Role of QA during Design and Development of Products and Processes

[Renee]

We are small company launching our first medical device product. There is some debate as to the role of the Quality Assurance department during the Design and Development phase. There are two camps:
Camp A: QA assures compliance to QMS, ISO and the CFR in addition to ensuring that testing protocols are strong and reports provide strong evidence while being involved in the decision making that may affect the quality of the product.
Camp B: QA assures compliance to QMS, ISO and the CFR by make sure that the correct documents are completed and signed by the appropriate approvers - more of document and data control role.

In a strong D&D process, should Quality have a more active role (examples: assuring the appropriate testing is done, evaluating the validity of the test results, as well as be involved in decisions about testing sample size and statistical techniques used during analysis)?

 

[Sidney Vianna]

Welcome to The Cove!

Please have a look at this post. The role of the "quality function" will always vary from organization to organization, but in my view, the D&D process owner HAS TO BE RESPONSIBLE for all of the regulatory and customer expectations as it relates to the product design. Quality might assist, guide, steer, advise, etc....but quality should not be the policing force of the business processes and departments. Quality must be seamlessly and invisibly embedded in the business processes in order to be viable and sustainable.

Good luck.

 

[somashekar]

In a strong D&D process, should Quality have a more active role (examples: assuring the appropriate testing is done, evaluating the validity of the test results, as well as be involved in decisions about testing sample size and statistical techniques used during analysis)?

Keep quality assurance department aside. Improve the quality and systems thinking of the D&D.
Quality cannot be built in from outside. There must be quality within every process.

 

[yodon]

@Sidney Vianna is spot on. My role at my company is "Quality" and trying to be a "quality cop" is a really poor approach. I'm always looking at data like in our issue tracking systems and post-delivery to see where we might be missing the mark and where we can improve. When I do identify areas for potential improvement, it is always the process owner that's driving the change (with my nudging, of course).

One area where quality can readily contribute is to stay on top of the ever-changing regulatory and standards landscape and ensure the developers are aware and in line.

I'm also responsible for the test side and we're continually evolving our methods for breaking things. But we don't wait until the end to get involved; we're involved from requirements (are they testable?) into integration, and through V&V.

 

[Tidge]

We are small company launching our first medical device product. There is some debate as to the role of the Quality Assurance department during the Design and Development phase. There are two camps:
Camp A: QA assures compliance to QMS, ISO and the CFR in addition to ensuring that testing protocols are strong and reports provide strong evidence while being involved in the decision making that may affect the quality of the product.
Camp B: QA assures compliance to QMS, ISO and the CFR by make sure that the correct documents are completed and signed by the appropriate approvers - more of document and data control role.

Camp B is not IMO a "Quality Role", that reads more like an "Archivist Role".

During Design and Development, in addition to "general compliance", the Quality role is responsible for "specific compliance", including traceability between deliverables and adherence to plans. Simply checking for a signature on a trace matrix or a report is not fulfilling the role of a quality engineer. Similarly, it is the role of a quality engineer to (minimally) guarantee that the criteria for a deliverable are implemented (defined, documented, done) prior to approval; experienced/trained quality engineers can help to establish appropriate review criteria for deliverables.