Definition Process Definition - ISO 9001:2008: Arguments about what a "process" is

E

ERO0316

#1
Does anyone have a formal definition of what a "process" is in relation to ISO 9001:2008. There's a bit of a debate going on here and I value your opinions. Thanks!!!

:agree1:
 
Elsmar Forum Sponsor

John Broomfield

Staff member
Super Moderator
#3
Does anyone have a formal definition of what a "process" is in relation to ISO 9001:2008. There's a bit of a debate going on here and I value your opinions. Thanks!!!

:agree1:
ERO0316,

The official definition tells us that processes are bigger than activities. If, when determining the processes necessary for your system to succeed, you fly too high you may link everything the organization does into one process:

Creating customers who create customers.

This may be a mission for the system of interacting processes but it is not deep enough to analyze the system in order to determine ithe processes that are essential to fulfill its mission.

So, we fly a little lower and we see the organization's processes for getting work, doing work and getting paid. These three processes convert the needs of customers into cash in the bank. But normally, organizations fly just a little lower to see the processes with traditional names like: marketing, designing, selling, purchasing, manufacturing, shipping and invoicing. They comprise the core process. Everything else the organization does should improve the rate at which the core process adds value.

That brings us to the support processes. These are the processes that direct and sustain the core process. Many of them are mentioned by the standard such as controlling documented information, purchasing (note how this process may be part of the core process or not), training, managing continual improvement and auditing. But you may have to dig deeper for other essential support processes such as recruiting.

Fly too low and you will crash and burn in the weeds (aka, activities).

You know you are flying at the right height when you see the processes involving several departments or functions interacting and working (adding value, enabling value and preventing loss) to fulfill a shared process objective.

Processes may exist that neither add value or prevent loss. They are not needed for the system to be successful. You can safely ignore these processes. This is confused by some text books that tend to say a process must be doing good. It is the job of procedures (documented and undocumented) to determine the value of a process.

The process is the work and the procedure is the specified way of carrying out the work.

Enjoy your discussion and let us know what you agree or even if you agree.

John
 
Last edited:
E

ERO0316

#4
Thank you for that. I "knew" what you stated but couldn't put in a cohesive statement. We are a job shop, ISO certified, and the department that makes out tooling (that we produce customer parts with) claims they should be exempted from the rigors of ISO. They have never been audited, and are out of control. I have only been with the organization for a few months and am finding myself in he unenviable position of having to teach basic Quality System Management theories to pretty much everyone within the organization.

I have spent the last 22 years in a TS 16949 environment, so I take terms like "process discipline", "process linkages", "inputs & outputs" for granted. (You should have seen the blank stares I got when I talked about "internal customers"). This is a great organization with wonderful people but they are dogmatic about "what we've always done".

What you explained will help me get some of these folks to understand that EVERYTHING we do that touches a customers part has to be considered a process for the sake of ISO.

Thanks, again!
 
#5
Never been audited? Out of control? In that case, fire your CB! Seriously - if an auditor doesn't see the effects of a function which performs badly (if this is not simply your "take" on them) and doesn't make an issue of it, what are you paying them for? Also, what has the internal audit programme being focused on? Double whammy for the CB auditor!
 
W

Wilderness Woody

#6
What you explained will help me get some of these folks to understand that EVERYTHING we do that touches a customers part has to be considered a process for the sake of ISO.

Thanks, again!
This would be the correct viewpoint... even if your "activity" is as simple as to add a screw or a piece of adhesive to something, there is still a process to make that happen correctly!

A process can be broken down to smaller components (positions and moves) at which point the term "process" may be a little absurd, but those building blocks can form the specific process components and those can interact to build larger process systems.
:2cents:
 

John Broomfield

Staff member
Super Moderator
#7
Thank you for that. I "knew" what you stated but couldn't put in a cohesive statement. We are a job shop, ISO certified, and the department that makes out tooling (that we produce customer parts with) claims they should be exempted from the rigors of ISO. They have never been audited, and are out of control. I have only been with the organization for a few months and am finding myself in he unenviable position of having to teach basic Quality System Management theories to pretty much everyone within the organization.

I have spent the last 22 years in a TS 16949 environment, so I take terms like "process discipline", "process linkages", "inputs & outputs" for granted. (You should have seen the blank stares I got when I talked about "internal customers"). This is a great organization with wonderful people but they are dogmatic about "what we've always done".

What you explained will help me get some of these folks to understand that EVERYTHING we do that touches a customers part has to be considered a process for the sake of ISO.

Thanks, again!
ERO0316,

Nobody likes to be told what to do and especially by ISO!

Your colleagues may well be frustrated by their incapable processes. It sounds like they've not been provided with a management system that helps them to determine the requirements and to meet the requirements.

Even though it is top management's job to provide an effective management system, it is absolutely essential to engage your colleagues in the development of their system so they think about what they should do and have a sense of ownership.

I would keep quiet about ISO and focus everyone on developing their organizational process-based management system (named for your company) so it can be used and improved to satisfy customers and bring success to employees. Avoid calling it an ISO System!

Please let us know how it goes.

John
 

Helmut Jilling

Auditor / Consultant
#8
Thank you for that. I "knew" what you stated but couldn't put in a cohesive statement. We are a job shop, ISO certified, and the department that makes out tooling (that we produce customer parts with) claims they should be exempted from the rigors of ISO. They have never been audited, and are out of control. I have only been with the organization for a few months and am finding myself in he unenviable position of having to teach basic Quality System Management theories to pretty much everyone within the organization.

I have spent the last 22 years in a TS 16949 environment, so I take terms like "process discipline", "process linkages", "inputs & outputs" for granted. (You should have seen the blank stares I got when I talked about "internal customers"). This is a great organization with wonderful people but they are dogmatic about "what we've always done".

What you explained will help me get some of these folks to understand that EVERYTHING we do that touches a customers part has to be considered a process for the sake of ISO.

Thanks, again!
"Tooling should be exempt" is one of the craziest notions I have ever heard...they lock in every parameter that Production will have to fight with for as long as the part runs. They are the MOST important process, along with Engineering....exempt? That would be just "stupid," if I may be so direct!

They make substandard tooling, then Production, Quality, and Eng. has to fight with it for the next 10 years....sheesh....

Besides, if they are "good" as they probably think they are, they should be able to meet the simple ISO requirements for tooling hands down....what are the "scared of?" Maybe approach it from that angle and question their macho....:notme:
 
E

ERO0316

#9
Gents,
Thanks for the input. As I said, I come from a long time in a TS environment where certain things were "cultural". I have spent this Sunday afternoon writing my reports, which I will present to Management. However, first thing tomorrow morning I'm going to "suddenly" have a couple of wonderful "continual improvement" ideas centered around defining processes.... :)

John, you hit it right on the head, I think. Our "QMS has been window dressing only for a very long time. I was actually hired to foster increased systemic discipline. The audit process was (in my opinion) the quickest way to locate deficiencies. I have also performed a pretty comprehensive gap audit. This is a great company. The dogma surrounding "systems" stems from a complete lack of understanding that, especially in ISO, we have COMPLETE control of the conditions and standards that we apply to ourselves.

Helmut, I truly appreciate your input. Sometimes when you are neck deep in something you have a hard time seeing the obvious! Your comments allowed me to reset my thinking. I have just applied an operating procedure that should, within the next 90 days, or so, apply the "rule of 10's" to our tool making, and begin to focus on providing the operators the best chance of success.

Another "cultural" issue: Deficiencies within systems have always been personal at this company. I will work my tail off at emphasizing that "the system" was broken, not the operator.

If you guys don't mind, I'll probably pick your collective brains some more. I'm sure I'll encounter more that I get (even momentarily) confused by!

Helmut, Danke f?r die Informationen. Ihre Hilfe ist sehr willkommen! Ich w?nsche Ihnen noch einen sch?nen Tag.

I hope that's right. I was raised with Ostfriesen Deutsch and sometimes I get "dialectical"

Thanks, again, fellas! Erich
 
E

ERO0316

#10
Willie,
I didn't mean to "snub" you in my long reply! Sorry. Your comment was a great catalyst for thought! Thanks!!!!!!!! Erich
 
Thread starter Similar threads Forum Replies Date
L Audit Definition in ISO 9000:2000 includes "documented process"? General Auditing Discussions 2
M Are Risks and Opportunities Required as Part of the Process Definition ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
L Process Definition and Process Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
H Definition of a Critical Process EU Medical Device Regulations 9
D Definition Sub?Process in the Service Industry - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
M Definition Process Nonconformity - Definition and examples - AS1900 clause 8.2.3 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
J Definition Control - Definition of Control in SPC (Statistical Process Control) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 8
P IPC - In-Process Control - Definition Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
S Complaint Process flow: Need a generic definition which would flag an "MDR" Customer Complaints 7
R Definition Business Process Excellence - Definition (What is it?) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
M Process Classification - Definition for "operating process"? Process Maps, Process Mapping and Turtle Diagrams 3
K What is the definition of "In-process"? Quality Tools, Improvement and Analysis 4
Manix Definition Special Process Scope - CQI-11 & CQI-12 - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 10
S Special Process definition - Clause 7.4.1 part d AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L Is there a definition for Process Change? FMEA and Control Plans 14
P Definition Annealing Process definition and Its Contribution Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 8
Marc Definition Statistical Process Control (aka SPC) - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
Marc Definition Observed performance - Definition - Process Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
Marc Definition Expected "overall" performance - Definition - Process Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
D Definition Special Processes - Can anyone give me a definition of what a Special Process is? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 50
M Seeking: Good process definition (map or whatever) for an installation business ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A System Audits vs. Process Audits - A clear definition of the differences between each Process Audits and Layered Process Audits 2
M Definition Key Process Equipment (KPE) - Some criteria and / or a good definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
Marc Definition Process Audit - Internal and External - ISO9000 - A Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
D Definition Internal Customer vs. Process Partner - Definition of Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
J Need Help with FPY Data in Assembly Process Manufacturing and Related Processes 7
A When someone refuses to follow a process.... Misc. Quality Assurance and Business Systems Related Topics 21
E Software maintenance Process Software maintenance Process to IEC 6204? IEC 62304 - Medical Device Software Life Cycle Processes 3
R AS5553 Clause 3.1.7 f - "Implement a returns process....." AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
normhowe "The Problem with Quality Management: Process orientation, controllability and zero-defect processes as modern myths" Book, Video, Blog and Web Site Reviews and Recommendations 2
Judy Abbott General temperature used in the blasting process and laser process Manufacturing and Related Processes 2
B SOP for CNC turret punching machine for sheet metal process Manufacturing and Related Processes 0
A API Monogram audit review process Oil and Gas Industry Standards and Regulations 4
R AS9102 FAI Change in Material / Process Supplier AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
A Process mapping Process Maps, Process Mapping and Turtle Diagrams 1
R MDEL Process Canada Medical Device Regulations 4
optomist1 Rates Daily or Hourly Process Improvement Training Consultants and Consulting 2
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
B Toyota PPAP Process - Three Questions APQP and PPAP 3
R Changes vs CMO - How can we simplify this process? Supplier Quality Assurance and other Supplier Issues 3
A Ethics Committee Review Process for IVD Products EU Medical Device Regulations 2
V Laser Welding Process - Impact on Electrical Properties Reliability Analysis - Predictions, Testing and Standards 4
Q Process: Knowledge Section 7.1.6 of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
L Documented Information in Internal Audits Process (9.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A Sampling plan for in-process QC (medical devices) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
R MRB (Material Review Board) Process using MS Sharepoint or MS Teams Manufacturing and Related Processes 2
M Clinical Benefit of device that only aids in a process for managing or treating disease EU Medical Device Regulations 2
C In-process inspection - Tooling and assembly lines for automotive companies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M Efficacy of an IT process after a cyber attack ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2

Similar threads

Top Bottom