ISO 9001:2008 Clause 8.2.3 Monitoring and Measurement of Processes Help

S

s33d3r

#1
Dear Sir,

I searched this forums through Google and the Posts and discussion elaborated here provide me the basic understanding of the Standard.

Sir, I need your help regarding the Clause 8.2.3.

Recently we had a Re-Certification Audit for ISO 9001:2008. In my Organization Quality Management System is implemented for Software Development. Hence the Core group under scope is the Software Development group. Other than this Admin Department, IT Infrastructure, Quality Section, Business Development forms the Supporting Group for Software Development Department. We have defined Quality Objectives for Software Development and are continuously Recording and Monitoring the Objectives.

The Auditor gave the reference of the Clause 8.2.3 and asked us to Show the Processes and Objectives for the Support Groups. As such we don't have separate documented Processes and Objectives for the supporting groups. A NC has been raised regarding the same for the Clause 8.2.3, 7.1,and 4.2.4.

we have the QMS implemented for the last six years and none of the Auditors have pointed out this thing before.

Please provide your help and elaborate on the requirements of Clause 8.2.3.

Awaiting for your reply.
 
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somashekar

Staff member
Super Moderator
#2
Re: Need Help on ISO 9001:2008 Clause 8.2.3 Monitoring and Measurement of processes

Hii s33d3r... Happy to have you here and welcome to the COVE.
It will do good if we have the exact complete NC statement said here.
All your processes, Core / Supporting need to be monitored and measured in order to ensure that the customer requirements as well as organization requirements are met, and if not, suitably corrected to come on course and then to continually improve.
Its a part of the PDCA cycle. The ISO9001 QMS moves forward on the PDCA
About the objectives, it is entirely up to you (and your management) to determine and establish objectives that would be met by the support processes owners. This improvement step will align with quality polices
 
Last edited:

John Broomfield

Staff member
Super Moderator
#3
Re: Need Help on ISO 9001:2008 Clause 8.2.3 Monitoring and Measurement of processes

Dear Sir,

I searched this forums through Google and the Posts and discussion elaborated here provide me the basic understanding of the Standard.

Sir, I need your help regarding the Clause 8.2.3.

Recently we had a Re-Certification Audit for ISO 9001:2008. In my Organization Quality Management System is implemented for Software Development. Hence the Core group under scope is the Software Development group. Other than this Admin Department, IT Infrastructure, Quality Section, Business Development forms the Supporting Group for Software Development Department. We have defined Quality Objectives for Software Development and are continuously Recording and Monitoring the Objectives.

The Auditor gave the reference of the Clause 8.2.3 and asked us to Show the Processes and Objectives for the Support Groups. As such we don't have separate documented Processes and Objectives for the supporting groups. A NC has been raised regarding the same for the Clause 8.2.3, 7.1,and 4.2.4.

we have the QMS implemented for the last six years and none of the Auditors have pointed out this thing before.

Please provide your help and elaborate on the requirements of Clause 8.2.3.

Awaiting for your reply.
s33d3r,

Monitoring processes (with or without measurement) for their effectiveness and correcting processes as necessary to fulfill objectives and other requirements is what the people working the process and their supervisors do.

This process of monitoring may not be specified by a documented procedure but you may need to per 4.2.1d if your processes are not effectively monitored. No records may arise from monitoring unless your planning deems them essential per 7.1d. Repeated process corrections may result in corrective action to stop recurrence of process nonconformity long before the auditor arrives and of course these would be recorded.

I am not sure why your internal auditors failed to spot and report the lack of process monitoring. Perhaps because the auditors thought they were doing the monitoring? This is a common mistake that leads to a lack of recognition for the importance of supervisory activity which includes process monitoring and coaching the workers to monitor their processes for themselves.

One way to measure the engagement of workers in monitoring their processes is to compare the preventive actions with the corrective actions and to compare the origins of corrective actions. In a mature management system such as yours 80% of the CARs should come from non-audit sources.

Does your management system rely too much on its auditors?

John
 
#4
The Auditor gave the reference of the Clause 8.2.3 and asked us to Show the Processes and Objectives for the Support Groups. As such we don't have separate documented Processes and Objectives for the supporting groups. A NC has been raised regarding the same for the Clause 8.2.3, 7.1,and 4.2.4.
Can you share with us the exact content of the nc? I'm suspicious that this isn't a real issue, since no-one has referenced it before...Mind you, perhaps THEY were wrong not to and weren't doing an effective audit!:popcorn:
 

Big Jim

Super Moderator
#5
I too would like to see the wording of the nonconformance.

Be aware that there is a continuing push more and more toward the process approach. It is in the standard, but it could be clearer, as it is somewhat scattered through the standard.

It helps to be aware of the dual meaning of the word "process". Both meanings are involved with the standard, but to a casual reader they may not recognize it. Most think of processes as production processes, such as how to assembly something, how to solder, how to weld, how to electroplate, how to machine a part, and so on.

What could be clearer is that processes also include your business processes, also sometimes referred to your core processes. Element 4.1 where you need to determine your processes, how they relate to each other, how you will monitor and measure them, and what you will do when they don't measure up seem to be mostly about these business processes.

The portion of 4.1 that deals with outsourcing is more likely to do with product processes although business processes fit here too. 7.5.2 where you need to validate special processes seems to mainly apply to product processes.

ISO isn't of much help here because of the inadequacy of their definition of what a process is. In ISO 9000 they simply define a process as something with inputs and outputs. It is my opinion that until they do a better job with that definition this will remain a ship that is adrift.

Element 5.4 provides some input here in that you need to have quality objectives and that they need to be established at relevant functions and levels in the organization. Although it hasn't always been so, with the push toward the process approach, it is expected today that these be applied to your core processes.

Every company is different, but a common set of core processes might include Sales, Planning, Design, Purchasing, Production, QC, and Administration. Assigning a quality objective or a set of quality objectives to each of these processes has become a common way to meet this.

8.2.3 Tell you that you need to monitor and measure your processes, and using your quality objectives as assigned to your core processes help you to do that. When you use quality objectives to help with monitoring and measuring your processes, they are also often referred to as Key Performance Indicators or KPI. In the ISO realm, often KPI is referred to as Key Process Indicators, and it fits, but the original term came from the business world as Key Performance Indicators.

8.4 provides help on just what those objectives / KPI might be. 8.4 tells you that you need to determine, collect, and analyze data that helps you to know the health of your quality management system and help you improve it. 8.4 goes on to provide four topics that this analysis needs to be done for: customer satisfaction, product quality, process performance, and supplier performance. Keep in mind that a common overall measure of process performance is on-time delivery.

A common set of quality objectives / KPI then could be: customer satisfaction by survey (or some other manner), first pass yield (how many things make it through final inspection without rework or rejection) or some other measure of quality such as re-work or warranty returns, on-time delivery, and supplier rejects (and / or supplier on-time delivery).

How these could be lined up to those typical processes mentioned above could be: Sales - Customer Satisfaction; Planning - On-time Delivery and / or Product Quality; Design - On-time Delivery; Purchasing - Supplier Performance, Production - Product Quality; QC - Product Quality; Administration - All of the KPI with perhaps a stress on Customer Satisfaction.

Keep in mind that Auditors have been directed to look for something like this. Some workbooks even have KPI charts for the auditor to complete. This seems to be the direction that ISO is going to ensure meeting the requirements of mainly 8.2.3.

There seems to be a greater emphasis on the process approach each year so don't expect this to go away. You may encounter some auditors who don't take this as seriously as others, but the general trend has firmly been established.
 
S

s33d3r

#6
Dear All,

I am very much thankful to all for sharing the Information regarding the same.

Auditors will be submitting the report in a day or few and then i will share you the exact NC mentioned in the report.

One more question that comes in my mind is that do all ISO standards say that there has to be a documented Procedure or Documented Process to carry out a work. I mean if we can provide the evidences of a work and we dont have a documented Process for the same will that be acceptable or not.
 

somashekar

Staff member
Super Moderator
#7
The ISO9001 is very clear as to where a documented procedure is requireed. It says " A documented procedure shall be established ~~~ " at every such required place.
For the rest, the ISO9001 claise 4.2.1 d) sets the direction.
d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.
Here you therefore apply a risk based determination to decide to have a documented procedure or not.
 

Big Jim

Super Moderator
#8
"One more question that comes in my mind is that do all ISO standards say that there has to be a documented Procedure or Documented Process to carry out a work. I mean if we can provide the evidences of a work and we dont have a documented Process for the same will that be acceptable or not."

Aditionally, there re six topics in ISO 9001:2008 that require a documented procedure: Control of Documents, Control of Records, Internal audit, Control of nonconforming product, Corrective Action, and Preventive Action.

So specifically to your question, no, the standard does not require a documented procedure or documented process to carry out work. Other than the six required topics, it is up to you as a company to determine if you need a documented procedure or not.
 

John Broomfield

Staff member
Super Moderator
#9
Dear All,

I am very much thankful to all for sharing the Information regarding the same.

Auditors will be submitting the report in a day or few and then i will share you the exact NC mentioned in the report.

One more question that comes in my mind is that do all ISO standards say that there has to be a documented Procedure or Documented Process to carry out a work. I mean if we can provide the evidences of a work and we dont have a documented Process for the same will that be acceptable or not.
s33d3r,

Do not forget the undocumented procedure is included in the definition of procedure. Quite often auditors ask questions to determine the effectiveness of undocumented procedures.

You can ask these questions too and then you'll realize that every procedure does not need to be documented.

Indeed, ISO 9001, clause 4.2.1d requires you to document only the the extent necessary for effective planning, operation and control. Your management system is a lot more than a set of documents.

John
 
S

s33d3r

#10
Hello to all,

Today we have received the Audit Report from the Auditor.

The Exact NC Statement is as follows:

1. Other department related processes are not drafted as per QMS requirements. Quality objectives for supporting departments are not defined (7.1,4.1,1.2)

2. Monitoring and Measurement of supporting processes are not carried out as
there are no formal quality objectives defined. (8.2.3)

Kindly Suggest me out as in how to close these NC's.
 
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