ISO 17025 4.12: "...potential sources of nonconformities...shall be identified."

[lucasso]

How to fulfill ISO17025 requirement 4.12:"<...>potential sources of nonconformities<...>shall be identified."
What does it mean?

Our Acreditation Body wrote up a nonconformity for us, which sounds something like this:
"Potential sources of nonconformities are not identified in the QualityManual/Procedures."

Does the standard really requires that while setting up a qms in an organization, all potential sources of possible nonconformities must be identified?

I understand that the standard requires preventive actions when the organization is already in the process: management meeting, analysis of data, customer feedback etc all can result in finding a potential nonconformity and the source of it.

But how to identify potential sources of NC before the whole process starts? Should we just guess a few sources at random, put it in the quality manual?

 

[Stijloor]

How to fulfill ISO17025 requirement 4.12:"<...>potential sources of nonconformities<...>shall be identified."
What does it mean?

Our Acreditation Body wrote up a nonconformity for us, which sounds something like this:
"No potential sources of nonconformities identified in the QualityManual/Procedures."

Does the standard really requires that while setting up a qms in an organization, all potential sources of possible nonconformities must be identified?

I understand that the standard requires preventive actions when the organization is already in the process: management meeting, analysis of data, customer feedback etc all can result in finding a potential nonconformity and the source of it.

But how to identify potential sources of NC before the whole process starts? Should we just "guess" a few sources at random, put it in the quality manual?

FMEA's for the various laboratory processes could be a good start.

Stijloor.

 

[machrk]

How to fulfill ISO17025 requirement 4.12:"<...>potential sources of nonconformities<...>shall be identified."
What does it mean?

Our Acreditation Body wrote up a nonconformity for us, which sounds something like this:
"Potential sources of nonconformities are not identified in the QualityManual/Procedures."

Does the standard really requires that while setting up a qms in an organization, all potential sources of possible nonconformities must be identified?

I understand that the standard requires preventive actions when the organization is already in the process: management meeting, analysis of data, customer feedback etc all can result in finding a potential nonconformity and the source of it.

But how to identify potential sources of NC before the whole process starts? Should we just guess a few sources at random, put it in the quality manual?

Does this also reflect an interpretation of ISO 9001-2008 that potential risks be indentified ?
machrk aka @KerrieAnne on Twitter

 

[Stijloor]

Does this also reflect an interpretation of ISO 9001-2008 that potential risks be indentified ?
machrk aka @KerrieAnne on Twitter

As related to preventive action? Your choice. But FMEA, when applied correctly, can be very effective.

Stijloor.

 

[lucasso]

Does this also reflect an interpretation of ISO 9001-2008 that potential risks be indentified ?
machrk aka @KerrieAnne on Twitter

Can you quote the ISO9001?

 

[Stijloor]

Can you quote the ISO9001?

How about this...

8.5.3 Preventive action
The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.

Stijloor.

 

[AndyN]

It's really not that difficult! As Stijloor suggests an FMEA is a great way to go....

But just think about it - would your lab be affected if the temperature ran outside certain limits? If it would affect results, then the failure of the controls would be a 'potential source of non-conformance', wouldn't it.....???

This stuff isn't supposed to be rocket science, it just takes a bit of brain power....

 

[lucasso]

It's really not that difficult! As Stijloor suggests an FMEA is a great way to go....

But just think about it - would your lab be affected if the temperature ran outside certain limits? If it would affect results, then the failure of the controls would be a 'potential source of non-conformance', wouldn't it.....???

This stuff isn't supposed to be rocket science, it just takes a bit of brain power....

Right, but isnt the list endless? How many of those potential sources of imaginary nonconformities should we put into Quality Manual to fulfil the requirement (and satisfy AB)?

 

[AndyN]

Right, but isnt the list endless? How many of those potential sources of imaginary nonconformities should we put into Quality Manual to fulfil the requirement (and satisfy AB)?

Well, yeah.....so that's why you use an FMEA format and deal with the high RPN's first.....

 

[lucasso]

How about this...


"8.5.3 Preventive action
The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. "

Not the same as in 17025.

In 9001 they ask to write up an action which will be used to deal when potential nonconformities are spotted.

While in 17025 they ask to write up a list of sources of NC up front.