Framing Standard Process Conditions (SPC) and specifications

“as it is highly impossible to frame new specifications and process parameters on daily basis” – Forget ISO 9001 for a moment: How does your organization control process and specifications today? If a client orders a new batch of the last color he ordered, how can your organization efficiently manufacture the same color?

If you can do it you have a method and that method answers to the ISO 9001 requirements.

Look into clause 8.5.1 that details several relevant topics. Some of them are:

• Products and Services to be produced defined and characterized with results to be obtained
• Availability of adequate monitoring and measurement resources
• Process and Product & Service control defined and implemented
   

You can find more information below:

• List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/
• ISO 9001:2015 clause 8.5 Product realization – Practical examples for compliance - https://advisera.com/9001academy/blog/2015/11/03/iso-90012015-clause-8-5-product-realization-practical-examples-for-compliance/
• Free online training ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-14001-internal-auditor-course/ nal-auditor-course/
• Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
   

Based on your answer, let us suppose that the only relevant parameter for the customer is the color. So, you use as quality control specification the master sample. Whenever you have a repeated order you use the master sample to evaluate and release the batch. It seems ok as long as color is the only parameter. I would keep a record of each batch sent to customers and I would train and validate competencies for color evaluation if you don’t use a monitoring resource.

About process conditions, I’m thinking on the example of injection molding companies that just record a basic set of conditions from a previous production, and use those conditions as a starting point for the new production, then with the help of quality control of samples during production they fine tune the right conditions for that day.