Changes that affect the QMS in Management Review - Clause 5.6.2

[Sean Kelley]

Hello all,
I have been given a Scope for Improvement by our auditor to do more on the Management Review section 5.6.2 Review Input item f). It states that we must report on changes that could affect the QMS. I have always used the changes to procedures as a basis for this. He is telling me I should expand this and include other changes. An example that he quoted was that a QC engineer was promoted to a process engineer position. As a QC Engineer he did calibrations in the lab. He thinks this is a change worth noting in management review. I view it as a resource need to be filled by the next QC Engineer which they are looking for. I believe the calibrations could also be outsourced if deemed necessary even if only temporary. Also, the old QC engineer is still here so he could be asked to perform this task when it arises if need be. Any thoughts / suggestions on possible other changes that affect the QMS would be appeciated.

[Casana]

I think some examples of changes that would be worthy of noting during a Management Review:

a) reorganizations (e.g. department mergers)
b) relocation (of offices, manufacturing, warehouse, etc)
c) new business (e.g. if you're planning to enter a new market)
d) changes to current business (e.g. perhaps you're dropping a product line, outsourcing some work that used to be done in-house, etc.)
e) Major changes to the facility (e.g. new production line, building a new lab)
f) Major changes to your raw material supply that could have a ripple effect on your product (we are changing one supplier, is having a huge ripple effect accross our company)
g) Identifying need for new system (i.e. even though we weathered Katrina's impact ok, it motivated our mgt to do a comprehensive business continuity plan)

The point is that these types of changes also impact the quality system, even if they are not specifically related to "quality".

[AndyN]

Originally Posted by Casana

I think some examples of changes that would be worthy of noting during a Management Review:

a) reorganizations (e.g. department mergers)
b) relocation (of offices, manufacturing, warehouse, etc)
c) new business (e.g. if you're planning to enter a new market)
d) changes to current business (e.g. perhaps you're dropping a product line, outsourcing some work that used to be done in-house, etc.)
e) Major changes to the facility (e.g. new production line, building a new lab)
f) Major changes to your raw material supply that could have a ripple effect on your product (we are changing one supplier, is having a huge ripple effect accross our company)
g) Identifying need for new system (i.e. even though we weathered Katrina's impact ok, it motivated our mgt to do a comprehensive business continuity plan)

The point is that these types of changes also impact the quality system, even if they are not specifically related to "quality".

Nice job, Casana - these are great examples of what really could be considered.



Andy