8.2.4 Problems with Monitoring and Measurement of Product

M

Mario Alberto83

#1
Good afternoon everybody

I am kind of stuck with 8.2.4 Monitoring and Measurement.

I wonder if you could give me some advice on how to address this clause in QMS

I thought of having a general procedure that set the guidelines to comply with 8.2.4 and then, create separate inspection instructions.

I think a lone procedure for all inspections (in process, final, FAI, etc.) would not be the best way due to manufactured products are different with different features and would need different measurement methods and acceptance criteria and thus different inspection documents would be needed. I believe you cannot enclose all inspection details in one general procedure, they should be broken into inspection instructions aligned with the general procedure.

This would be the map I propose:

Input: Project Management receives the demand and manages the project
1) Manufacturing engineers would identify the processes needed for product manufacture
2) Manufacturing engineers develop documented processes as per “documents control procedure” guidelines.
3) Documents control procedure would direct engineers to “Monitoring and measurement procedure” so they know what to consider while creating “inspection instructions” for product acceptance.

Output: Product/family specific inspection instructions in accordance with 8.2.4 guidelines


Could you please let me know your comments

Best Regard
 
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D

Del Foster

#2
Good afternoon everybody

I am kind of stuck with 8.2.4 Monitoring and Measurement.

I wonder if you could give me some advice on how to address this clause in QMS

I thought of having a general procedure that set the guidelines to comply with 8.2.4 and then, create separate inspection instructions.

I think a lone procedure for all inspections (in process, final, FAI, etc.) would not be the best way due to manufactured products are different with different features and would need different measurement methods and acceptance criteria and thus different inspection documents would be needed. I believe you cannot enclose all inspection details in one general procedure, they should be broken into inspection instructions aligned with the general procedure.

This would be the map I propose:

Input: Project Management receives the demand and manages the project
1) Manufacturing engineers would identify the processes needed for product manufacture
2) Manufacturing engineers develop documented processes as per “documents control procedure” guidelines.
3) Documents control procedure would direct engineers to “Monitoring and measurement procedure” so they know what to consider while creating “inspection instructions” for product acceptance.

Output: Product/family specific inspection instructions in accordance with 8.2.4 guidelines


Could you please let me know your comments

Best Regard
If your work control system defined in section 7.5.1 adequately defines your product metrics then clause 8.2.4 is redundant and can relate to the previous section, but if you exempted those portions of 7.5.1 then 8.2.4 is an appropriate place to define your product M & M methods.
 
Last edited by a moderator:

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
Good day Mario,

I think you are on the right track. An inspection procedure should address the inspection process but actual measurements, tools to use, attributes, tolerances etc. are best identified with SOPs, job travelers or something similar.
 
M

Mario Alberto83

#4
Good day guys, thanks a lot for your feedback

Good day Mario,

I think you are on the right track. An inspection procedure should address the inspection process but actual measurements, tools to use, attributes, tolerances etc. are best identified with SOPs, job travelers or something similar.
Thank you Jennifer, I have a clearer idea on how to meet this clause in the QMS.

If your work control system defined in section 7.5.1 adequately defines your product metrics then clause 8.2.4 is redundant and can relate to the previous section, but if you exempted those portions of 7.5.1 then 8.2.4 is an appropriate place to define your product M & M methods. google isoyourway
Foster

I agree with you, however you need to address somewhere the guidelines to follow in order to have an adequate control and thus meet 8.2.4, I mean, you need to consider aspects in 8.2.4 by the time you develop inspection instructions.

I would not say 8.2.4 is redundant but 7.5.1 tells you where to apply 8.2.4.

Best Regards
 
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