Interpretation of ISO 13485 Clause 8.4 - Analysis of Data

P

Pazuzu - 2009

#11
Re: Interpretation of ISO 9001 Clause 8.4 - Analysis of Data

Thank you for clarifying that it is NOT the ISO9001 standard. I withdraw my original post.
 
Elsmar Forum Sponsor
#13
The key point is that all of the requirements of 8.4 must be found in a documented procedure. If all of these requirements can be found in a documented management review procedure (for example), then the requirements of 8.4 will have been met (even though management review does not require a documented procedure).
 

Jim Wynne

Staff member
Admin
#14
Re: Analysis of Data

The problem is that when trying to justify certain approaches to our customers, (who have the full range of experience/knowledge and situations between them), and when trying to achieve consistency between our auditors, that kind of thing often simply isn't robust enough.
I can understand the desire for auditor consistency, but I don't think that trying to homogenize your various customers' methods is a good way to do it so long as the requirements are met.
 
R

Roland Cooke

#15
Re: Analysis of Data

I can understand the desire for auditor consistency, but I don't think that trying to homogenize your various customers' methods is a good way to do it so long as the requirements are met.

I couldn't agree more, indeed I was trying to get across that we strive to do the opposite of ramming our interpretations down our clients' throats.

Conversely we have a large number of clients wanting us to tell them exactly how to do stuff, they aren't cheered by the "if it complies, it's fine" response.

Getting the balance right is a continuous battle. If it was easy, there wouldn't be as much traffic on the Cove....
 

Jim Wynne

Staff member
Admin
#16
Re: Analysis of Data

I couldn't agree more, indeed I was trying to get across that we strive to do the opposite of ramming our interpretations down our clients' throats.

Conversely we have a large number of clients wanting us to tell them exactly how to do stuff, they aren't cheered by the "if it complies, it's fine" response.

Getting the balance right is a continuous battle. If it was easy, there wouldn't be as much traffic on the Cove....
Yes--if it was easy, anyone could do it. :D
 
F

freelovefest

#17
One thing to consider when deciding if listing the requirments for something in the QM is acceptable is that 13485 requires you to define the structure of your documentation. This generally will require you to define what constitutes a procedure, and how it relates to the quality manual.

If you have a documentation structure showing procedures as being a tier 2 document, then that is where I would expect to see a "procedure" which is required by the standard; not in the QM or even in a work instruction. It all really depends on how the client decides to structure their documentation.
 
C

CK lau

#18
Hi! Covers,

The Standard did not mention what data, so I think it is depends on the user ( Manufacturer) to determine what data will be used for the purpose of analysis, so long as it is improving or reduce the defective rate for any processes.

Correct me if I have away! :mg:
 
F

freelovefest

#19
Hi! Covers,

The Standard did not mention what data, so I think it is depends on the user ( Manufacturer) to determine what data will be used for the purpose of analysis, so long as it is improving or reduce the defective rate for any processes.

Correct me if I have away! :mg:
This is true to an extent. The standard does not say specifically what data should be analyzed, but it does tell about data types that need to be analyzed, including data related to suppliers. Most people will track defect rates, or scrap or something like that, and completely forget the other required areas of data analysis. Feedback is also an area that is overlooked in smapper organizations. People assume if they are reporting adverse events they are OK, but they also need to trend and analyze these.

Remember, the goal with 13485 is not continuous improvement, but safety and effectiveness, or efficacy. So while you want to make improvements where you see them, that is not always going to be the goal of data analysis. It is more important to show you are correcting issues you see in the data than showing how you use it to improve a process. Hope this helps a little.
 
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