kedarg6500
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How we can audit "Manufacturing Process Design and Development" in ISO 9001:2008
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If I get you correctly., you are talking about the audit of the Design and development review per the 7.3.4.How we can audit "Manufacturing Process Design and Development" in ISO 9001:2008
How we can audit "Manufacturing Process Design and Development" in ISO 9001:2008
It is clear from the sub forum heading and the single line opening post that the OP refers to the ISO9001:2008. andreww has posted the group paper from the IRCA which has good insight into the D&D audit process.You can refer to ISO guideline in this sense.
I have not the link at my hand now, you can make a research there.
However I think you are referring to ISO TS clause 7.3 that also applies to mfg process, ISO 9001 refer only to the product and not to the process.
7.3 clause of ISO TS can be excluded for the product but not for the process, while in ISO 9001 the difference is not a clause , but it is recommendation for continuous improvement.
How we can audit "Manufacturing Process Design and Development" in ISO 9001:2008
I will try to explain what I want
1. We get Product/Component drawings from Product Engineering Department
2. After this "Manufacturing Engineering Department" develops suitable processes to produce that Product/Component
3. That means they design the "Manufacturing Process"
4. I feel it is similar to ISO 9001 clause 7.3 "(product) design and development"
5. I want to know how to Audit "Manufacturing Process Design" under which ISO 9001 clause not TS clause?
6. Why ISO 9001 has not covered "Manufacturing Process Design and Development Review" with seperate clause?
A major part of this activity comes from following:2. After this "Manufacturing Engineering Department" develops suitable processes to produce that Product/Component
Yes. This is what is expected in the 7.1 as put under.3. That means they design the "Manufacturing Process"
When you audit the 7.5 process and its ability to have met the requirement of customer, you are covering this aspect of what you mention as "Manufacturing Process Design".5. I want to know how to Audit "Manufacturing Process Design" under which ISO 9001 clause not TS clause?
6. Why ISO 9001 has not covered "Manufacturing Process Design and Development Review" with seperate clause?