How do you decide what is a Process, a Procedure or Work Instruction?

[ISO 9001 Guy]

How do you decide what is a process, procedure or work instruction? I am in charge of moving my company from QS 9000 to TS 16949 and I am having trouble knowing where to start, as far as the Manual (can that be just a restatement of the standard with my organization's name in it), Procedures (I know there are 7 required), Processes and Work Instructions. I am feeling the pressure and would appreciate all the help I can get. Also, can I use most of our QS procedures since I feel they still apply.

Thanks,
P

A QMS is composed of processes--processes needed for the management system. Each QMS process is composed of activities, each of which could be cast as a process in its own right, but in the context of talking about a management process (using ISO parlance), these are regarded as activities within a larger process that is the management process. For example, a Corrective Action PROCESS is composed of several activities: identification of a problem/initiation of CA; root cause analysis; action implementation; verification of action effectiveness. A procedure describes the CA process, describing how it works, describing the sequence and interaction of these activities. A work instruction might describe how to perform any given activity, e.g., "Root Cause Analysis" flowchart or something.
Similarly, a Production process might be composed of the following activities: material cut; CNC mill; CNC lathe; CNC mill (again); Secondary ops (drill) . . . A Production procedure describes how these activities are organized with regard to sequence, perhaps with reference to a Traveler or Router. The Traveler could be considered to be a work instruction (or even a quality plan). A document describing how to set up a machine to run an order is also a work instruction.
So, a work instruction (activity/task-related) is to a procedure (process-related) as a procedure is to the quality manual (system-related). Where a work instruction typically states how to perform particular activities or tasks (step by step), a procedure organizes the sequence and interaction of the activities composing the process (or describes how they are organized). A system, composed of processes, is addressed by the quality manual, which includes some description of the sequence and interaction of the processes. At least that's my take on it.

 

[Proud Liberal]

1. Everything's a PROCESS. It's usually just a matter of how anal you want to get about your systems. Focus on processes that can affect your customer in any way.
2. A PROCEDURE details processes that cross departmental lines (requires approval from more than one manager / supervisor)
3. A WORK INSTRUCTION details processes within a department (only requires approval from one manager / supervisor)

 

[Bill Goss]

I am not sure I agree with #2 ... that is, a procedure must cross departmental lines. I mean, think about a procedure that is devoted solely to customer communication. Most companies have just one department that are allowed to communicate to the customer, whether it be Customer Service or Quality. The fact is, some processes and therefore procedures are directed to just one department.

 

[AndyN]

I'm not entirely certain that all the requirements of the standard are a process, either. I've never been a fan of some of the requirements which are procedures being a process! For the life of me I can't see why document control is a process, internal audits nor records control! To me, that leads to questions being asked about measurement and monitoring and you know where that rapidly leads! Are we really saying that document, audit and records procedures should be monitored and measured? I sincerely hope not...

 

[JaneB]

1. Everything's a PROCESS. It's usually just a matter of how anal you want to get about your systems. Focus on processes that can affect your customer in any way.
2. A PROCEDURE details processes that cross departmental lines (requires approval from more than one manager / supervisor)
3. A WORK INSTRUCTION details processes within a department (only requires approval from one manager / supervisor)

There are people who would equally firmly argue the exact opposite. For example, I seem to recall that Information Mapping is equally categoric in insisting that a process crosses departmental lines and a procedure does not, for example. And any kind of search of threads in this forum will throw up heaps of vociferous arguments about which is which or which should be. As for 'everything's a process'? Nah.

I think each organisation needs to come up with their own working definitions, meaning things that work for them. Frankly, I don't care if someone calls something a process or a procedure (or even that horrendously 4-syllable long WI thing, to which manufacturing systems seem quite wedded) as long as it works! I'd rather focus on the content, the clarity, and the usefulness of the documents, not spend countless hours trying to 'educate' people into which is which for very little or nil gain. The world's moved on.

Perhaps these rigid labels and categories were much more important once, but in the online environment (for example) if the intranet/extranet is well structured, then documents can be found and used. Which is the point of having them surely?

 

[Helmut Jilling]

I'm not entirely certain that all the requirements of the standard are a process, either. I've never been a fan of some of the requirements which are procedures being a process! For the life of me I can't see why document control is a process, internal audits nor records control! To me, that leads to questions being asked about measurement and monitoring and you know where that rapidly leads! Are we really saying that document, audit and records procedures should be monitored and measured? I sincerely hope not...

Sure...why not. Just keep it simple. A simple monitoring to see if these activities/processes are effective in providing what the company expects them to provide. One example, since you frequently stress that audits are often ineffective, would be to monitor the internal audit activities/process, to see if the company gets any value or benefit. Many of my clients monitor number of findings, including OFIs, to see if the auditors are doing a good job of finding improvements.

 

[Helmut Jilling]

1. Everything's a PROCESS. It's usually just a matter of how anal you want to get about your systems. Focus on processes that can affect your customer in any way.
2. A PROCEDURE details processes that cross departmental lines (requires approval from more than one manager / supervisor)
3. A WORK INSTRUCTION details processes within a department (only requires approval from one manager / supervisor)

Well, we could begin with something closer to an ISO definition of a process - an activity that takes an input and adds value, and produces an output (my paraphrase of ISO). A procedure just describes or defines that process.

 

[Helmut Jilling]

WELL SAID.
You've converted me.

...now, if we could work on your apparent political leanings...

 

[AndyN]

Sure...why not. Just keep it simple. A simple monitoring to see if these activities/processes are effective in providing what the company expects them to provide. One example, since you frequently stress that audits are often ineffective, would be to monitor the internal audit activities/process, to see if the company gets any value or benefit. Many of my clients monitor number of findings, including OFIs, to see if the auditors are doing a good job of finding improvements.

Helmut, I can't 'see' any 'number' that tells us whether these procedures are 'working'! The number of findings from an audit is open to too much variability to be an indicator of the procedure! The same for document control, records control and the others! They are ALL subject to variances which make any numerical value applied to monitor/measure them almost a waste of time.

Should a corrective action take 30 days? Should there be less than 10 instances of non-conforming product? Should it take less than 8 hours to review and approve a document?

I'd like to see the look on senior management's face when someone tells them that 'ISO says' they have to put resources behind gathering data on these procedures - which are far removed (in most cases) from the revenue/value adding processes of the business!

 

[nickyquality]

Hi there,

I agree confusion, confusion, confusion.