Is it worth to document all the processes?

qualprod

Trusted Information Resource
#1
Hi everybody

I have some doubts if i have to take into considerations to document a process, which in my case is
not critical, is 7.1.3 Infraestructure, and additionally most of these serveces are provided by an external provider.

The requirements in 4.4.1

"The organization shall determine the processes needed for the quality management system and their
application throughout the organization, and shall:"

"c) determine and apply the criteria and methods (including monitoring, measurements and related
performance indicators) needed to ensure the effective operation and control of these processes;"

It is a small factory , 10 people, really the needs for infrastructure are
minimal, also I don´t see the need to set a kpi to measure its performance.

I know that I have to take into considerations the core processes, e.g. Purchasing, production, quality, delivery,
but in doubt if i have to include Infraestructure for what I explained.

I also know that the standard does not require to have it documented, altough I know i need to have evidences to prove I´m complaining with it.
For that I will have ready service reports of an external provider, who in most of cases helps me in that need,

What do you think about this?

Or is it valid to have it shown in the process map also in a procedure but not to set Kpis?

Please help.
 
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Tagin

Trusted Information Resource
#2
I think for 7.1.3 it suffices to have a table of the maintenance items, with columns something like: who is responsible to perform/manage them, and frequency of maintenance. That is what we have used, and have had zero NCs or auditor concerns.

Outsourced maintenance services, of course, also needs to be addressed per 8.4.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#3
Not sure the industry but for medical devices the infrastructure clause can tie into the requirement to prevent mixups. If an auditor were to tour the facility is it clear that there is low risk of mixing materials? Conforming vs non conforming? The evidence we use is pest controls, temp RH controls, cleanliness of product, segregation of product. We use physical barriers for inventory and raw materials and finished goods as well as a reject room. If you can show you work area comfortably and its not cramped that a huge benefit to answer that challenge


Because each product and process is unique its not easy for a reviewer to claim "Thats not enough room for that" but a cramped workplace with water on the floor and dirt everywhere makes that claim easier.
 

John C. Abnet

Teacher, sensei, kennari
Leader
Super Moderator
#4
Good day @qualprod ;
I believe you may have already answered your own questions by quoting the following...
""The organization shall determine the processes needed for the quality management system and their
application throughout the organization, and shall:"


Be selfish. Do what is beneficial to the organization. A process map (visualization of sequence, etc...) can be a very helpful tool...particularly when onboarding new associates. If that is a method you utilize, show what processes you wish to show, (if/as it benefits the organization) and then ...

"c) determine and apply the criteria and methods (including monitoring, measurements and related
performance indicators) needed "


It is up to the organization to "determine" and "...apply...as needed".
Remember, excluding what is needed does NOT benefit the organization so don't simply use these statement as a loophole to exclude what is "needed for the quality management system".


In regard to infrastructure, only your organization can determine the significance and any "...monitoring and measurement.." that may need applied. Regardless, don't overlook the fact that ISO 9001 does indeed speaks specifically to infrastructure (7.1.3) and the potentially related environment (7.1.4)

Summary:
Do for the ORGANIZATION (not the auditor) what is needed for management system effectiveness which should correlate (be "equal" to) the effectiveness of the organization.

Hope this helps.
Be well.
 

Pancho

wikineer
Super Moderator
#5
... the needs for infrastructure are minimal, also I don´t see the need to set a kpi to measure its performance.
I think you're answering your own question, at least while you're still starting with your QMS.

Just keep in mind that documenting a process is a valuable springboard for improvement. If you run across a non-conformity, or risk, related to "infrastructure", (and you will, eventually) think about whether it is one-off, or something that could recur. If you didn't before, document the process at that time as improvement action. As your system matures, it is likely you will find the process documentation getting more and more robust, and your quality better and better.
 

Randy

Super Moderator
#7
You're looking too deep and getting confused, read the requirement again..
The requirements in 4.4.1 "The organization shall determine the processes needed for the quality management system and their application throughout the organization"
It says "processes needed for the quality management system"...Not everything within your 4 walls (or however many you might have)
 

John Broomfield

Leader
Super Moderator
#8
Document your management system to the extent necessary for effective planning, operation and improvement.

Avoid over documenting your system cuz it may: insult the intelligence of the system’s participants, cost a fortune to keep up to date and make essential information difficult to find.

Remember that several processes within the management system tend to grow detail and hardly any reduce detail. So, you could periodically review system documentation to confirm its value to the organization.

Never document any part of your management system just to keep your auditor happy!
 
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