Customer notification of processing changes - Class I medical devices

#1
My small company manufactures almost 1500 products and I'm looking for a good plan (SOP) for managing customer notification for processing or raw material changes.

Anyone know how I should start?
 
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Wes Bucey

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#2
Kelley said:
My small company manufactures almost 1500 products and I'm looking for a good plan (SOP) for managing customer notification for processing or raw material changes.

Anyone know how I should start?
Are your products custom-made to customer's design or off-the shelf (where the same product may go to more than one customer?)

In the first instance (customer design), you ought to negotiate with each customer as part of contract review on what the customer requirement will be.

In the second instance (off-the-shelf), the form, fit, and function are the primary criterion, not your process.

If you (for example) made fasteners, changing the material (not the source of the material) might be important, but it should also trigger a part number change.

Similarly, if you made threaded fasteners, customers would probably not care whether you cut threads or rolled them if your tolerances remained the same and the physical strength characteristics of the product remained the same.

In some instances, even if your products are off-the-shelf, some customers may have esthetic or political reasons for wanting to know raw material sources. However, they don't have a right to ask or demand unless you agree as part of the contract.

If this doesn't resolve your question, give us more details to work with. (Automotive? Aerospace? Medical? Type of products? Materials?)
 
#3
The vast majority of our products are off the shelf. We manufacture Class I medical devices (microbiological culture media). However, a large number of our customers are pharmaceutical companies who insist on knowing everything about any changes to the products that they purchase.

We have a large customer base and a large number of products that we manufacture and I'm just not sure how to manage the changes that seem to be frequent.
 

Wes Bucey

Quite Involved in Discussions
#4
Kelley said:
The vast majority of our products are off the shelf. We manufacture Class I medical devices (microbiological culture media). However, a large number of our customers are pharmaceutical companies who insist on knowing everything about any changes to the products that they purchase.

We have a large customer base and a large number of products that we manufacture and I'm just not sure how to manage the changes that seem to be frequent.
Maybe this is too simple an answer to work.
How do you track and record these changes internally?
(I imagine you maintain a record according to the individual product which gives the complete history of production changes and sources of raw materials [incoming inspection and shipping tags?] by date and batch number.)

I presume the record also shows to which customer each product goes.
Therefore, if we have Product A, we might also add a tag to each supplier, based on response during contract negotiation, indicating whether the documentation for a particular shipment should also include a notice of any process or raw material source changes in the intervening period between order date and shipment date. I don't see this as any more of a problem than some customers who dictate specific label data be included on each package.

Many order tracking software packages are capable of this chore, automatically generating reports in the exact format required by the customer to be included in the shipping documentation, at the same time they print shipping labels, inspection reports, invoices, and other shipping documents.
 
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