ISO 9001 - Requirement for Work Instructions

M

meow4easthills

Hello,

New to forum, some fantatic information available!

I have just completed an audit and issued three CARs to the auditee for not having work instructions, below is a bit of a background.

I work in a call centre and was conducting quality/compliance audit on the call centre operations, I listened to a number of calls and identified there was an issue with adherance to a particular process. I asked a number of Team Leaders if a work instruction exists for this process, they advised that there wasn't. I also noticed there no work instructions readily available for staff, the explanation given was that 'they just weren't needed as they can speak with the Team Leader if they get stuck', I asked what about if they need it and no Team Leaders are around or they need it urgently - I was told they can wait until a team leader becomes available (this would involve terminating the call and waiting). Finally, I asked about information guides which describe the product - I was advised this was not needed as it would confuse the agents

The two cars were:

1) No work instructions were available for any process - instructions should be able as required and not just rely on Team Leaders for instructions(ISO 7.5.1)
2) Work instruction needs to be specifically created for particular process, error identified with performing this process.
3) Product Guides should be available which describe product

I held a closing meeting and was told all these should just be opportunities for improvement - I thought this may be because of the way I worked it, I explained in detail why the CARs were being issued, however these were the rebuttals I received.

1) We don't need work instructions because it doesn't anywhere we need them - they said speaking with a team leader was sufficient if they get stuck.
2) Once again, don't need a work instruction for this process - I advised an issue was identified with this process so there should be a work instruction.
3) Product guides will create confusion, therefore not needed.

Can I please grab you're thoughts on these CARs, are they valid? do these warrant CARs being issued?

Look forward to your response.
 

Randy

Super Moderator
Refer back to 4.2.1 "d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes."

Now if you identifed that they have a problem, which you indicated, you can use this as being "ineffective" in its implementation. Just make sure you have good solid evidence
 
M

meow4easthills

Hello,

Thanks for that feedback!

So there is solid evidence that a lack of work instructions contributes to the process breakdown.

How about when the auditee has NO work instructions at all and there exuse is they can ask the team leader, there is no evidence (at this stage) that a lack of documentation affects the QMS, but it is concerning that NO work instructions exists? (basically, is "they can speak with a team leader" a sufficient excuse to be excluded from having work instruction under 7.5.1?)

Thanks.
 
C

Chris Ford

Hello,

New to forum, some fantatic information available!

I have just completed an audit and issued three CARs to the auditee for not having work instructions, below is a bit of a background. <snip>
I've provided audit training, established and managed audit programs, and have personally audited over 800 organizations during my career. I can say that we do get better in time and with much practice.

Based on the nature of your questions, I'm guessing that you're relatively new to auditing. The golden rule you'll want to forever live by as an auditor is your mission is to confirm conformance to a standard - NOT to seek out nonconformities. That said, try as we may, we will usually find a nonconformity or two... or three. And sometimes, we find ourselves struggling - if we find no nonconformities, it will seem that we were lazy and didn't do our jobs.

There may be an auditor who will chime in to this conversation, and validate everything you've said - or maybe disagree with everything you said. In either case, the auditor would be wrong to do so.

Based on the information you provide, it's impossible to determine whether there was any nonconformity, or the degree of a nonconformity.

They may be 100% correct - work instructions may not be necessary; product documentation may be too technical for the call center personnel and may confuse them.

Things to consider: how many people in the call center, how many products, how many people have the same problem with the same product? If there are 200 people in the call center during a shift, split into departments that handle various products, so you have maybe 10 people handling the same product, are all of them having the same problem? Was it one person? Two? One person having problems with multiple products or multiple people having problems with the same product?

Look for trends, before you state that a systemic problem exists. 7.5.1 only requires work instructions as necessary. If the auditee claims a work instruction is not necessary, you will need substantial evidence to show them they are wrong. But why? Just to say you're right and they're wrong? Unless you can provide evidence that the same problem exists across multiple people, multiple products, multiple shifts, etc., I honestly don't think you have much of an argument. If anything, this would be an opportunity for improvement - follow up on it next time.

The same holds true for product guides. You state they need to be available, citing 7.5.1, however the standard clearly states that controlled conditions shall include, "as applicable" the availability of information that describes the characteristics of the product.

Perhaps in the company's opinion, it isn't applicable, and maybe they have a great reason for that. But, if you're stuck in the idea of forcing them to provide product guides, when they clearly don't want to, I doubt you'll get very far in this situation.

Work instructions are one thing - they're a pain. I can see a lot of people cringe when I suggest work instructions. It means they have to write something, and get it reviewed and approved... go through all the red tape. But product guides? They're already written. Just get them from the document control department and hand them to people. It's so simple, you have to wonder why they don't do it... unless, it's like they said - they confuse the employees. Give the auditee some slack - they know what they're doing. They do it every day.

Walk in to an audit with the intent to learn something and the intent to confirm that they're compliant, and nine out of ten times you'll come out with a thorough and comprehensive audit report.

One last point of advice, leave opinion completely out of the equation. Write statements of fact. Use the standard almost verbatim - for example:

"The organization failed to carry out production and service provision under controlled conditions, in that information that describes the characteristics of the product was unavailable to any of the employees in the Elsmar department during the first shift. Further, four employees were observed terminating calls with customers, because no work instruction describing the escalation process is available."

Individually, these may be opportunities for improvement, but together they begin to paint a picture about how the organization has implemented its control of service provision.

Hope that helps!
 
M

meow4easthills

Hello,

Thanks for that response, it is very helpful.:thanx:
Yes I am relatively new, I have been doing audits for 2 years.

I think they problem is that even with evidence of a process failure/breakdown, the auditee does not beleive that work instructions will assist (and we keep coming back to 'it doesn't anywhere that we need a work instruction'). I think I may be :deadhorse:

I will be leaving this organisation shortly due to a number of internal issues, but I appreciate the response as it will assist me in the future!
 
C

Chris Ford

Good. I hope it does. You might be right. Oftentimes internal auditing is really the most difficult of audits. As an auditor, I hope you get the opportunity to experience external supplier audits. It really broadens your mind in many ways.

You're right, too. It is beating a dead horse, if you've pointed this out before. As long as they can demonstrate that what they are doing currently is effective, they just need to continually improve on that. So, it's an opportunity for improvement - you've pointed it out. They can't ignore it. So, at some point, maybe they'll achieve it and surprise you.

Good luck in your future endeavors!
 

somashekar

Leader
Admin
Hello,

Thanks for that feedback!

So there is solid evidence that a lack of work instructions contributes to the process breakdown.

How about when the auditee has NO work instructions at all and there exuse is they can ask the team leader, there is no evidence (at this stage) that a lack of documentation affects the QMS, but it is concerning that NO work instructions exists? (basically, is "they can speak with a team leader" a sufficient excuse to be excluded from having work instruction under 7.5.1?)

Thanks.
You are auditing, and as an out come of your audit, you are coming out with findings of procedure Vs practice not being effective with sufficient examples, or suitable procedures are not in place to address process requirements.
You are not the one to say about work instruction as an audit output. If the work instructions are deemed necessary by the auditee towards the audit finding., then as a corrective action a work instruction can be brought in by the auditee.
Procedures Vs practice can also be improved without bringing in a work instruction.
Your audit output is not a prescription that has to be followed.

Procedures are just consistent way of doing a thing by all concerned personnel.
Work instructions are documented procedures.
 
Last edited:
M

meow4easthills

Hello!

Thank you all for your feedback. The different perspectives are great!

So here's part of my issue, there is not much knowledge of the 9001 standard in our organisation, so when If I was to say 9001 Jargon (product realisation, quality policy, quality objectives, etc) I often get a blank look or the BS routine, so I try and break it down but often this will involve putting my own spin on it (as I am interpreting the standard for them).

I am sure you guys have faced this, how do you overcome it?

Thus part of the reason I am leaving, no one has much knowledge of the standard because many of the top execs in the company don't have much regard for the quality standard (and compliance for that matter) it is essentially a "door opener, but not much else" (to get new contracts - this is how it has been described to me by the execs) infact they wanna get rid of it but they can't.

I have tried selling the benefits, but there is to much disregard for it.
 

Colin

Quite Involved in Discussions
There used to be a statement in an older version of ISO 9001 that said something like '... provide work instructions where the absence of such could adversely affect quality ...'. I still use the logic now.

In other words, if not having them doesn't cause a problem, they don't have to have them. Having work instructions is usually a trade off between competence and documentation.
 

AndyN

Moved On
So here's part of my issue, there is not much knowledge of the 9001 standard in our organisation, so when If I was to say 9001 Jargon (product realisation, quality policy, quality objectives, etc) I often get a blank look or the BS routine, so I try and break it down but often this will involve putting my own spin on it (as I am interpreting the standard for them).

I am sure you guys have faced this, how do you overcome it?

You don't! Everyone knowing ISO isn't necessary, any more than you having to know building specs to live in a house! Someone does, of course - the QMS "Architect" and the Process Owners should know their requirements (like electrical code, plumbing code etc)
 
Last edited:
Top Bottom