Design Transfer to production = New product introduction ??

[Velyn]

Hi Folks,

I needed some help here. My company is manufacturing Class ii medical devices and I was being task to write SOP or perhaps work instruction for design transfer to production (supply chain manufacturing).

Yet, I am getting confused when I was told to write about the procedure of design transfer to production which include New Product Introduction as well as initial production lot in manufacturing upon receiving all spec required from R&D (BOM, drawings, spec). In the same SOP/WI, CFR 820.70 (production and process controls) requirement must also be included. And finally, procedure about DMR is released to production.

I'm from engineering department and I don't really have in depth knowledge to write Quality related document especially regulatory topic like design transfer, DMR etc

Have anyone ever wrote such a SOP about design transfer, new product introduction and PnPC in one document...? Or should the topic be written in separate SOPs instead of one?

Any examples can share?

Thanks for the help.

 

[Julie O]

My best recommendation to you is that, if you are not already actively seeking employment elsewhere, do so. However, since new jobs are rarely had at the snap of the fingers, here is some guidance to tide you over until you move on:

1) SOPs should describe how things are being done, not how they should be done.

2) The best people to "write" an SOP are the people who are doing the process to be documented in the SOP. These people don't necessarily have strong writing skills, so they may need some assistance with the actual writing, but they should be the source of the content. They should also be the drivers of the SOP development process.

3) "SOP" is singular. The process being documented should be singular too. One process = one SOP.

4) Start by defining the point at which the process (eg, design transfer) starts. Identify what has to have been done in order for you to be ready to start the process, and also anything you need (eg, documentation) to start the process.

5) Next, define the point at which the process is "completed." Identify the people that need to be notified of its completion, the documents that have been generated in the course of completing the process, and what needs to be done with those documents.

6) Then it's just a matter of filling in the steps in between.

7) Don't list the content or organization of files or other documents in your SOP. Develop documents titled "Organization and Content of..." or "Format and content of..." and reference them (or attachment them to) your SOP.

Good luck. I'm afraid you are going to need it.

 

[Velyn]

Julie for the guide. I would discuss with my dept about it that different processes/topics should be of separate doc and reference to each other where appropriate instead of jumble all together in one SOP.

Agreed with your point that one SOP should address one process in details on how it's being carried out (i.e design transfer, NPI, PnPC in separate doc)..

My thoughts is that FDA CFR820 requirement should probably be addressed in written QMS doc/policy and each process owner (i.e, engineering, manufacturing, purchasing etc) would prepare our own process SOP that compliance to regulatory requirement.

By the way, would you mind share with me on what made you think of recommending to seek new employment? Was it my role and responsibility doesn't comply with the task given? Speaking of that, would auditor ever question/fault a company about responsibility and ownership of quality assurance document which is written by other not from quality dept who may not have good knowledge for certain standard ie ISO13485, CFR820?

Again, thanks for your guide. I really appreciate it that I'm still learning to understand more about regulatory for medical devices manufacturing industry.

 

[Julie O]

would you mind share with me on what made you think of recommending to seek new employment? Was it my role and responsibility doesn't comply with the task given?

Oh, it's mostly because I'm old and have seen too much of everything too many times before,. Yes, generally it does not sound to me like your company has the internal knowledge and resources it needs to support a good quality system. This doesn't necessarily distinguish it from many other companies out there, but I have learned that life is short and it's better not to spend too much of it beating your head against a wall that is unlikely to move.

I will be interested to hear their reaction to your recommendations. If they are accepted with enthusiasm and then promptly implemented, I will withdraw my suggestion.

would auditor ever question/fault a company about responsibility and ownership of quality assurance document which is written by other not from quality dept who may not have good knowledge

I think an auditor is unlikely to question the authorship if the document itself does what it needs to do. I think this is harder to achieve if the author does not have good knowledge of the subject matter.

 

[Velyn]

I see understand your rational.

For my company perception is that author is the subject matter e.g. manufacturing processes, therefore my dept should own QM SOP eventhough the author may not fully understand iso/regulatory requirement. We do understand well about processes but not regulatory requirement i.e process validation requirement.

Yeah, it's hard to achieve for those who don't have the background.