Where is the Requirement that says employees have to follow work instructions?

[vanputten]

Hello All:

I need some help. Where is the requirement that says employees have to follow work instructions? We have to have them. People have to be aware and competent. But where is the requirement that states employees have to follow the instructions? I have to write a non-conformance becasue an employee knowingly did not follow a very important instruction that ensures product integrity. What TS clause do I write this N/C against?

If you need more details to answer my question, please ask.


Thank you, Dirk van Putten

[qualitytrec]

I am leaning toward 5.5.1 or 6.1 or 6.2.2c or 6.4 . It depends on the circumstances IMO.
How long has it been going on and who if anyone knew about it before you decided to do the write up? Depending on your answer I could likely knock a few off of the above list.
Mark

[vanputten]

Thank you.

5.5.1 - Top Managment shall ensure that responsibilities are defined and communicated. It does not say we have to follow what is defined and communicated.

6.1 - The organizaiton shall determine and provide the necessary resources. The instruction and resources were provided. It has been a critical policy for 21 years. Everyone is trained and tested on the requirement. The requriement that was violated is part of our culture besides the training and testing. The resources were determined and provided.

6.2.2 c) - The organization shall evaluate the effectiveness of the actions (training / awareness) taken. This may apply but the employee new the requirement and even stated that they new the requirement when confronted during an internal audit. This may apply but is not really what I am looking for.

6.4 This may be the answer. The mystery requirment I am refering to is a requirement that no make up or skin cream is allowed at anytime in wafer fabrication area. The presence of the make up may have been an environemntal issue that could have effected product quality.

Independent of my specific issue, I found it VERY interesting that I could not find a specific, clear statement that says employees must follow planned arrangements. Hmmmmm.

Regard, Dirk van Putten

[Wes Bucey]

I may be sticking my foot in the road apples here, but it seems to me the training was not effective, because the employee did not really understand the ramifications of not following the work instruction - contamination, causing defective material, possible life, health, safety issues, etc. I'm sure you all remember some brownnose in school who could parrot back all the textbook responses, but didn't know how to apply the information to real life situations.

I don't know that I would write this as a major, since it is one employee, not systemic. It is certainly an opportunity for improvement in the evaluation process of employee training. Is there a separate policy for willful disobedience? In an extreme case, with defense materials, for example, such activity by an employee is akin to sabotage.

Remind me some day to revisit the tale of ceramic heat shields coming off space shuttles because employees (ignoring specific work instructions) at a supplier cleaned the tiles with a Scotch pad containing silicon which prevented the adhesives from working properly.

[qualitytrec]

In Reply to Parent Post by vanputten

Thank you.

Your welcome I think The reason i asked the question I did above is because it helps to understand who is at "fault".

In Reply to Parent Post by vanputten

5.5.1 - Top Managment shall ensure that responsibilities are defined and communicated. It does not say we have to follow what is defined and communicated.

It does not say that you have to follow it I suppose, though I believe it is strongly hinted at. If management says this is your job...then I would think that they expect you to do it. That is why management is supposed to define and communicate responsibilities. Beside some one elses responsibility is probably to make sure that the employees on that line are following the rules and regulations outlined and if necessary disciplining them.

In Reply to Parent Post by vanputten

6.1 - The organizaiton shall determine and provide the necessary resources. The instruction and resources were provided. It has been a critical policy for 21 years. Everyone is trained and tested on the requirement. The requriement that was violated is part of our culture besides the training and testing. The resources were determined and provided.

I believe a necessary "human" resource to be one who will act according to their responsibility and authority.

In Reply to Parent Post by vanputten

6.2.2 c) - The organization shall evaluate the effectiveness of the actions (training / awareness) taken. This may apply but the employee new the requirement and even stated that they new the requirement when confronted during an internal audit. This may apply but is not really what I am looking for.

If the training was effective I believe the employee would know how serious of an offeence it was. And if they do not care you replace them with someone who does. Despite what some here have said OE is real and when it is deliberate it is a broken part in a system that needs to be fixed.

In Reply to Parent Post by vanputten

6.4 This may be the answer. The mystery requirment I am refering to is a requirement that no make up or skin cream is allowed at anytime in wafer fabrication area. The presence of the make up may have been an environemntal issue that could have effected product quality.

Independent of my specific issue, I found it VERY interesting that I could not find a specific, clear statement that says employees must follow planned arrangements. Hmmmmm.

Regard, Dirk van Putten

Dirk, I believe that Management responsibility is what covers it. The management have to be willing to enforce (implement effectively) the system. If not iss just words and of course the employees are going to wear make-up or eat cream-puffs or test cologne while they are making waffers. And why not it is a free country, right. What are you a commie? Yes you have a system problem. and the problem is an undisciplined employee. or she did not understand why wearing make-up was not allowed. but there is a problem that can or does effect quality.
JMO&I,
Mark

[Greg B]

Dirk,

We tell all of our operators thsat they must follow the necessary Work Instructions during their induction. They then have a training matrix that ensure that they have been trained in the use of the WI and understand its content.

[Icy Mountain]

The standards do not say that employees must follow work instructions. That's the management responsibility stuff in Section 6. Requirements must be communicated and understood.

We communicate these requirements during training. Here is our Procedures Manual. You must follow the Procedures Manual. Here is the Internal Auditor. He is checking to see if you follow the Procedures. You were trained on the Procedures. Why do you not follow the Procedures? Do you not understand the Procedures? Do you need more training? Are the Procedures incorrect? Continual Improvement follows: clarifying, training, improving.

This may sound like a lot of Command and Control but I prefer this to "Well, I TOLD you that was how we do it!" I have no way to tell IF I told you, without a training record. I have no way to tell you exactly WHAT I told you, without a Procedure. I have no way to IMPROVE an undocumented, unstable (small p) process.

Deming was right. (Fresh coat of snow for the I-C-M-T!)

[Jonell]

Good morning,

I see one specific reference to work instructions. In fact it carries that title......."7.5.1.2 Work Instructions - The organization shall prepare documented work instructions for all employees having responsibilities for the operation of processes that impact product quality. These instructions shall be accessible for use at the work station."

It doesn't specifically state that the employee must use the work instructions, but perhaps it's only logical that if you are going to go to the trouble of creating them and placing them at the work stations, then you, as a company, would require the employees to use them?

Jonell