Sample Manufacturing Plan or Template for Medical Device Contract Manufacturer

Greetings. I started working for a contract manufacturer who makes and supplies parts/assemblies to (primarily) medical device companies.

One med device customer, recently asked for a manufacturing plan. I have searched through this forum but did not find any templates or samples. The customer is looking for information such as a schedule, part management, process flow, training, etc. If anybody has any samples, I would greatly appreciate the assistance. Regards,

dkcmc said:

Greetings. I started working for a contract manufacturer who makes and supplies parts/assemblies to (primarily) medical device companies.

One med device customer, recently asked for a manufacturing plan. I have searched through this forum but did not find any templates or samples. The customer is looking for information such as a schedule, part management, process flow, training, etc. If anybody has any samples, I would greatly appreciate the assistance. Regards,

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Good day dkcmc,

This sounds like the sorts of things your Quality Manual would talk about. Does your organization have a Quality Manual?

Hi Jennifer. We do have a quality manual - I am searching for a more customized template and/or outline for a contract manufacturing build plan targeted for the medical device or pharma industries. Thanks in advance.

I'm perplexed as to what such a document would be in template or generic form.

You know what you currently do, and what you'd like to improve. What good would a generic manufacturing plan be, if it didn't match what you currently do or would like to improve?

MIREGMGR said:

I'm perplexed as to what such a document would be in template or generic form.

You know what you currently do, and what you'd like to improve. What good would a generic manufacturing plan be, if it didn't match what you currently do or would like to improve?

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Perhaps the above was not clear. I just started and I am not yet familiar with the contract manufacturing business or the customer product. If I could receive a specific med device manufacturing build plan, that would be the best option. However, I believe a generic build plan will be helpful as well (in the sense of a rough outline or format). The intent is not to improve on anything, but simply reference a sample build plan before I start writing one on my own. Hopefully, that clarifies. Thanks,

One thought would be to look for general quality plans (lots on the internet) and then use that as your template or basis on which to write your own. We create a quality plan for each new product, using a flow chart format. We can then look at the process and see where we may need to add/improve procedures or processes to address any issues specific to that product.