Manufacturing Process Control

Hi, I was wondering what to do in my situation. I may also just be misunderstanding this section a bit.

The standard says that we should identify the potential quality defects that could reasonably occur, identify the process control points to prevent or limit the risk of the quality defects, and establish machine settings or control limits for each of those control points.

So my understanding is like this example: If there's too much heat we get warping, so we need to establish the acceptable limits for the temperature that the machine runs at.

Our thermoforming machines need to be adjusted fairly frequently and make custom packaging. So we have hundreds of different but similar products that each have their own settings. The settings may also depend on which material thickness or other factors.

We check if the product meets specifications and if not then we adjust the settings to fix whatever the issue is. So how can I establish machine settings or control limits for the control points? (I assume a control point would be like maintaining a certain heat for example)

This is a fundamental clause so it is really important, and maybe I am not understanding it correctly.

Thank you

It sounds like you have the starting point specs, there is just a significant range within the specification that requires some continual verification testing to manage.

Set your acceptable range wide, set your verification frequency to be flexible.

With hundreds of products, creating a spec could really be a pain.  However, I understand the requirement calling this out, as you need line operators to have some type of guidance to produce reliable products vs just trial and error each time you start the line.

Do you have data from prior runs showing which temp settings worked for the products?  If you can consolidate the info and group the items by the set temp, I'd be tempted to list all of the products that work at each temp range and then insert that as a table into the SOP.  Have the table available to the line operators as a guidance sheet, so they know if they're running product A, B, or C, set temp to X; product D, E or F, set temp to Y.

Doing it this way could help simplify record keeping during production.  The monitoring form could have a space for the product name/code, instruct the operator to refer to your table and write down the temperature setpoint, then record the temperature checks at whatever frequency you've prescribed.