.
What is the addendum all about? “SUPPLY CHAIN”
Q1 defines “Supply Chain” as: “Suppliers and associated sub-supplier(s) required for product realization.” The addendum is not just an add-on but actually modifies every part of the specification that deals with purchasing and the selection of suppliers and sub-suppliers who provide products or perform critical processes that impact your product. Essentially, Q1 now requires you to take full responsibility for ensuring the quality of purchased products and services throughout the supply chain.
If a sub-supplier performs a critical process that impacts product performance, Q1 now requires you to verify the controls needed to provide assurance that those sub-contracted processes and resulting products comply with established acceptance criteria. So your procurement and QA processes are about to have a lot more responsibilities.
Call us if you have any questions about how this will impact you. We are here to help.