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Trying to explain some of the Management Review Inputs (AS9100D)

ImLost

Starting to get Involved
#1
We've been working on our transition to AS9100 Rev D.
The auditor noted that he does not think our current MR is up to snuff.

Trying to explain some of the inputs to management - and I am meeting some opposition.
Does anyone have a simple explanation of each input? Im finding we have always treated 9.3.2 number 5 as tools, but Im not sure that is the intent.
 

Laura Halleck

Starting to get Involved
#3
Hi ImLost,

Could you provide some more detail so we can try to provide you with some help on your issue? What are the specific inputs you are having trouble with and how are you currently interpreting them (i.e. what data or information are you using as evidence of that input)? What was your auditor's specific feedback on this issue?

Thanks,
Laura
 

ImLost

Starting to get Involved
#5
Currently, we have been interpreting them as follows:
a. action item review
b. internal could be something like a major equipment failure, external could be getting a specialized contract we need additional training for (I think the interpretation of this one could use more explaining)
c. does anything need to specifically noted here - or move along to 1-8?
1. Survey results, customer complaints, corrective actions and feedback from those we defined as interested parties - in our case, customers, suppliers and employees.
2. reporting of our objectives and are they met, if not what are we doing about it
3. WIP, test and final reporting, high/low defect code, failure rate, etc.
4. we generally put a summary of customer rejections here; if we see a trend of specific rejections, the time it takes to close the rejection - how many opened vs. closed
5. Tool and calibration
6. Customer, supplier, registrar audits
7. supplier review
8. not sure here - our OTD is an objective which is covered at #3
d. discussion on if we need to hire new people, need new tools
e. since this is new, I assume we can review identified risks, we have a risk log, so if I refer to this log, and the actions take, will this be enough?
f. could use an explanation here

The auditor stated we needed to consider the review of strategic plan and quality policy. He pointed us to 'e'.
We had assumed we had every area covered in our procedure, but Im wondering what we are missing. I included an excerpt from our procedure

Thanks for any help that can be provided.
 

Attachments

Laura Halleck

Starting to get Involved
#6
See my comments on your interpretations below:

a. action item review - yes
b. internal could be something like a major equipment failure, external could be getting a specialized contract we need additional training for (I think the interpretation of this one could use more explaining) - this should go back to your internal and external issues identified in section 4.1
c. does anything need to specifically noted here - or move along to 1-8? - this should include review of the effectiveness of each of your key business processes based on performance measures for each process (i.e. meeting targets or not)
1. Survey results, customer complaints, corrective actions and feedback from those we defined as interested parties - in our case, customers, suppliers and employees. - yes
2. reporting of our objectives and are they met, if not what are we doing about it - yes
3. WIP, test and final reporting, high/low defect code, failure rate, etc. - ok
4. we generally put a summary of customer rejections here; if we see a trend of specific rejections, the time it takes to close the rejection - how many opened vs. closed - does this tie to your corrective action system, i.e. is each customer rejection considered a corrective action? Do you have corrective actions other than customer rejects?
5. Tool and calibration - this section is more meant to be about monitoring and measurement of your business process performance (see comment above for part c)
6. Customer, supplier, registrar audits - this should also include internal audits
7. supplier review - yes
8. not sure here - our OTD is an objective which is covered at #3 - ok as long as it's covered somewhere
d. discussion on if we need to hire new people, need new tools - ok
e. since this is new, I assume we can review identified risks, we have a risk log, so if I refer to this log, and the actions take, will this be enough? - you should be tracking whether the actions have reduced the risk level, i.e. your risk log shows a particular risk to be "High", then after the action is taken, it is reassessed as "Med", then it would be considered effective at reducing the risk
f. could use an explanation here - this would be any identified opportunities for improvement from any source, i.e. internal/external audits, suggestions made by any of the business process owners to improve their processes, etc. During the MR, the team reviews these suggestions and identifies any actions that will be taken as a result of those opportunities (9.3.3.a)

A few other thoughts: para. 9.3.1 states "Top management shall review the organization's QMS, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization."

Although the "alignment with the strategic direction" isn't listed as a specific input in section 9.3.2, this may be what your auditor was referring to with regards to considering a review of the strategic plan. I think your procedure leaves it a little unclear as to what you are reviewing the strategic plan for, i.e. it doesn't state that you are reviewing it for alignment between your QMS and the strategic direction of the organization.

As far as the quality policy goes, section 5.1.1.b requires leadership to ensure that the quality policy and quality objectives are established and are compatible with the context and strategic direction of the organization. I didn't see anything to this effect in the excerpt from your procedure.

In general, I suggest people to keep their wording and format for MR inputs and outputs to stay as close as possible to the standard (of course adding in your own organization's interpretations of how it applies to you).

Let me know if you still have questions.
 
#7
Currently, we have been interpreting them as follows:
a. action item review
b. internal could be something like a major equipment failure, external could be getting a specialized contract we need additional training for (I think the interpretation of this one could use more explaining)
c. does anything need to specifically noted here - or move along to 1-8?
1. Survey results, customer complaints, corrective actions and feedback from those we defined as interested parties - in our case, customers, suppliers and employees.
2. reporting of our objectives and are they met, if not what are we doing about it
3. WIP, test and final reporting, high/low defect code, failure rate, etc.
4. we generally put a summary of customer rejections here; if we see a trend of specific rejections, the time it takes to close the rejection - how many opened vs. closed
5. Tool and calibration
6. Customer, supplier, registrar audits
7. supplier review
8. not sure here - our OTD is an objective which is covered at #3
d. discussion on if we need to hire new people, need new tools
e. since this is new, I assume we can review identified risks, we have a risk log, so if I refer to this log, and the actions take, will this be enough?
f. could use an explanation here

The auditor stated we needed to consider the review of strategic plan and quality policy. He pointed us to 'e'.
We had assumed we had every area covered in our procedure, but Im wondering what we are missing. I included an excerpt from our procedure

Thanks for any help that can be provided.
I think you are on track. There is no requirement at management review to review strategic plan or quality policy. This would likely be done at a high level during your planning sessions. Many strategic planning elements are included in management review anyway. All the risk, opportunity, performance results, resources are parts of your strategic plan.
 

ImLost

Starting to get Involved
#8
Laura, thank you for your comments.
I think we will update the procedure to read exactly how the standard reads, and then create a supplemental document using our own words should help management understand the information required.
We recently had upper management request to combine the MR (2 times a year) and a Quality meeting (monthly). Doing a MR monthly is almost overkill with some of these subjects.
I believe I can now explain to them it should not be combined - and cover some stuff monthly, with the report and trend reporting at the MR.
Again, thank you.
 

howste

Thaumaturge
Super Moderator
#9
Laura, thank you for your comments.
I think we will update the procedure to read exactly how the standard reads, and then create a supplemental document using our own words should help management understand the information required.
We recently had upper management request to combine the MR (2 times a year) and a Quality meeting (monthly). Doing a MR monthly is almost overkill with some of these subjects.
I believe I can now explain to them it should not be combined - and cover some stuff monthly, with the report and trend reporting at the MR.
Again, thank you.
There is nothing in the standard that says each input and output needs to be addressed in each MR meeting. You could have an agenda that specifies the reporting frequency for each. Actually the standard doesn't even mention the need to have a meeting, but most companies do.
 
#10
Laura, thank you for your comments.
I think we will update the procedure to read exactly how the standard reads, and then create a supplemental document using our own words should help management understand the information required.
We recently had upper management request to combine the MR (2 times a year) and a Quality meeting (monthly). Doing a MR monthly is almost overkill with some of these subjects.
I believe I can now explain to them it should not be combined - and cover some stuff monthly, with the report and trend reporting at the MR.
Again, thank you.
If you are already doing a regular management get together monthly, I would definitely, absolutely, combine it with "management review." No reason to have yet another meeting. Most of it probably comes up during your regular meeting anyway. Just keep track of what elements you cover. We did this several years ago. I simply carry with me our management review checklist, and when we address a topic I make a note of it. Much more efficient and eyes don't glaze over. Good luck.
 
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