Applying clause 8.5.1

Answer

Let us check every item on that clause:
a) Do you have product specifications that describe features and performance targets?
b) Do you have the necessary monitoring and measuring resources to confirm product quality according to specifications and performance targets?
c) Do you have a process control plan that defines for each manufacturing step what is relevant to control with what frequency and within which limits in the process? (For example, temperature or pressure control). Do you have a process control plan that defines for each manufacturing step what kind of quality control should be done for raw-materials and work-in-progress materials with what frequency and within which limits? (For example, impurity content)
d) Do you have suitable equipment? (Any abnormal rate of breakdowns or lost production time?) Do you have a suitable environment? (If relevant to protect product quality – moisture control, pest control, contamination control, …)
e) Do y ou have enough people in your production process? Are they competent according to your own criteria? Are there any external competency requirements that need to be fulfilled? (For example, in a construction company, a civil engineer may be required)
f) Do you have any relevant production steps where quality cannot be measured after the step? (It is not practical, or it is very expensive) For example, do you need to ensure sterilization of tank? (You need to develop a method to ensure sterilization, then apply method and validate method by making tests. After validation ensure that you apply the method).
g) Determine risks of human error, evaluate potential consequences and implement actions to prevent it. (What Japanese call “poka-yoka”. For example, once I was distracted and started to fill the gas tank of my car. However, he could not do it, the hose did not get in the car, it was too large. It was then that I realized that I had picked the hose from the diesel and my car was on gasoline.)
h) What kind of control is needed during delivery? (No need of release or post-delivery activities

The following material will provide you more information about production control:
- ISO 9001 – Understanding Product & Service Provision in ISO 9001 - https://advisera.com/9001academy/blog/2014/10/07/understanding-product-service-provision-iso-9001/
- free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/
- book – Discover ISO 9001:2015 Through Practical Examples – https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/