Differences between Clauses 7.5, 8.2.3 and 8.2.4 of ISO 9001

[qahardlife]

I would like to know what are the difference between these 3 clauses when it comes to auditing a production line?

Lets say we found monitoring and measurement activities is not carried accordingly to planned arrangement, which clause should we use? 7.5 or 8.2.3?

Is 8.2.4 more for QA activities?

7.5 Control of production and service provision
8.2.3 Monitoring and measurement processes
8.2.4 Monitoring and measurement of product

 

[somashekar]

Re: Clause 7.5, 8.2.3 and 8.2.4

Internal Audit ... ?
You audit your process and find if they are performed per plan (Standards requirements + your procedures) and that they are effective., OR you find some deficiencies, either in plan and execution, or some lack of effectiveness.
Then you report the same with proper examples such that appropriate corrective actions can be taken by the responsible personnel., and later look for its effectiveness.
Map your processes to the standard requirement.
Audit your processes.
Continually improve your processes.
Do not map your audit to the standard clauses.
Clauses are in the standard per good documentation practice. CB audit have other requirements to map to standard. You do not force yourself to copycat that.
Instead take all the positives from the CB audit process / style and translate them into your audit process effectively.

8.2.4 is QA activity if you have so defined.

 

[qahardlife]

Re: Clause 7.5, 8.2.3 and 8.2.4

I find 7.5 is on planning stage and 8.2.3 and 8.2.4 more on operational stage.

so if the process on operational level (8.2.3 and 8.2.4) is not going according to plan (7.5), so the nonconformance is at 8.2.3 and 8.2.4?

When I plan my audit, I map out my process flow, determine what I want to audit at each process and then map my procedures and standards onto my audit plan.

 

[Big Jim]

Re: Clause 7.5, 8.2.3 and 8.2.4

Good question.

7.5.1 is likely the best choice. 7.5.1 is control of production, production needs to take place under controlled conditions. Although there is a list of topics that may fail in 7.5.1 a-f, anything that interferes with production control is fair game to write a nonconformance for.

Generally speaking, 8.2.3 mainly refers to your core processes or business processes. I don't know what yours are, but common ones may be management, sales, production planning, purchasing, and production. What seems to be expected today is that your quality objectives or other indicators are used to monitor those processes. When one of them isn't functioning as expected, you are expected to take corrective action. There is a lack of clear definition in the standard as to just what they mean when the word processes is used.

At times, they are talking about those core processes as mentioned above, and at times they seem to be talking about product manufacturing processes such as how to assemble a part, how to solder, how to machine a part, and so on. Element 4.1 seems to be mainly talking about the business processes until you get down to outsourcing where it could be either one or both. 7.5.2 seems to be mainly about product manufacturing processes, those that you cannot tell the outcome from ordinary verification so you need to validate it. Examples of things that usually fall into 7.5.2 include welding, soldering, brazing, plating, and heat treating.

5.4.1 on quality objectives where it talks about them being established at relative functions and levels in the organization seems to be talking about monitoring the business processes.

8.2.4 deals with inspection.

I hope this helps.

 

[qahardlife]

Re: Clause 7.5, 8.2.3 and 8.2.4

so for production, what kind of process falls under 7.5 and what kind of process falls under 8.5.2?

8.5.4 is it for QA inspection or for production inspection?

 

[John Broomfield]

Re: Clause 7.5, 8.2.3 and 8.2.4

I would like to know what are the difference between these 3 clauses when it comes to auditing a production line?

Lets say we found monitoring and measurement activities is not carried accordingly to planned arrangement, which clause should we use? 7.5 or 8.2.3?

Is 8.2.4 more for QA activities?

7.5 Control of production and service provision
8.2.3 Monitoring and measurement processes
8.2.4 Monitoring and measurement of product

qahardlife,

Most if not all nonconformity can be cited against more than one clause.

Choose the clause (requirement) that best directs the corrective action.

...and that depends on the evidence.

John

 

[Big Jim]

Re: Clause 7.5, 8.2.3 and 8.2.4

so for production, what kind of process falls under 7.5 and what kind of process falls under 8.5.2?

8.5.4 is it for QA inspection or for production inspection?

7.5 includes 7.5.1 Control of production
7.5.2 Valadation of "special processes"
7.5.3 Identification and Traceability
7.5.4 Contorl of Customer Property
7.5.5 Preservation of Product

I'll only speak to 7.5.1 as it would be lenghtly to try to answer for the others and I think your question is mostly about 7.5.1.

Business process wise, the process that 7.5.1 deals with is whatever you call your production or manufacturing group of activities.

Product process wise, typical processes may includie machining, soldering, welding, painting, assembly, and any other manufacturing type of activity.

8.5.2 is Corrective Actions, and doesn't seem to fit this conversation.

8.5.4 doesn't exist, the standard ends at 8.5.3.

 

[Sidney Vianna]

Lets say we found monitoring and measurement activities is not carried accordingly to planned arrangement, which clause should we use? 7.5 or 8.2.3?

While you can find different homes for the nonconformity, in this case, based on what you described, the best one is 7.5.1 e)

The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable,

e) the implementation of monitoring and measurement, and

 

[AndyN]

I would like to know what are the difference between these 3 clauses when it comes to auditing a production line?

Lets say we found monitoring and measurement activities is not carried accordingly to planned arrangement, which clause should we use? 7.5 or 8.2.3?

Is 8.2.4 more for QA activities?

7.5 Control of production and service provision
8.2.3 Monitoring and measurement processes
8.2.4 Monitoring and measurement of product

Are they process or product? I'd suggest you don't record the issue against an ISO clause since management don't speak that language. You (or the MR) can "know" which it is, but for everyone else, refer to whatever is the affected internal QMS document. Frankly, citing an ISO clause is, for most people, talking a foreign language...