When is a Work Instruction not necessary or required?

[ScottK]

In Reply to Parent Post by Randy

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.

yes.

[bluesky16]

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.

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!!

sorry if this question has been replied to already, but work instructions are needed when you have key process variables you're trying to manage. If the work step doesn't materially affect the process outcome, then no work instructions are necessary.

Think of it this way; if your process is to catch a specific bus to get to a specific destination, you'll want the work instructions to detail the time the bus arrives, and the bus number. You won't need a work instruction on removing the change from your purse or pocket, even though that is technically part of the process.

[Stijloor]

In Reply to Parent Post by bluesky16

sorry if this question has been replied to already, but work instructions are needed when you have key process variables you're trying to manage. If the work step doesn't materially affect the process outcome, then no work instructions are necessary.

Think of it this way; if your process is to catch a specific bus to get to a specific destination, you'll want the work instructions to detail the time the bus arrives, and the bus number. You won't need a work instruction on removing the change from your purse or pocket, even though that is technically part of the process.

The best tool to help you determine if a work instruction is necessary, is to perfom a risk analysis. A process FMEA comes to mind.

Stijloor.