DLesterB
Registered
I've seen similar threads on the Forum, but most are outdated, and the following question not definitively answered:
Document Control for Medical Device (21 CFR 820 and ISO 13485) - can a document author/owner also be the document final approver?
Here's the gist,
As the only person in the organization with med device experience/expertise, I was tasked to implement a compliant device-specific QMS from scratch. The challenge is the prevailing thought that I am the only employee capable of writing effective device QMS procedures, while also being the only employee qualified to evaluate these procedures to ensure compliance with med device regulations/standards and the QMS I am currently constructing. There are 2 other quality assurance staff (Pharma experienced) who I've just recently trained on 21 CFR 820 (vs. 21 CFR 210/211 that they are familiar with).
Our document approval process requires identification of the document author/owner, an approver (someone with pertinent quality system process experience), and a final QA approver (ensures compliance with applicable regulations/standards and the Management System). The other two QA staff do not feel qualified to perform the author/owner or QA Approver functions, but feel they have enough GMP quality system process knowledge to serve as the 'middle' approver.
So, to rephrase the question, would an auditor accept a document control process where quality management system procedures written and owned by a medical device SME are also approved for compliance with medical device regulations/standards and the associated QMS by that same SME? Or would that process be verboten as an auditor would view that as someone approving their own work?
Discuss........
Document Control for Medical Device (21 CFR 820 and ISO 13485) - can a document author/owner also be the document final approver?
Here's the gist,
As the only person in the organization with med device experience/expertise, I was tasked to implement a compliant device-specific QMS from scratch. The challenge is the prevailing thought that I am the only employee capable of writing effective device QMS procedures, while also being the only employee qualified to evaluate these procedures to ensure compliance with med device regulations/standards and the QMS I am currently constructing. There are 2 other quality assurance staff (Pharma experienced) who I've just recently trained on 21 CFR 820 (vs. 21 CFR 210/211 that they are familiar with).
Our document approval process requires identification of the document author/owner, an approver (someone with pertinent quality system process experience), and a final QA approver (ensures compliance with applicable regulations/standards and the Management System). The other two QA staff do not feel qualified to perform the author/owner or QA Approver functions, but feel they have enough GMP quality system process knowledge to serve as the 'middle' approver.
So, to rephrase the question, would an auditor accept a document control process where quality management system procedures written and owned by a medical device SME are also approved for compliance with medical device regulations/standards and the associated QMS by that same SME? Or would that process be verboten as an auditor would view that as someone approving their own work?
Discuss........
