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Identification & Traceability Application Differences

M

MDWEEK

#11
#11
ok i give details for clearance It is building construction company and design process is divided into 3 parts
1- the organization makes designs from a-z.
2- consultant company prepares the design from a-z and give to our company to apply it.
3- sometimes a consultant company puts primary designs and our company complete the detailed designs and then apply it.

thanks
 
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Colin

Colin

Quite Involved in Discussions
#12
#12
OK, so you must explain about these 3 methods of producing designs - I would do so in the quality manual myself. Either way, you are still responsible for the designs, whether you do it yourself from start to finish or if you outsource it (see last para in 4.1) .

In addition, you must address all other processes such as taking on new work (7.2), purchasing (7.4), etc. You also of course have to satisfy all other aspects of the standard such as internal audits, management review, etc.
 
V

vanputten

#14
#14
Identification is not just part number like information. It includes the product or test status of what is under consideration. Part number like info may or may not meet this requirement.
 
Y

ywang

#15
#15
MDWEEK said:
1-What is the difference in application between identification& tracibility?:thanx:
2- in d&d shall i mention only what the company is doing in design process ?
Click to expand...

1. Interpretation may differ. You'll have to provide more details or decide for your own case.

For me, Identification means going on the floor and being able to show the auditor what a product/document/record is, what its purpose is and how we use it.

Traceability, for me, means being able to track a batch/lot from any point in our process. Often I've had to track a lot requested by the customer. If I can find records at each step of our processes and trace exactly what happened to this product, then I have traceability.

2. Your wording is somewhat unclear here, but haveing gone through our rough and tumble R&D process recently, I think I know what you mean.

Design and Development starts with a customer need/requirement, goes through the 3 steps you mentioned in your other post, and continues through manufacturing/construction all the way to customer feedback. It is, for us, much more than coming up with the blueprint.

I'm not clear on who your customer is. It is one thing I see missing in the information you provided so far.

With that said, you should include whatever you feel is necessary in your QMS. The standard is fairly adamant on customer input and satisfaction.

Let me know if this helps.
 
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