Processes vs. Procedures

I'm hoping you wise ones will be able to explain this to me as I'm getting tied up in knots over this and google is just making it worse!

We have processes which are flow diagrams to show the steps taken in for example, building a product, from IQC through to shipment. Each process will have a number of process steps, for example 1. Order placed, 2. Components purchased etc.

Would the procedure be how each of these process steps are carried out? For example, 1. Order placed - open database, click new, etc and does each process step therefore need a procedure?

Do processes and procedures have to be audited internally or just procedures?

Any clarification or help would be gratefully received!

 

Good day Kerri;
Bear in mind that ISO 9001 is not prescriptive in regard to HOW you accomplish activities. Don't over think this or get caught up in what are sometime simply semantics.

Processes are "what you do". They have three primary components...
Input--> Conversion (action) --> Output.

Think of the process of baking a pizza.

The input is the raw pizza
The conversion is the heating/transformation to a baked pizza. (process controls are time and temperature and cooking surface , etc...
The output is the baked pizza.

"Procedures" (keep in mind ISO 9001 does NOT require any ...although they can be extremely helpful), may define WHO, WHAT, HOW, WHEN, WHY (these can "procedures", "work instructions", etc...etc...)\
Procedures, work instructions (whatever your organization NEEDS and whatever you call them), can indeed be in the form of a flow diagram.

The ISO 9001 standard is process based, so yes, the standard intends to get organizations to think in terms of the processes an organization performs, and then internal audits are to verify that these processes are performing as intended, while meeting the requirements of the ISO 9001 standard.

Hope this helps.

Be well

 

Kerri
No, you don't(!) - as John says, that is one way to define and communicate how to follow a process, but the process exists whether or not you have defined it. It is actions, "how work gets done".

PS I wouldn't get hung up on the "input - process - output" model either, unless you are thinking of production line type processes. Lots of other types of process are far more flexible and rely more on people making decisions based on the circumstances that face them and their competence. Think more of "trigger" / "objective" / "resources required" / "factors that may influence performance" / "outputs" / "other outcomes".

 

A process is not a document. Flowcharts, flow diagrams, work instructions, including a documented procedure. are documented information that support the operation of a process.

As per the definition of ISO 9000:2015, a procedure is "specified way to carry out an activity or a process. So, the answer would be Yes.

An audit, whether internal or external, should look into the performance (measurable results) and effectiveness (extent to which planned results are achieved and planned activities are realized) of a process. To produce the desired results, a process will need a lot of "things". The standard, somehow, has provided the list of those "things" in clause 4.4. This clause of the standard is supported by other clauses. For example: 4.4.1d is supported by 7.1, 4.4.1f is supported by 6.1, etc. Procedures, although no longer a mandatory requirement, support the clause 4.4.2a.

So, to properly and adequately audit a process, those "things" that support a process (which include procedures) should be checked.

 

Thanks all. Sorry, I missed a couple of words out of my original sentence which completely changed the meaning! I realise that a process is not a document...what I should have said was 'we have processes which are documented as flow diagrams.