3 replies to this topic

[WorkingFromWork]

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

 

[G M]

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.

[jfrey123]

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.

[Tony-C]

Hi WorkingFromWork,

 

As previous Clause 5.4.4 has been removed in Issue 7, I think that you have most of this covered off

 

Previous Clause 5.4.4 from Issue 6:

Where equipment settings are critical to the safety or legality of the product, changes to the equipment settings shall only be completed by trained and authorised staff. Where applicable, controls shall be password-protected or otherwise restricted.

 

Presumably you have covered:

Clause 5.4.1 - Recording all potential product quality defects

Clause 5.4.2 - The site shall identify manufacturing process control points that can prevent or limit the risk of producing products with quality defects.

Clause 5.4.3 - Machine settings are established and documented

Clause 5.4.5 - Manufacturing process checks to ensure products meet agreed specification

 

Also note Clause 5.4.6 - In the event of equipment failure, or deviation of the manufacturing process from specification, procedures shall be in place to establish the quality status of the product and determine the action to be taken in accordance with clause 3.11.

Clause 3.11 is Control of non-conforming materials

 

The Fundamental requirement statement of intent is:

Procedures, work instructions and specifications shall be in place to ensure effective compliance with product and customer requirements throughout the manufacturing operations.

I don’t see a major problem with your system as you have typical settings and you are checking against specification. It is not like these settings are a safety issue, they are what is typically required to produce a product of acceptable quality. If your procedure states you start up with the typical settings and confirm the product meets specification at start up and adjust the settings if required, then confirm product meets specification then that would seem to be acceptable and practical.

 

Kind regards,

 

Tony