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Process Measurement - ISO 9001:2008 Clause 8.2.3 - Whats your Interpretation

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lennon121

#1
Dear All,

I am new to this forum so firstly I would like to say hello before I rabbit on about system requirements etc etc etc.

I am currently studying a BSI diploma in Quality management and throughout the course I have found this a revelation in learning business skills and the way in which we control our business needs, however I am currently on a module which by my understanding has opened a very large can of worms! My end desire is to build into my business flowchart the process control systems within the business, at first I though this was quite simple adding in data control points, Quality control processes etc etc however when I looked more in to this it became apparent that there was more to this than meets the eye. My question to you is:
ISO 9001:2008 clauses 8.2.3 - Whats your Interpretation and how do you measure your processes?

Thanks

Lennon121
 

somashekar

Staff member
Super Moderator
#2
Re: ISO 9001:2008 clauses 8.2.3 - Whats your Interpretation

Dear All,

I am new to this forum so firstly I would like to say hello before I rabbit on about system requirements etc etc etc.

I am currently studying a BSI diploma in Quality management and throughout the course I have found this a revelation in learning business skills and the way in which we control our business needs, however I am currently on a module which by my understanding has opened a very large can of worms! My end desire is to build into my business flowchart the process control systems within the business, at first I though this was quite simple adding in data control points, Quality control processes etc etc however when I looked more in to this it became apparent that there was more to this than meets the eye. My question to you is:
ISO 9001:2008 clauses 8.2.3 - Whats your Interpretation and how do you measure your processes?

Thanks

Lennon121
While 8.2.4 says about all the monitoring and measurement requirements of mostly what happens under clause 7, this (8.2.3) broadly addresses monitoring and measurement of other processes as mentioned in clause 4 thru 6. Now what are these processes?
1. The establishing of the Quality policy and Objectives
2. The establishment of the Quality manual
3. The control of documents
4. The control of records
5. The process of defining, documenting and communicating responsibility and authority
6. The management rep appointment
7. The establishment of internal communication
8. The conducting of the management review
9. The determining and provision of human resource, Infrastructure and work environment
So if you view this in the PDCA cycle, it is the checking activity (monitoring and measurement) of the PLAN in order to take appropriate ACTION as the PDCA cycle progresses.
The standard lets you determine the method keeping in view the product requirements. So you have the liverage to determine your monitor and measure method.
Results of internal audits are perhaps one of the best and most widely used measuring method. (Only that the Internal audits must be conducted in its true spirits)
 
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#3
Re: ISO 9001:2008 clauses 8.2.3 - Whats your Interpretation

Measuring your process can be done by establishing objectives for each process. Also when you are performing the internal audit, you are monitoring and measuring your processes.
 
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U

Umang Vidyarthi

#4
Re: ISO 9001:2008 clauses 8.2.3 - Whats your Interpretation

Dear All,

I am new to this forum so firstly I would like to say hello before I rabbit on about system requirements etc etc etc.

I am currently studying a BSI diploma in Quality management and throughout the course I have found this a revelation in learning business skills and the way in which we control our business needs, however I am currently on a module which by my understanding has opened a very large can of worms! My end desire is to build into my business flowchart the process control systems within the business, at first I though this was quite simple adding in data control points, Quality control processes etc etc however when I looked more in to this it became apparent that there was more to this than meets the eye. My question to you is:
ISO 9001:2008 clauses 8.2.3 - Whats your Interpretation and how do you measure your processes?

Thanks

Lennon121
Hello Lennon :bigwave:Welcome to the cove:bigwave:

8.2.3 Monitoring and measurement of process: The organisation shall apply suitable methods for monitoring and, where applicable, measurement of quality management system process. These methods shall demonstrate the ability of the process to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken , as appropiate.

NOTE When determining suitable methods, it is advisable that that the organisation consider the type and extent of monitoring and measurement appropiate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the QMS
Since your querry is about 'measurement' of the process, the term 'where applicable' leaves the decision to the management. Similarly, in the note, the decision to decide 'the type & extent of monitoring and measurement' is again left to the management.

In the nutshell, with no hard and fast rules, the entire decision is left in the hands of management, with the rider that these methods have the ability of the process to achieve desired results.

Hope this helps

Umang :D
 
#5
I wish to add another dimension to this discussion.

Remember first that ISO 9001 pushes the process approach. You are told to determine or identify the processes needed to have an effective quality management system, determine the sequence and interaction of those processes, and to monitor, and where applicable, measure those processes. This is all in the beginning of the standard, in 4.1.

4.2.2 tells you that you need to describe the interaction between your processes as part of your quality manual.

Ideally then, you should be able to refer to your interaction of processes chart or description and identify your processes. It is critical that you do this part properly. If you have done a lousy job of identifying them, you will struggle with the rest. Perhaps that is another topic.

So list those processes. Not necessary all the sub-processes in minute detail, but the core processes. Likely there are about eight or ten of them, and it may help to think along departmental lines.

How do you monitor and measure them? A common way is with quality objectives and/or key performance indicators. Select an objective or indicator for each core process. Make sure it is measurable. Track that indicator on a periodic basis (monthly, quarterly, annually, whatever makes sense for that metric). Any one indicator may be used for more than one process.

A partial clue can be had from element 8.4 where you are told to determine, collect, and analyze data to provide insight about the health of your quality management system. It goes on to provide a minimum of four areas that you must perform this analysis for: customer satisfaction, product quality, process performance, and supplier performance. Include trend charts showing how each of these metrics perform from period to period.

Some examples could be: customer satisfaction of 95% or higher from an annual survey, first pass yield of final inspection of at least 98%, on-time delivery of at least 95%, and rejects of supplier material at receiving of less that 2%.

So take what you have to do for 8.4 and align it with your processes. A typical organization may break out as follows: Sales - Customer Satisfaction, Planning/Scheduling - On-time Delivery, Purchasing - Supplier Performance, Production - Product Quality, and so on.

This use of quality objective / key performance indicators is part of what make ISO 9001 such a powerful management tool if applied effectively.

Gotta run. I don't want to be late for today's assignment.
 
#6
Re: ISO 9001:2008 clauses 8.2.3 - Whats your Interpretation

Measuring your process can be done by establishing objectives for each process. Also when you are performing the internal audit, you are monitoring and measuring your processes.
While I agree, I would like to take this one step farther. If we want our processes to be both effective and efficient, we need some way for the process owner (and process operators) to know how the process is operating. In order to do this, each process needs to have some sort of metrics. This is routinely done on an informal basis. What we need to do is to look at our processes to determine which metrics (if any) need to be formally measured. That measurement (which is reflected in 8.2.3) will also be a critical component in Analysis of Data (8.4), Continual Improvement (8.5.1) and also needs to be reflected in Management Review (5.6).
 
L

lennon121

#7
Ok thanks people, I just wanted to make sure I wasn't to far of the mark by getting some expertise from this sight.

So the main question now is how do you constuct a business flow chart
which includes all of these activities, or don't you?

Any examples would be good.

Thanks again.
 
#8
Ok thanks people, I just wanted to make sure I wasn't to far of the mark by getting some expertise from this sight.

So the main question now is how do you constuct a business flow chart
which includes all of these activities, or don't you?
I'm not sure that I would construct a business flow for process measurement. I think I would just make sure that process monitoring and measurement is part of the process flow. Also, that process metrics are incorporated in your management review process flow.
 
S

sathishthantri

#9
I wish to add another dimension to this discussion.

Remember first that ISO 9001 pushes the process approach. You are told to determine or identify the processes needed to have an effective quality management system, determine the sequence and interaction of those processes, and to monitor, and where applicable, measure those processes. This is all in the beginning of the standard, in 4.1.

4.2.2 tells you that you need to describe the interaction between your processes as part of your quality manual.

Ideally then, you should be able to refer to your interaction of processes chart or description and identify your processes. It is critical that you do this part properly. If you have done a lousy job of identifying them, you will struggle with the rest. Perhaps that is another topic.

So list those processes. Not necessary all the sub-processes in minute detail, but the core processes. Likely there are about eight or ten of them, and it may help to think along departmental lines.

How do you monitor and measure them? A common way is with quality objectives and/or key performance indicators. Select an objective or indicator for each core process. Make sure it is measurable. Track that indicator on a periodic basis (monthly, quarterly, annually, whatever makes sense for that metric). Any one indicator may be used for more than one process.

A partial clue can be had from element 8.4 where you are told to determine, collect, and analyze data to provide insight about the health of your quality management system. It goes on to provide a minimum of four areas that you must perform this analysis for: customer satisfaction, product quality, process performance, and supplier performance. Include trend charts showing how each of these metrics perform from period to period.

Some examples could be: customer satisfaction of 95% or higher from an annual survey, first pass yield of final inspection of at least 98%, on-time delivery of at least 95%, and rejects of supplier material at receiving of less that 2%.

So take what you have to do for 8.4 and align it with your processes. A typical organization may break out as follows: Sales - Customer Satisfaction, Planning/Scheduling - On-time Delivery, Purchasing - Supplier Performance, Production - Product Quality, and so on.

This use of quality objective / key performance indicators is part of what make ISO 9001 such a powerful management tool if applied effectively.

Gotta run. I don't want to be late for today's assignment.
I fully agree with Big Jim and am aligned to this interpretation of the standard.

There are many metrics through which you measure processes - some examples are given already. Metrics like hit rate of your tenders, %ge lost orders, hit rate on the production / despatch plans, OEE, downtime of bottleneck activities, supplier on time delivery, on time delivery of products, number of design errors, number of test errors, absenteeism rate, attrition rate, accident metrics, customer (dis)satisfaction index, missed (planned) trainings, employee (dis)satisfaction index, incoming quality performance, sourcing savings, invoicing errors, process efficiency savings, no. of thefts in the site, no. of delayed projects, no. of employees overstaying after the office hours, no. of disturbances in the production process. ........ with objectives for the month / year will provide an insight of the process performance.

The effects will be known by measuring but how many organisations take actions on the causes is a question mark.

The measurement of the some specific identified metrics (and subsequent actions to prevent recurrence) is the ideal way to continually progress with efficiency.

Sathish
 
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lennon121

#10
Thanks DB, you say you would make process monitoring part of your process flow which is what I actually meant in my post. How would you document this, my original process flow was a vertical flow of my organisation but now I need to add process control steps to it.

Do I a) Continue with the vertical flow adding in process control points (or)
b) Start the process flow again horizontally adding in decision points
as process control points (or)
c) Something else.
 
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