Design Control Procedures later in the Development Process

[Thales]

Hi all,
I recently joined a medical device start-up for putting in place a QMS. We are in Design and Development Phase and using a contract manufacturer. Until now we were relying on the CM's quality system and documentation, however I now want to put in place Design Controls procedures from our side as well. My question is how exactly should I properly document it and implement it, since the effective date of our procedures will be much later after the design and development process actually started? What would be the best way to integrate documents from our CM (different numbering and everything) into our Document System?

 

[Tidge]

My question is how exactly should I properly document it and implement it, since the effective date of our procedures will be much later after the design and development process actually started?

I recommend performing a gap analysis of the development activities (and documentation) performed prior to implementation of the initial procedures. Ideally such an analysis would occur prior to transfer to production, so as to avoid potentially serious issues. The gap analysis belongs in the DHF for the devices.

 

[indubioush]

The way I have done this before is to explain the situation in a design project plan document. Have you done design verification yet?

By the way, it may be unnecessary to have all of the CM documents in your system. You should have specifications for your device, and the CM can have their own documents to show how they meet those specifications. In your medical device file, however, you will need to have copies of thier documentation. Moving forward, you will need to be notified prior to implementation of any change at the CM that affects your product. You will need to have a quality agreements that states as much.

 

[atitheya]

Hi all,
I recently joined a medical device start-up for putting in place a QMS. We are in Design and Development Phase and using a contract manufacturer. Until now we were relying on the CM's quality system and documentation, however I now want to put in place Design Controls procedures from our side as well. My question is how exactly should I properly document it and implement it, since the effective date of our procedures will be much later after the design and development process actually started? What would be the best way to integrate documents from our CM (different numbering and everything) into our Document System?

I think you should define the review, verification and validation activities you would like to perform or witness and at what stages (right from planning to final output), depending on the amount of control you want / need to exercise. You would also need to ensure that the risk management activities are sufficiently carried out and the results are considered in the design process.

Would like to know other views on this.

 

[Thales]

The way I have done this before is to explain the situation in a design project plan document. Have you done design verification yet?

By the way, it may be unnecessary to have all of the CM documents in your system. You should have specifications for your device, and the CM can have their own documents to show how they meet those specifications. In your medical device file, however, you will need to have copies of thier documentation. Moving forward, you will need to be notified prior to implementation of any change at the CM that affects your product. You will need to have a quality agreements that states as much.

We are currently in design verification phase. There is of course a commercial agreement with the CM and I am currently drafting one specifically for quality documentation. If I understand you correctly, in the DHF I will need copies of the CM's documentation, but nothing else outside of DHF?

 

[Thales]

I recommend performing a gap analysis of the development activities (and documentation) performed prior to implementation of the initial procedures. Ideally such an analysis would occur prior to transfer to production, so as to avoid potentially serious issues. The gap analysis belongs in the DHF for the devices.

I will do a gap analysis, thank you for the idea!

 

[indubioush]

We are currently in design verification phase. There is of course a commercial agreement with the CM and I am currently drafting one specifically for quality documentation. If I understand you correctly, in the DHF I will need copies of the CM's documentation, but nothing else outside of DHF?

That is a pretty open ended question. It will be up to you on how you manage the connection between your requirements for product and the way the CM meets those requirements. There is no need to have all the CM's documents approved through your system. You will need to demonstrate that you have control over the quality of your product even though another company is making it for you. Hope that makes sense.