MR Inputs (9.3.2) - "Monitoring and Measurement Results" vs. "Process Performance"

W

wny4ever

#1
#1
Referring to this clause 9.3.2, what is the difference between "monitoring and measurement results" and "process performance"?

9.3.2 Management review inputs
The management review shall be planned and carried out taking into consideration:
c) information on the performance and effectiveness of the quality management system, including trends in:
3) PROCESS PERFORMANCE and conformity of products and services;
5) MONITORING AND MEASUREMENT RESULTS;
 
Paper to QMS ad
Elsmar Forum Sponsor
Jen Kirley

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
#2
Re: MR Inputs (9.3.2) - "monitoring and measurement results" vs. "process performance

The key word to consider is "trends." Up until now we have often only looked at periodic "snap shots" in Management review.

Process performance is in-process, some look at it in terms of cpK but it can also just be trendlines in the process's ability to generate that which it was intended to do. I usually think of proces performance as management/service processes that deliver to the customer.

Monitoring and measurement results sends us back to 9.1.1, which requires us to determine what is to be monitored and measured above and beyond production processes and the items specifically listed, such as audit results (in terms of more than "X audits planned, X audits completed").

Monitoring and measurement does not need to always be of the same things. Suppose there was a project to reduce the amount of time needed to initiate, approve and finalize a document change. There could be a measurement of that time; it could be trended and reported in Management review because of its status as a project. If that metric is important enough to an organization, it could be continued.

I hope this makes sense!
 
W

wny4ever

#3
#3
Re: MR Inputs (9.3.2) - "monitoring and measurement results" vs. "process performance

Thank you for your response, Jen. However, it doesn't answer my question. Both of those MR input requirements are included in 9.3.2.c, which is under the "including trends" statement.
 
Jen Kirley

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
#4
Re: MR Inputs (9.3.2) - "monitoring and measurement results" vs. "process performance

I am sorry for the delay in answering you. I also think I did a poor job in explaining myself.

ISO 9000:2015 (the updated definitions standard) defines performance as a measurable result (the word "result" unhelpfully adding to the confusion) and adds a note that it can be quantitative or qualitative, and a second note that it can can relate to the management of activities, processes, products, services, systems or organizations.

So we can think of 9.3.2c3 as a reporting of output of the "Do" phase in the process approach, where processes are actually running.

9.3.2.c5 uses the same terminology found in 9.1.1, in which the organization determines (a) what needs to be monitored and measured, as well as the (b) methods for monitoring and measurement, plus analysis and evaluation and (d) when the results are analyzed and evaluated. This is the "Check" (or "Study", for Deminguites) phase of the process approach.

So, in 9.3.2.c5 Management is now looking at results. What are the performance data telling us? ISO 9001:2015 uses the term result throughout but ISO 9000:2015 does not define result, so I referred to the Free Dictionary online which defines result as
1. a. Something that follows naturally from a particular action, operation, or course; a consequence or outcome. See Synonyms at effect.
b. results Favorable or desired outcomes: a new approach that got results.

2. Mathematics The quantity or expression obtained by calculation.
Click to expand...
All of this fancy explanation could be boiled down to a simple expression: performance is how something goes, whereas a result is an outcome.

I hope this makes sense!
 
S

Scott.Hilton

Starting to get Involved
#5
#5
Re: MR Inputs (9.3.2) - "monitoring and measurement results" vs. "process performance

I'm actually looking into this as well, I'm not sure why 5 has it's own category on this.

What is unique about 5?

-Cover customer satisfaction trends in 1
-cover Quality objectives in 2
-Cover process performance and conformity in 3
-NCR and Corrective action in 4
-Audit results in 6
-Supplier performance in 7

If we discuss the metrics and results along with actions in 1-4 and 6-7, then what exactly is 5 for?
 
Jen Kirley

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#6
#6
Re: MR Inputs (9.3.2) - "monitoring and measurement results" vs. "process performance

Input #5 is for results of monitoring and measurement, which refers to what we set up in 9.1.1 and analyzed in 9.1.3. It is at the process level, showing management what process level people have already seen: the results indicated by measurements that indicate the degree/extent to which operational controls put in place are effective. A process may have a number of these types of measurements, which can be rolled up in an analysis (9.1.3) to arrive at process performance.

It would have helped, I think, if the input points were in a different order.

Let's keep in mind there is no definition of how often management reviews take place, or that everything needs to be reviewed at once. The standard seems to imply it will be a high level meeting, but a yearly look at inputs #3 and #5 arguably should not wait until the end of the year. There are probably ops reviews or similar, done even on a monthly basis, in which these are reviewed in order to generate a timely and appropriate response if needed.
 
Last edited:
S

Scott.Hilton

Starting to get Involved
#7
#7
Re: MR Inputs (9.3.2) - "monitoring and measurement results" vs. "process performance

Jen Kirley said:
Input #5 is for results of monitoring and measurement, which refers to what we set up in 9.1.1 and analyzed in 9.1.3. It is at the process level, showing management what process level people have already seen: the results indicated by measurements that indicate the degree/extent to which operational controls put in place are effective. A process may have a number of these types of measurements, which can be rolled up in an analysis (9.1.3) to arrive at process performance.

It would have helped, I think, if the input points were in a different order.

Let's keep in mind there is no definition of how often management reviews take place, or that everything needs to be reviewed at once. The standard seems to imply it will be a high level meeting, but a yearly look at inputs #3 and #5 arguably should not wait until the end of the year. There are probably ops reviews or similar, done even on a monthly basis, in which these are reviewed in order to generate a timely and appropriate response if needed.
Click to expand...
So what I think I am getting to is essentially setting up a report out for sections 1-4 and 6-7 that includes: Goal (Input), Results (measurements/trends) and actions as required (output) based upon that input/measurements. If we do that, at least from what I am seeing, we are covering the intent of .5.

I think I think at least.........
 
Jen Kirley

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#8
#8
Re: MR Inputs (9.3.2) - "monitoring and measurement results" vs. "process performance

Scott.Hilton said:
So what I think I am getting to is essentially setting up a report out for sections 1-4 and 6-7 that includes: Goal (Input), Results (measurements/trends) and actions as required (output) based upon that input/measurements. If we do that, at least from what I am seeing, we are covering the intent of .5.

I think I think at least.........
Click to expand...
It may finally be time to establish balanced scorecards on a wider basis, if it helps - please remember the standard does not require a balanced scorecard; I just find their structure could be helpful in sorting out the strategic from the tactical. One could argue that a single, well-crafted scorecard could represent all of the expectations of 9.3.2 inputs #2, #3, and #5. There are a number of books on the subject - I have Kaplan's and found it was a good read but lacked examples. Luckily we have lots of examples to review, to help understand how these data might be arranged to show how they support the organization's overall strategic objectives.
 
Last edited:
S

Scott.Hilton

Starting to get Involved
#9
#9
Re: MR Inputs (9.3.2) - "monitoring and measurement results" vs. "process performance

Jen Kirley said:
It may finally be time to establish balanced scorecards on a wider basis, if it helps - please remember the standard does not require a balanced scorecard; I just find their structure could be helpful in sorting out the strategic from the tactical. One could argue that a single, well-crafted scorecard could represent all of the expectations of 9.3.2 inputs #2, #3, and #5. There are a number of books on the subject - I have Kaplan's and found it was a good read but lacked examples. Luckily we have lots of examples to review, to help understand how these data might be arranged to show how they support the organization's overall strategic objectives.
Click to expand...
And I think that may be what is causing me the issue, our objectives and report outs are already structured very close to that type of format. So if I use the existing format and ensure to add actions to those report outs, then I am ensure the "results" have associated action as appropriate.

Really appreciate the soundboard on this one
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
G ISO 17025-2017 Management Review reporting items - Inputs ISO 17025 related Discussions 1
J Design file for pre-existing products - Inputs and Outputs ISO 13485:2016 - Medical Device Quality Management Systems 5
K Process Mapping - Inputs/Outputs/Detail Activities/Control points/Measurement? Process Maps, Process Mapping and Turtle Diagrams 4
C Design Control - Ways of capturing inputs from manufacturing Other Medical Device Related Standards 5
M Inputs on definition of very similar processes for multi site audit sample - IAF MD1 2018 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
V Sequence of performing risk assessment: User_FMEA (User Errors) vs Design Inputs FMEA and Control Plans 1
R ISO 9001:2015 9.3 - Required inputs to the management review - Audit Nonconformance Manufacturing and Related Processes 14
D Are detailed engineering requirements Design Inputs or Design Outputs 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 14
K IATF16949 inputs/outputs & KPIs Internal Auditing 3
Ajit Basrur Are inputs to the nonconformance process required to be identified? Nonconformance and Corrective Action 21
M IATF 16949 - Cl. 8.3.3 - Product design inputs, manufacturing process design inputs IATF 16949 - Automotive Quality Systems Standard 4
I Trying to explain some of the Management Review Inputs (AS9100D) Management Review Meetings and related Processes 10
B IATF 16949 Clause 9.3.2.1 - Management Review Inputs IATF 16949 - Automotive Quality Systems Standard 1
B IATF 16949 Cl. 9.3.2.1 - Management Review Inputs - Process Effectiveness and Efficie IATF 16949 - Automotive Quality Systems Standard 14
A Difference between requirement for 4.4.1a (inputs) and 4.4.1d (resources needed)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A ISO 9001:2015 Clause 9.3.2 - Management Review Inputs must be Documented? Management Review Meetings and related Processes 15
dubrizo IATF 16949 Clause 8.7.1.6 - Customer Notification - Your Inputs Requested IATF 16949 - Automotive Quality Systems Standard 4
A SIPOC (Suppliers Inputs Process Outputs Customers) examples wanted Quality Manager and Management Related Issues 1
L Identification of Inputs vs. Outputs in Design and Development (Section 7.3) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Design Inputs - Final Medical Device Specifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
J Design Inputs and Verification Activities CE Marking (Conformité Européene) / CB Scheme 5
C Required Management Review Inputs List Management Review Meetings and related Processes 10
Crusader What are the CB's inputs and deliverables at Stage 1? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
S Cost Targets as Design Inputs in your DHF (Design History File) US Food and Drug Administration (FDA) 7
K Interpreting and Applying 7.3.2 Design and Development Inputs ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Sampling Inspection at QA - Inputs on the following sampling plan Statistical Analysis Tools, Techniques and SPC 2
J Names of Inputs and Outputs in Octopus Diagrams IATF 16949 - Automotive Quality Systems Standard 3
R Process to use Special Characteristics as FMEA Inputs IATF 16949 - Automotive Quality Systems Standard 3
S AS9110B ? Product Safety Inputs to Management Review AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
K Are Nonconformance inputs to the product also NC product? Nonconformance and Corrective Action 11
Q Management Review Inputs - Production Site under a Corporate Certification Scheme Management Review Meetings and related Processes 9
Q How to read and interpret an SIPOC (Suppliers Inputs Process Outputs Customers) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R Risk Assessment Matrix Question - Inputs from the DFMEA, etc. FMEA and Control Plans 9
R Software System Inputs and Outputs - IEC 62304 5.2.2 - Software Requirements Content IEC 62304 - Medical Device Software Life Cycle Processes 6
Q Design Inputs Document Content Design and Development of Products and Processes 20
F Failure Modes for Public Transport Vehicle Door Assembly - Your inputs please! FMEA and Control Plans 27
C ISO 17025 Testing Laboratory Management Review Inputs ISO 17025 related Discussions 2
E SIPOC (Suppliers Inputs Process Outputs Customers) Feedback & Example to share Process Audits and Layered Process Audits 12
Chennaiite DFMEA (Design FMEA) at Vehicle Level - Some inputs needed. FMEA and Control Plans 4
S Definition Inputs vs. Resources in the context of a Process - Differences Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 21
M SIPOC (Suppliers Inputs Process Outputs Customers) Process Mapping Tool example Process Maps, Process Mapping and Turtle Diagrams 11
Z SIPOC (Suppliers Inputs Process Outputs Customers) Chart Training Material ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Management Review Inputs (Process Performance) Management Review Meetings and related Processes 16
O Management Review Inputs and Outputs - AS9100 Registration Audit Requirements Management Review Meetings and related Processes 16
S Design Trace Matrix Ensuring that Design Outputs meet Design Inputs wanted 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
B Quality Planning process map - Struggling to define all the inputs and outputs Process Maps, Process Mapping and Turtle Diagrams 17
P Inputs vs. Output: How to check dependence? Six Sigma 11
S Sources of Nonconforming Products - Inputs to the nonconforming goods process Nonconformance and Corrective Action 1
D 7.3.2 Design and Development (trade licenses) Inputs Record - Example wanted Design and Development of Products and Processes 2
D Inputs, outputs, targets, resources, and activities of Control of Documents process Document Control Systems, Procedures, Forms and Templates 1
Similar threads
Top Bottom