Clause 4.4.1 c) vs. Clause 9.1.1

Bluzman714

QMS Coordinator
Our organization (molded plastics manufacturer) has several Quality Objectives that are key process indicators to ensure the effectiveness of our QMS. Clause 9.1.1 leaves the determination and selection of KPIs to the organization. Clause 4.4.1 c) seems to contradict Clause 9.1.1. It seems to require the organization to determine and apply criteria and methods needed to ensure the effective operation of ALL processes. Not all of our processes are "key" processes. Some are "support" processes.

We're being pressured by a new auditor from our registrar to produce KPIs for all our processes per Clause 4.4.1 c). We've never had to do this in prior audits with this registrar. We provided a process interaction map and a list of our processes in the order in which they occur. Included in the process list were support processes (e.g., maintenance), but they were not specifically denoted as such. Our tooling department, for example, is only in place to support production for repairs and general maintenance of the molds.

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)?
 

Randy

Super Moderator
Tell your new auditor to stuff it. Nowhere is the word "ALL" used. The determination and application of monitoring and measuring is up to you to do, not some slack jawed, self inprotant, ego inflated auditor to demand.

Ask the auditor to define "process" and explain the limitations of the definition
 

Michael_M

Trusted Information Resource
Randy is correct and I will add the requirement of 4.4.1c states "Determine and apply the criteria and methods....". This very clearly says 'you determine what is to be needed to ensure the effective operation'.

Emphasis is mine.
 

Golfman25

Trusted Information Resource
Our organization (molded plastics manufacturer) has several Quality Objectives that are key process indicators to ensure the effectiveness of our QMS. Clause 9.1.1 leaves the determination and selection of KPIs to the organization. Clause 4.4.1 c) seems to contradict Clause 9.1.1. It seems to require the organization to determine and apply criteria and methods needed to ensure the effective operation of ALL processes. Not all of our processes are "key" processes. Some are "support" processes.

We're being pressured by a new auditor from our registrar to produce KPIs for all our processes per Clause 4.4.1 c). We've never had to do this in prior audits with this registrar. We provided a process interaction map and a list of our processes in the order in which they occur. Included in the process list were support processes (e.g., maintenance), but they were not specifically denoted as such. Our tooling department, for example, is only in place to support production for repairs and general maintenance of the molds.

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)?

Welcome to hell. Don't ask how I know. :) 4.4.1 C only requires ensuring the effective operation and control of the processes --related performance indicators is only one way to do this. Here's your work around -- find a KPI applicable to "multiple processes" and identify that. We use a financial measure -- a special gross profit calculation. We also use on-time delivery for a bunch of places cause everyone effects that. Good luck.
 

qualitymanagerTT

Involved In Discussions
Tell your new auditor to stuff it. Nowhere is the word "ALL" used. The determination and application of monitoring and measuring is up to you to do, not some slack jawed, self inprotant, ego inflated auditor to demand.

Where in clause 4.4.1c does it say "some"?
 

qualitymanagerTT

Involved In Discussions
Randy is correct and I will add the requirement of 4.4.1c states "Determine and apply the criteria and methods....". This very clearly says 'you determine what is to be needed to ensure the effective operation'.

Emphasis is mine.
I don't understand that text to mean "determine which processes" the organization selects for applying criteria and methods, based on you agreeing with the earlier comment about the absence of the word "all".

Is there a different document or recognized source which provides the interpretation you agreed with?
 

Golfman25

Trusted Information Resource
I don't understand that text to mean "determine which processes" the organization selects for applying criteria and methods, based on you agreeing with the earlier comment about the absence of the word "all".

Is there a different document or recognized source which provides the interpretation you agreed with?
You have to "determine" some sort of effectiveness measure for each process. The problem occurs with tangential processes to the organization. The OP mentions two -- maintenance and tooling. KPIs are good if you have enough data and the process runs on a regular basis. But something like maintenance may be a once a year thing -- i.e.; change the oil. You end up spend more time on a KPI than actually doing the maintenance so the value add isn't there. You could come up with a bunch of KPIs for the OPs tool room, but so what. What really matters is their ability to turn tools in order to meet delivery dates. So they are part of on-time delivery. In our case, we don't have specific metrics for either process. However, they do show up on our pareto chart identifying issues with cause problems with on-time delivery.

Auditors who want to see individual KPIs for every process are using the "laziest auditor standard." Makes it easy for them to look at the KPI, check the box, and move on.
 

Golfman25

Trusted Information Resource
Not this one, I really don't care about every process, just the ones "determined"
You seem to be taking a little bit of a leap which has me confused. For clarification are you saying the organization gets to determine the process, and thus if no process, then no measurement? Or are you saying, even though the organization determined a process, they don't have to determine a measurement for that process?
 
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