ISO 9001 Clause 9.1 - Monitoring measurement analysis and evaluation

qualprod

Trusted Information Resource
#1
Hello everyone
Could you share something in this point?
I have experienced that most of users and auditors, in this clause are satisfied with little data to take actions, complaints, rejects, supplier evaluation, kpis, and that's all.
The standard asks more actions, identify what to measure, when, how, actions, also to use statistics to analyze data, no doubt some organizations are doing well in this, but some other Don't.
What is your point of view?
Thanks
 
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John Broomfield

Staff member
Super Moderator
#2
qualprod,

It used to be called quality planning. Deciding what to measure, when, with what and by whom. What records are required and what is to happen in case of a nonconformity.

The result was a quality plan and/or inspection and test plans.

Now with the move away from checking the output towards getting the inputs and the processes right, we place more emphasis on mistake-proofing or process design.

Designing a process so the results are right the first time, every time is the ultimate in quality planning.

Such was our investment in the prevention of defects, now increasingly referred to as risk management. Hopefully, we will not use RM logic to replace prevention with more testing and inspection.

As I see it,

John
 

tony s

Information Seeker
Trusted Information Resource
#3
The standard asks more actions, identify what to measure, when, how, actions, also to use statistics to analyze data, no doubt some organizations are doing well in this, but some other Don't.
The evidences that fulfill the requirements in this clause can be demonstrated by various means. Clause 9.1 is applicable to all processes that require monitoring, measurement, analysis and evaluation such as:
  • product quality inspections;
  • materials quality inspections;
  • process stability and capability analysis;
  • measurement systems analysis;
  • customer satisfaction analysis;
  • supplier performance monitoring and evaluation;
  • employee performance appraisal;
  • evaluation of the extent of achievement of the quality objectives;
  • evaluation of the results of audits;
  • review of the suitability, adequacy and effectiveness of the QMS, etc.
 

qualprod

Trusted Information Resource
#4
The evidences that fulfill the requirements in this clause can be demonstrated by various means. Clause 9.1 is applicable to all processes that require monitoring, measurement, analysis and evaluation such as: ....
Yes all that apply, but what I refer to, is that people just comply with kpis, an rarely gather lot of data to analyze, supported with statistics.well is What I have seen, and also , most of auditors don't audit the task of deep analysis.
 

Kronos147

Trusted Information Resource
#5
The new standard is a wide open world in many ways. Context of the organization and relevant interested parties mean a LOT!

(are you big with government contracts and subject to lots of source inspection? Your system needs to be very well documented, and as standard as possible, IMO)

(are you small and sell to one of your subsidiaries? Your documentation should be light, IMO)

The key is to be effective!

If you don't measure the stuff you do on any kind of valid scale, how do you know how strong you are? (Or weak?)

9.1.1 TO ME means basically the same as what they used to teach in business colleges:
S.M.A.R.T.

S = Specific
M = Measureable
A = Attainable
R = Realistic
T = Time bound

Common indicators:
Order Processing metrics (lost business, complaints)
Production metrics (OTD - On Time Delivery, DPPM - Defective Parts Per Million)
Vendor Performance metrics (their OTD and DPPM)
---
Management metrics (IA, CAPA, Effectiveness to address risks and opportinities) BUT MOSTLY - Customer Satisfaction

btw, TO THE DEGREE (see 9.1.2, 9.1.3) that the customer has been satisfied.

I don't know, maybe OTD time DPPM \ 2 is the measurement and the organization decides a scale with green, yellow, red (and some sort of Action/reaction/correction).

Where things happen is out in the open now. Daily objectives on a digital white board, but acted upon only when red, or when reviewed as monthly buckets in management review?

What is effective?

Small shop? Word of mouth and a running log to make sure you dot all the i's and cross all the t's? Maybe that's enough. Annual Management Review for the documented information, in case the owner wants to sell the company some day and the new owner is a reader.
 

Tagin

Trusted Information Resource
#6
Yes all that apply, but what I refer to, is that people just comply with kpis, an rarely gather lot of data to analyze, supported with statistics.well is What I have seen, and also , most of auditors don't audit the task of deep analysis.
What you propose ("gather lot of data to analyze" and "the task of deep analysis") would need to be justified by the particular circumstance. It might be that there is value in making such analyses, but before doing that work, you would want to justify how a particular data-gathering and analysis provide actionable information that would result in improvements for the organization.

Another option might be that you would want to carry out a particular data-gathering and analysis method for a period of time - as an experiment - to see if it provides informative, actionable results. If so, then make that a regular part of your 9.1 activities; if not, then discontinue it.

Data warehouses, data mining, predictive analytics, machine learning, etc. have their place, but the cost and resources involved have to be weighed against the perceived benefits.
 

RoxaneB

Super Moderator
Super Moderator
#7
Yes all that apply, but what I refer to, is that people just comply with kpis, an rarely gather lot of data to analyze, supported with statistics.well is What I have seen, and also , most of auditors don't audit the task of deep analysis.
There is no specific requirement for this "deep analysis" you've mentioned. However, the requirements they do audit can be heavily reliant on such an activity occurring. In my experience, they do look at how we do the planning and goal setting, which does often lead us down the path of how we do our analysis. The auditors do not check our math or correct our interpretations, but rather try to understand our "story."
 
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