Manufacturing Process Design and Development Review

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somashekar

Staff member
Super Moderator
#2
How we can audit "Manufacturing Process Design and Development" in ISO 9001:2008
If I get you correctly., you are talking about the audit of the Design and development review per the 7.3.4.
Here you have to look for the participation of representatives of functions concerned to design and development stages, in your case, the manufacturing stage for the manufacturing feedbacks and concerns or in other words manufacturability.
Records of inputs from the manufacturing in the review and outputs of the review as decisions concerning to the inputs provided, will have to be maintained.
Your audit can look for what review inputs have come from manufacturing specialist personnel, and how the necessary actions have been arrived at.
 

qusys

Trusted Information Resource
#4
How we can audit "Manufacturing Process Design and Development" in ISO 9001:2008
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.:bigwave:
 

somashekar

Staff member
Super Moderator
#5
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.:bigwave:
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.
Request kedarg to comment over the posts so far and let us know if he has found what he wanted.
 

kedarg6500

Quite Involved in Discussions
#8
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?
 

Big Jim

Trusted Information Resource
#9
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?
That is 7.1.

Among the items that falls under 7.1 for most companies is fuguring out how to make the product. Often the manifestation of that is the development of the traveler (or work order, job ticket, or whatever you call the production document).

One of the notes following 7.1 goes so far as to explain that you can use the concepts from 7.3 (design and development) for production planning.
 

somashekar

Staff member
Super Moderator
#10
2. After this "Manufacturing Engineering Department" develops suitable processes to produce that Product/Component
A major part of this activity comes from following:
1. The volume of product / component that needs to be manufactured
2. The available resources
3. The extent of processes that are outsourced
3. That means they design the "Manufacturing Process"
Yes. This is what is expected in the 7.1 as put under.
b) the need to establish processes and documents, and to provide resources specific to the product;
c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance;

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?
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".
Also remember that the plan of your control of outsourced processes will consider this requirement appropriately. Since manufacturing process as such is specific and a thing can be made in more than one way, it is indeed covered broadly within the 7.1 and specifically in 7.5 of ISO9001, which one needs to map as applicable to the organization and the audit process must identify these and proceed.
 
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