Management Review Inputs ISO9001

Michael_M

Trusted Information Resource
#1
Ok, I took about 1 1/2 years off from Quality Management and now that I have come back I found I have forgotten some minor things: Most of the time I can re-educate myself and get back up to speed, but this one is throwing me off:

9.3.2 Management Review Inputs
C5. Monitoring and Measurement results

For some reason I keep going back that this is the same thing as quality objectives but those were addressed earlier. What am I over thinking here? What are the specifics that are monitored and measured other than the Key performance indicators/quality objectives?

Edit: Added C5 to reference proper section
 
Last edited:
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AMIT BALLAL

Super Moderator
#2
It can include:
- KPIs/Quality objectives/Effectiveness & efficiency measures
- Customer Satisfaction survey/Index scores
- Customer Scorecards
- Supplier rating
etc.
 

John Broomfield

Staff member
Super Moderator
#3
Some suggested inputs to Management Review

Basically, top management need to see the System Manager’s report on system performance so they can make wise investment decisions:

A. What the system does well (supported by objectives met and by audit results), and
B. What the system does less than well (supported by objectives not met, audit results, feedback from employees, suppliers and customers), and
C. Upcoming challenges (technological, regulatory and market trends), and
D. Recommended system improvements (costed with expected payback).

BTW, the System Manager may be called the QA Manager, Quality Manager or Management Rep..
 
#5
Ok, I took about 1 1/2 years off from Quality Management and now that I have come back I found I have forgotten some minor things: Most of the time I can re-educate myself and get back up to speed, but this one is throwing me off:

9.3.2 Management Review Inputs
C5. Monitoring and Measurement results

For some reason I keep going back that this is the same thing as quality objectives but those were addressed earlier. What am I over thinking here? What are the specifics that are monitored and measured other than the Key performance indicators/quality objectives?

Edit: Added C5 to reference proper section
You are experiencing difficulty due to a poorly written section of the standard. Some of the topics in the inputs list are redundant. I can picture that the committee members had conflicts as to how to word certain parts and what should be included and what should not be included. At the very least it has the earmarks of a compromise attempting to satisfy different factions. The inputs list certainly could and should have been written in a clearer manner.
 

Tagin

Trusted Information Resource
#6
For some reason I keep going back that this is the same thing as quality objectives but those were addressed earlier. What am I over thinking here? What are the specifics that are monitored and measured other than the Key performance indicators/quality objectives?
For each row, the item to be reviewed will have data that you should already be capturing in your QMS, so it just a matter of identifying how you do it, and using that as your review data. Separating all 9.3.2 bullets into separate rows will make it much easier to see where data is being reviewed.

Just make a sheet with 3 columns:
  • Input (these will be 9.3.2 a-f, breaking out c1 - c7 into separate rows)
  • Data Reviewed
  • Notes/Actions to take

For example for 9.3.2a, the row will be something like:
  • Status of actions from previous management reviews;
  • Task status from prior mgmt review
  • Open tasks are proceeding and on-time, etc.
For c7, it'd be something like:
  • The performance of external providers
  • Quarterly supplier reviews & SCARs issued
  • All suppliers meeting criteria except supplier #1234. This supplier was issued SCAR #2345 and the supplier is responding with their plan to correct the issue.
So, for c5, it'd be something like:
  • Monitoring and measurement results
  • Monthly KPI Reviews
  • All KPIs within range except KPI abcd. This KPI deficiency is being addressed on corrective action #9876.
 

Kronos147

Trusted Information Resource
#7
My understanding of the standard is that it talks about what needs to be done in little bits and pieces of the text.

One reading might go like this:

"ISO 9001:2015
4.4.1 The organization shall establish, implement, maintain, and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.

The organization shall determine the processes needed..., and shall:...
c. determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;...

9. PERFORMANCE EVALUATION
9.1 Monitoring, Measurement, Analysis, and Evaluation
9.1.1 General
The organization shall determine:
a. what needs to be monitored and measured;...

9.1.3 Analysis and Evaluation
The organization shall analyze and evaluate appropriate data and information arising from monitoring and measurement.

The results of analysis shall be used to evaluate:
a. conformity of products and services;
b. the degree of customer satisfaction;
c. the performance and effectiveness of the quality management system;
d. if planning has been implemented effectively;
e. the effectiveness of actions taken to address risks and opportunities;
f. the performance of external providers;..."

There are specific things you need to look at including processes metrics, customer satisfaction, conformity of product\service (DPPM?), External Suppliers, but beyond that, 9.1.1 says you determine what needs to be looked at beyond that, or which of your processes you need to measure, and which you don't.

I would also remind all that many of our customer demand performance to on time delivery goals. If this is true, the organization needs to measure on time delivery then, as well.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#8
Customers are your harshest critics and their feedback is critical. As much as negative feedback needs to be vetted and addressed, positive feedback needs to be understood and preserved.

Customers are also internal. Design, production, shipping receiving, sales and marketing. purchasing and accounting.

From the standard

The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable results.

Management review should provide a raw unfiltered view of the company's performance. Its like a performance review for the company.

I would add a part of MR to COVID-19. Never before have I experienced a 22-month long global crisis that has impacted every company from purchasing, sales, production, shipping, employee retention, and training. We are post-vaccine for almost 12 months and it's still a major impact force. Are your objectives realistic with the current global perspective? COVID-19 and its persistence is a threat to your company most likely.
 
#9
Customers are also internal. Design said:
The standard doesn't say anything about internal customers so be careful of this approach. It can be useful but there are no shalls attached.

The PDCA cycles (also known as the Deming Wheel) is a wonderful tool, but again be careful. The shalls don't start until Section 4 and this is in Section 3.
 
#10
My understanding of the standard is that it talks about what needs to be done in little bits and pieces of the text.

One reading might go like this:

"ISO 9001:2015
4.4.1 The organization shall establish, implement, maintain, and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.

The organization shall determine the processes needed..., and shall:...
c. determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;...

9. PERFORMANCE EVALUATION
9.1 Monitoring, Measurement, Analysis, and Evaluation
9.1.1 General
The organization shall determine:
a. what needs to be monitored and measured;...

9.1.3 Analysis and Evaluation
The organization shall analyze and evaluate appropriate data and information arising from monitoring and measurement.

The results of analysis shall be used to evaluate:
a. conformity of products and services;
b. the degree of customer satisfaction;
c. the performance and effectiveness of the quality management system;
d. if planning has been implemented effectively;
e. the effectiveness of actions taken to address risks and opportunities;
f. the performance of external providers;..."

There are specific things you need to look at including processes metrics, customer satisfaction, conformity of product\service (DPPM?), External Suppliers, but beyond that, 9.1.1 says you determine what needs to be looked at beyond that, or which of your processes you need to measure, and which you don't.

I would also remind all that many of our customer demand performance to on time delivery goals. If this is true, the organization needs to measure on time delivery then, as well.

It is my belief that you can easily use on-time delivery to fulfill 9.1.3 c. It is one of the best indicators of how the organizations is performing overall.
 
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