Definition SOP's (Standard Operating Procedures) vs. Work Instructions - Differences?

[db]

Who says? Where is this written in the "thou shalts" of life or business?

It's all gibberish and gobbeltygoop,

Well, in part ISO 9000 states a procedure is: "specified way to carry out an activity or a process." (3.4.5) So, it is process-based.

A work instruction is typically focused on the way to carry out a task. Now, a task is an activity, so there is some blending. But if you want to make a distinction, there is where I make mine.

With that said. I agree to the gibberish (to an extent) working with medical device manufacturers and aerospace folks, they seem to call everything procedures. That is okay. I teach the 4-level documentation pyramid. But I say that your documentation will tend to fall into one of the categories, not that it has to. I also state not to get too wrapped up in the words. If you have a work instruction for document control that meets all of the 4.2.3 requirements, then don’t write a nonconformance because there isn’t a procedure (I stress the “activity” listed in 3.4.5.

The key is to make sure your documentation works for you, not you work for it.

 

[Kevin H]

At my current employer, a work instruction applies at department/process and lower while SOP's are the main stay of the quality system - level 2 documents. At my prior employer, we used neither term, instead using the term BSP=Butler Standard Practice, for both level 2 and level 3 type documents. You told which document was which by the number and sign-off assigned to it.

As most others have said, don't get hung up on terminology, use what works for you and your unique quality system.

 

[tomjess]

Well, in part ISO 9000 states a procedure is: "specified way to carry out an activity or a process." (3.4.5) So, it is process-based.

Sorry, but what is (3.4.5)?

 

[Douglas E. Purdy]

ISO 9000 QMS Fundamentals & Vocabulary

Sorry, but what is (3.4.5)?

Look back 2 responses, db indicates that 3.4.5 is from ISO 9000, the QMS Fundamentals & Vocabulary Standard. The 3.4.5 is the paragraph numbering where the information is found.

Doug

 

[AndyN]

In general terms..........

Can anyone tell me the difference between SOP's and Work Instuctions.

Thanking you in advance

SOP's were considered to be the descriptions of the procedures for management to get things done. For example, how a purchase order was created from a requisition, or a supplier evaluated/selected, how gauges are controlled for calibration and so forth. A work instruction would be used where some further detail is required to describe an activity which is related to the procedure. So, for the supplier evaluation, there might be a work instuction to step a supplier QE through the activities of conducting a supplier audit, for the gauge calibration there is usually a WI on how to perform a cal. on (for example) a micrometer.
I agree that in many cases the lines are blurred and too many times the question has been asked.... "is this a procedure or a work instruction?"
Personally, apart from the 6 procedures required by ISO 9001:2000 (or 7 for ISO/TS 16949) everything else should be a 'process'. The need for other types of documentation to control these processes becomes the issue and you can call them what you'd like to!

Andy

 

[ralphsulser]

SOP's I agree that in many cases the lines are blurred and too many times the question has been asked.... "is this a procedure or a work instruction?"
Andy

We differentiate by the title and document control number on the document:
Such as:
Work Instruction QC-WI-017
Standard procedure QC-SP-003
Plus the hard copies are placed in separate, labeled 3 ring notebooks, and separate file folders on the computer files.

 

[Caster]

Way out in left field

Can anyone tell me the difference between SOP's and Work Instuctions. Thanking you in advance

There is another thread on white collar vs blue collar and problems with communication and respect.

I submit for your consideration:

Policies and procedures are documents which outline broad requirements and provide general guidance. This is all we need provide to white collar thinkers.

Blue collar factory grunts need work instructions to tell em just exactly what to do and how to do it.

This subtle slam has begun to bother me. Another artificial separation.

Our system has

QA manual
Policies
Procdures
Processes
Maps
Turtles
Work Instructions
Forms
Charts
other things I forgot

I wrote it, and now I'm not sure I could explain what separates a Policy, Procedure or Process....or why our WIs say things like "turn the ON switch to ON"...I kid you not.

I will not even begin to try to describe our document numbering system....(and yes I know there is no requirement for doc numbers...it's just so hard to kill them now that there are thousands of them)

If I could start again, I may go with just maps, flowcharts and forms. And lots of pictures with call outs.

Kind of funny, since the first manual I ever wrote back in about 1984 was just flowcharts and forms....but, I didn't know anything then, I just did what made sense to me.

I think I'd used words like "best practice", or "technique", or even "method" to avoid the blue/white work/think stereotype

I am beginning to think that the documentation pryamid needs to be re thought...too much effort expended for very little value...

 

[Hisar - 2009]

SOP's Vs WI

Just for sharing.

It depends on how we design the QMS. In our company, I had set up quality manangement system for QS-9000 and ISO/TS 16949 as below:


Level 1 :
Manual

Level 2 :
Procedure : Who, What, When?

Level 3:
WI & SOP : How?

I define as below :
SOP : Work Instruction related with process parameter and product
type, issued during new product development phase
(APQP). This should be comply with QS-9000 requirements as
stated in 4.9.1.

WI : Detailed instructions as a breakdown of the activity
stated in the Procedure.


Regards,
Hisar Simanjuntak
QA Manager
PAKO GROUP - Automotive Wheel Rims Manufacturer
Telp. 62-21-6511228
Mob. 62-8121970067
Email. Hisar@pakoakuina.com
web. www.pakoakuina.com

 

[canyon2010]

Does a work instruction have to have a DCN and also a rev history page? We just implemented an automated document control software, and I will post some documents that outline how to use the software (instructions), and also what folders the docs are stored in and what route you shoudl route the docs on. The software can note the changes on the document. I just wonder if I need the extra fluff pages on the front of each of these types of documents. What do you think?

 

[db]

Does a work instruction have to have a DCN and also a rev history page? We just implemented an automated document control software, and I will post some documents that outline how to use the software (instructions), and also what folders the docs are stored in and what route you shoudl route the docs on. The software can note the changes on the document. I just wonder if I need the extra fluff pages on the front of each of these types of documents. What do you think?

Why would you need any of that? Part of the answer may be where your requirement for a DCN and rev history page comes from. ISO 9001, for example, requires none of that. Figure out what is actually required and what makes sense for your company.