When is a Work Instruction not necessary or required?

[Randy]

In Reply to Parent Post by ScottK

I don't think I ever said WI's are not documents. That would be awfully silly of me considering how many I do have in my system.

What I don't have is a work instruction for every single operation.

"If necesary" and "as applicable" are pretty key phrases here, don't you think?

I've got a process to make a part. The part has a controlled drawing, it's got an controlled inspection sheet with chartacteristics, it's got a controlled bill of tools. There is an overall departmental procedure that describes how these interact for all parts. This part is well within statistical control.
(edit: )Oh yes - I've also got qualified operators with documented training and credentials.

That's what COMPETENCE is about...seperate discussion
Lets not encourage people to overdocument.

I'm a minimalist myself

[ScottK]

In Reply to Parent Post by Randy

I'm a minimalist myself

not sure I follow the "competence" comment

[dQApprentice]

Hi ScottK,

no one is perfect in every way and it’s hard to become one but it’s pretty much hard to be humble. i admired your humility

[Logic]

Putting aside the requirements of ISO and other Standards, Work Instructions can be as simple or as complicated "as necessary". Depending on an individual's memory as the source of information can be very costly. Memory is affected by fatigue, excitement, pressure, time constraints etc. and that is when it tends to fail and the result can be costly,embarrassing or lead to questions about legality of actions. An example of this follows.

Thursday January 22 2009

President Barack Obama was sworn in yesterday for a second time by Chief Justice John Roberts, a cautionary do-over that occurred because they bungled the constitutional oath of office at the Jan. 20 inauguration.

Roberts went to the White House for the second swearing-in at 7:35 p.m. Washington time in the Map Room of the main residence.

At the inauguration ceremony witnessed by more than 1 million people on the National Mall and millions more worldwide, Roberts misstated the oath as “execute the office of president of the United States faithfully” and Obama followed suit.

The Constitution requires presidents to take the following oath: “I do solemnly swear (or affirm) that I will faithfully execute the office of president of the United States, and will to the best of my ability preserve, protect and defend the Constitution of the United States.”


If the very important WI had been followed .......

[Jim Wynne]

In Reply to Parent Post by dQApprentice

If Work Instruction is not a document, please tell us what is it?

He didn't say that a WI isn't a document; he said that "document" could mean something other than WI.

[dQApprentice]

In Reply to Parent Post by Jim Wynne

He didn't say that a WI isn't a document; he said that "document" could mean something other than WI.

In Reply to Parent Post by ScottK

The requirement is "documents", not work instructions.

Sorry if I misunderstood the statement.

[dQApprentice]

In Reply to Parent Post by Jim Wynne

He didn't say that a WI isn't a document; he said that "document" could mean something other than WI.

My intent when I raised the question is to clarify (nothing else) because there are too much information flying around that it’s hard to make sense of it all and LexieB might end up more confused than enlightened.

[Randy]

In Reply to Parent Post by LexieB

Hi all,

I'm new, so I should introduce myself really quick. I'm Lexie, and I'm coming from a few years of QA experience in medical device manufacturing and have now been recruited as Quality Director in the machine manufacturing industry. Part of my job at this new place is to obtain ISO certification, so of course the first thing I do is conduct my own mini-audit just to get a feel. If I were to be provided that evidence then the WI question would most likely die right there.

First issue: they have no work instructions for the major machines. At my previous place of employement, we had a work instruction for everything. When I brought up the idea of having WIs for the machines here, I got some eyebrow raises. They explained that 1) their customers are not asking for it, and 2) it's impossible because the machinists are hired on 10+ years of experience, and training is performed as an apprenticeship. According to the foreman, "I can tell whether they know the machines or not after watching them for 90 days." (Small family company, so I don't know if it makes a difference.)

Do you have any recommendations for handling this, and is a WI necessary for everything?

Thanks in advance!!

Looking at this in its entirity all we have is is an issue of competence....If, and I say "IF" this is the entire scenario I, a 3rd party auditor, would not be too concerned with a lack of WI's because there is some level of assurance of competence and effectiveness of the process involved....I would be concerned with required competencies and documentation of their achievement and records that could demonstrate that product conformity was being achieved as well.

WI's tell people how to perform tasks and that's where 4.2.1(d) comes in to play....If the organization determines that effective fulfillment of a task can only be achieved on a continual basis by documenting how to do it, then the instructions for doing so must be generated....using whatever format the organization determines to be appropriate, flowchart, process map, picture, or templated document, it doesn't matter....it's the organization that makes the decision on when and how.