Clause 4.4.1 c) vs. Clause 9.1.1

Orca1

Involved In Discussions
Clause 4.4.1 (c) requires organizations to have a method for ensuring the effective operation and control of all processes, not necessarily a KPI for each one. For support processes, alternative methods such as logs or records can be used.
 

Randy

Super Moderator
Or are you saying, even though the organization determined a process, they don't have to determine a measurement for that process?
Sorta, and forgive me when I say "there has to be some common sense applied". Each and every "process" within an organization, within a MS truly escapes defining, I'm talking 100% cannot be absolutely defined until the word "process" is quantified and qualified. A small 50 person machine shop will have literally thousands of "processes" by the dictionary or ISO 9000..."3.4.1 process "set of interrelated or interacting activities that use inputs to deliver an intended result". A process can be like the "chicken or the egg" where does it start and where does it end? Well flitter, the ISO 9001:2015 standard and a QMS is in and of themselves "processes" requiring desired/needed inputs to arrive at the desired outputs. WILL SOMEONE PROVE ME WRONG PLEASE?

I could totaly stark raving crazy (which is easy for me) wanting to see evidence of every "process" monitored or measured let's say against, duhhhhhh "7.1.4 7.1.4 Environment for the operation of processes:" and my concern and desire would be the .... "b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective), piece because it's my "gut feeling" that NC product and late production times might be caused by this (and it can by the way). I, the whiz bang, all knowing auditor, want to know how 7.1.4 is being monitored and what are the KPI's? Now through interview I've found out that some "stress, concern, upset feelings, etc" are being created because the water fountain's water is not cold enough. Is this now a valid audit trail that could result in something negative because of lack of monitoring water temp and keeping a water temp KPI and it's causing an upset in 7.1.4? Is not the water part of the "7.1.4 Environment for the operation of processes"?

Now I know it's a stretch, but see how stupid it can get? That's why the organization should determine, monitor and measure those things that can effect the effectiveness of the QMS and meeting satisfaction and product requirements. This not to lay aside that if I, the all knowing, all powerfull, all capable 3rd party auditor see that there is a lack of effectiveness due to lack of monitoring something that I can't point it out and take appropriate action.

Excuse me so I can get some fresh shorts because these are probably going to have some holes chewed in them.
 

Golfman25

Trusted Information Resource
Sorta, and forgive me when I say "there has to be some common sense applied". Each and every "process" within an organization, within a MS truly escapes defining, I'm talking 100% cannot be absolutely defined until the word "process" is quantified and qualified. A small 50 person machine shop will have literally thousands of "processes" by the dictionary or ISO 9000..."3.4.1 process "set of interrelated or interacting activities that use inputs to deliver an intended result". A process can be like the "chicken or the egg" where does it start and where does it end? Well flitter, the ISO 9001:2015 standard and a QMS is in and of themselves "processes" requiring desired/needed inputs to arrive at the desired outputs. WILL SOMEONE PROVE ME WRONG PLEASE?

I could totaly stark raving crazy (which is easy for me) wanting to see evidence of every "process" monitored or measured let's say against, duhhhhhh "7.1.4 7.1.4 Environment for the operation of processes:" and my concern and desire would be the .... "b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective), piece because it's my "gut feeling" that NC product and late production times might be caused by this (and it can by the way). I, the whiz bang, all knowing auditor, want to know how 7.1.4 is being monitored and what are the KPI's? Now through interview I've found out that some "stress, concern, upset feelings, etc" are being created because the water fountain's water is not cold enough. Is this now a valid audit trail that could result in something negative because of lack of monitoring water temp and keeping a water temp KPI and it's causing an upset in 7.1.4? Is not the water part of the "7.1.4 Environment for the operation of processes"?

Now I know it's a stretch, but see how stupid it can get? That's why the organization should determine, monitor and measure those things that can effect the effectiveness of the QMS and meeting satisfaction and product requirements. This not to lay aside that if I, the all knowing, all powerfull, all capable 3rd party auditor see that there is a lack of effectiveness due to lack of monitoring something that I can't point it out and take appropriate action.

Excuse me so I can get some fresh shorts because these are probably going to have some holes chewed in them.
Actually I agree with you 100%. Problem is I have found common sense left the ISO world quite a while ago.
 

Sidney Vianna

Post Responsibly
Leader
Admin
Do we have to create a KPI for every process we have? For support processes, are we able to provide a log, for example, of what we perform within that process? What actually is required by Clause 4.4.1 c)?
This has been discussed a number of times. One of the authoritative documents that help in obliterating this myth that KPI's are mandatory is the ISO/TS 9002:2016. That document states the following:

Clause 4.4.1 c) vs. Clause 9.1.1
 

Big Jim

Admin
Forgive me for coming late to the party. Lots of great information already here, especially from Randy and Sidney.

I would like to add a few comments. First is that ISO has done a horrible job of defining what they mean by "process". Until they do there will continue to be confusion about what they are talking about in 4.4.1. In 8.5.1 f they talk about validation of processes where it is clear that they are talking about production processes, specifically "special processes", those that cannot be verified and need to be validated. Examples typically include welding, soldering, brazing, plating, and heat treating. It should be obvious that 4.4.1 is not about these processes.

As Sidney has explained in the past, the intended processes in 4.4.1 might be more properly referred to as your business processes. Some call them the core processes. For example: management, sales, purchasing, production planning, and production. As already mentioned, the organization gets to determine what their processes are. They get to determine how they are structured and what the activities are within each process. The auditor does not get that choice, no does the certification body.

I believe that 9.1, all of it, but especially 9.1.3 provides a healthy hint as to things you need to monitor and measure that can be selected as quality objectives and can do double duty as KPI if you choose to look at it that way. 9.1.3 a requires that you track conformity of products (product quality). 9.1.3 b requires that you track customer satisfaction. 9.1.3 c requires that you track the performance and effectiveness of the quality management system (often measured by on-time delivery or sometimes from all of the objectives / KPI collectively). 9.1.3 f requires tracking the performance of suppliers (most effective as a KPI for purchasing is collectively for all suppliers) (that doesn't take the place of tracing suppliers individually).

That's four topics that you need to be tracking anyway, so why not also use them for quality objectives / KPI? Don't let an auditor try to tell you that you can't.

Using the sample list of procedures from above as KPI might be as follows:

Management - customer satisfaction by itself or all four of them collectively - management is tracking them anyway
Sales - customer satisfaction & on-time delivery (if they set lead times)
Purchasing - supplier performance
Production Planning - product quality & on-time delivery
Production - product quality & on-time delivery

Yes, you can use any one indicator more than once and some processes may have more than one indicator even though some uninformed auditors believe you can't.

Read 4.4.1 carefully as others have already pointed out and don't let an uninformed auditor bully you.
 

Nadaabo

Involved In Discussions
So here's a fun situation we're working through:

We kept our processes simple : Sales, Design&Development, Materials, Production. Each has a small set of KPIs that we measure.

This year, we were told during our AS9100 audit (note, we've been AS9100 certified since 2008):
- If we don't meet the OTD for suppliers (8.4.1.1) over 2 audits, then we get 2 major CARs, one for not meeting the target and one for our CAR process not being effective because we're not able to fix the problem.

- one of our Production process KPIs is OTD of the products we build and one of our Design process KPIs it is the OTD of the design package to the customer. The auditor told us we can't use the same KPI twice. He said the standard states OTD for products and services and it's the same metric.

I tried to argue that I can't do anything abut the supplier OTD (especially the single source mandated by our customers) and he gave some suggestions of maybe updating the delivery target to a lower one, or removing the customer mandated suppliers form the KPI... but we need to monitor all these suppliers. I don't want to have the "audit" list and then the normal KPI list we manage by.
and as for the shared KPI, he was very insistent and although I tried to ask where exactly in the standard that's noted he said for me to go read the AS9104 standard.

I like what @Big Jim said. It makes sense. I just need to figure out how to argue these points properly during an audit.
 

Golfman25

Trusted Information Resource
So here's a fun situation we're working through:

We kept our processes simple : Sales, Design&Development, Materials, Production. Each has a small set of KPIs that we measure.

This year, we were told during our AS9100 audit (note, we've been AS9100 certified since 2008):
- If we don't meet the OTD for suppliers (8.4.1.1) over 2 audits, then we get 2 major CARs, one for not meeting the target and one for our CAR process not being effective because we're not able to fix the problem.

- one of our Production process KPIs is OTD of the products we build and one of our Design process KPIs it is the OTD of the design package to the customer. The auditor told us we can't use the same KPI twice. He said the standard states OTD for products and services and it's the same metric.

I tried to argue that I can't do anything abut the supplier OTD (especially the single source mandated by our customers) and he gave some suggestions of maybe updating the delivery target to a lower one, or removing the customer mandated suppliers form the KPI... but we need to monitor all these suppliers. I don't want to have the "audit" list and then the normal KPI list we manage by.
and as for the shared KPI, he was very insistent and although I tried to ask where exactly in the standard that's noted he said for me to go read the AS9104 standard.

I like what @Big Jim said. It makes sense. I just need to figure out how to argue these points properly during an audit.
Does this clown even realize what he is saying? While I'm not entirely familiar with AS, I find it absurd that the fix is to manipulate who's included in the KPI or revise the KPI lower. Sounds like the Government. :)
 

Big Jim

Admin
So here's a fun situation we're working through:

We kept our processes simple : Sales, Design&Development, Materials, Production. Each has a small set of KPIs that we measure.

This year, we were told during our AS9100 audit (note, we've been AS9100 certified since 2008):
- If we don't meet the OTD for suppliers (8.4.1.1) over 2 audits, then we get 2 major CARs, one for not meeting the target and one for our CAR process not being effective because we're not able to fix the problem.

- one of our Production process KPIs is OTD of the products we build and one of our Design process KPIs it is the OTD of the design package to the customer. The auditor told us we can't use the same KPI twice. He said the standard states OTD for products and services and it's the same metric.

I tried to argue that I can't do anything abut the supplier OTD (especially the single source mandated by our customers) and he gave some suggestions of maybe updating the delivery target to a lower one, or removing the customer mandated suppliers form the KPI... but we need to monitor all these suppliers. I don't want to have the "audit" list and then the normal KPI list we manage by.
and as for the shared KPI, he was very insistent and although I tried to ask where exactly in the standard that's noted he said for me to go read the AS9104 standard.

I like what @Big Jim said. It makes sense. I just need to figure out how to argue these points properly during an audit.

Ask him to show you the shall. Ask where in the standard it says that you cannot use the same indicator more than once. If he can't clearly explain his position, place a phone call to your certification body and ask for their help with this auditor that wants to make up his own rules.

On missing your goals (KPI), they are your goals, not his. You have complete control over your goals, including that you can reset them to be more realistic when conditions require it.

Oh, and make sure you tell the office to keep that idiot away from your place in the future. He seems to have been asleep during training.
 
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