Short Case Studies - Major/Minor Nonconformance, Observation or OK?

E

eekostas

#1
Hello again,

i have some short case studies which i found over the net and i would like your help to clarify if they are cases of non conformarce or NOT. As i wrote in my third (only) post, i believe that through examples can learn a lot. I would appreciate any help.

1. During inspection of a warehouse of a firm, we have checked the returnable material / raw material file to the suppliers. It had been identified that a specific supplier is delivering a large number of non-compliant and damaged materials. Asking the Manager of the warehouse to inform us of the actions he took in order to address the situation, he said "I just send them back and wait for a replacement, with the next delivery"

7.4.1 - Major Non Conformance??

2. During inspection of a Technical Support Department, which was conducted on 31 March 2013, we have asked to see the work instructions handbook which is being used from the staff. The Manager delivers a handbook, Version 4.0, Released on October 23, 2012. Later, the same day when we were with the Director of Quality Management we've asked him to show us the list of controlled system documents. We have located that this Handbook states that the current version is 4.1 on date March 14, 2013.

4.2.3 - Minor Non Conformance??

3. We are inspecting the Marketing Department of a Business and asking the processes that affect it. The Manager says that they really do not need any processes because their work needs flexibility. He also states that all staff are qualified and very well trained and, indeed the last twelve months, the
results of their work are very impressive. Checking the training records and the performance records of the Department we can verify the Manager's words.

4.1 - Major Non Conformance??

4. During an inspection of a company it has been verified that the company has halved the number of internal audits in the previous year. The Director of Quality Management explains that it was decided to carry out internal audits to all the applied processes, thereby broadening the scope and achieving approximately the same degree thorough and totalitarian control. Furthermore he said that they will have better results with this way.

Observation - to conduct more internal audits??

5. During inspection of the process of management review audit records we have checked the minutes of meetings of the last year (the firm had held three meetings during that time). It was detected that the "feedback from the client" was not included in the agendas. The Director of Quality Management stated that the company keeps a list of all records of customer complaints, to monitor them, but over a year they have not received any complaint. Therefore there is no relevant topic to discuss in the meeting with the management.

OK (no issue)??

6. During inspection of a company that manufactures cheap shoes we have asked informations for identification and traceability. The Production Manager told us that do not use methodology for identification nor for traceability of raw materials and products, since no client, so far, has not requested something similar or no need has been raised.

7.5.3 - Major Non Conformance??

7. During the inspection of the first stage it was found that the Quality Manual does not contain the Quality Policy of the Corporation. The Director of Quality Management told us that the Quality Policy is posted on the bulletin board and lead us there to show it. Moreover he explained that that the original document is held in the server (computer file).

OK (no issue) ??


Thank you in advance.
 
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#2
Re: Short case studies - major/minor non conformance, observation or OK?

I am only going to respond to one, for time's sake.

3. We are inspecting the Marketing Department of a Business and asking the processes that affect it. The Manager says that they really do not need any processes because their work needs flexibility. He also states that all staff are qualified and very well trained and, indeed the last twelve months, the
results of their work are very impressive. Checking the training records and the performance records of the Department we can verify the Manager's words.

First, I'm not sure I like the term "inspecting". But we will go there. I am also going to use some of my standard definitions, which may change your scenario. The term process, to me, designates an activity. The term procedure is the specified way to carry out a process and a work instruction is a step-by-step instruction on how to perform a task. Given those definitions, I am changing your statement "do not need any processes" to "do not need any procedures". The reason for this is marketing is an activity, therefore a process already. Given that:

Is there a requirement for marketing to have documented procedures or work instructions? It is not one of the mandated 6 procedures. Are they required by customer mandates? If not, are they mandated by the company documentation? If the answer to any of those is yes, you have a clear demonstrated failure and therefore a nonconformity.

But what if the answer to all is no? Now, we have to do some thinking. 4.2.1 d) states that your documentation must include all documents required to ensure effective planning, operation and control of its processes. So that leads us to some additional questions. Without the process being documented (procedures or work instructions) is there loss of control of the planning of the process? ... of the operation of the process? ... of the control of the process? Or we can reverse it and ask how the process is being effectively planned, operated and controlled without documentation? Is there evidence of process failure (or success) without the documentation?

It is hard to answer those questions in a hypothetical. The scenario may, in fact, be completely effective and not only conforming, but ideal. The scenario may also indicate a complete breakdown of that part of the system and warrant a major nonconformity (although I recommend not using majors and minors on internal audits)

my :2cents:
 
#3
Re: Short case studies - major/minor non conformance, observation or OK?

You may wish to research better written case studies! They are far from helpful in guiding someone who wishes to learn to be an auditor or improve skills. They lack clarity in many cases and you could concluded, as Dave suggests, that no issue exists, because of the details presented. As for whether something is a "major" or "minor" etc., it's going to be of no use, since the information isn't complete.
 
#4
Re: Short case studies - major/minor non conformance, observation or OK?

I agree with what's been said and also disagree with the term 'inspecting' & 'inspection' being used throughout these scenarios. One of the first things you learn as an auditor is that you're not an inspector.

I am more interested to knowing where you got these case studies from.
 
E

eekostas

#5
All, thank you for your answers and your time. These cases were taken from a greek site and they were translated by me in English -so apologies for any misunderstanding of few terms (inspect, process..).

They were in my native language and i guess the terms you are referring sounds in greek as they should but they were lost in translation.. :)

Unfortunately they do no have any more info. I just tried to see whether i can have a first assumption in each case reading these few lines but i can understand that they lack clarity as Dave & AndyN mentioned and we cannot have a clear view.
 
#6
Re: Short case studies - major/minor non conformance, observation or OK?

I am only going to respond to one, for time's sake
Good idea. :agree1:

Ok, I'll pick no 7, then: To my knowledge there is no requirement (4.2.2) to include the policy in the Manual, though it is a good idea and most of us do. Furthermore, the Quality Director could show the auditor where the policy had been posted, which goes some way to satisfy 5.3b: (The policy has been communicated. whether it is understood or not is not evident from the data provided). Not only no issue, but in fact fully satisfactory thus far.

/Claes
 
W

Wilderness Woody

#8
Hello again,

i have some short case studies which i found over the net and i would like your help to clarify if they are cases of non conformarce or NOT. As i wrote in my third (only) post, i believe that through examples can learn a lot. I would appreciate any help.

1. During inspection of a warehouse of a firm, we have checked the returnable material / raw material file to the suppliers. It had been identified that a specific supplier is delivering a large number of non-compliant and damaged materials. Asking the Manager of the warehouse to inform us of the actions he took in order to address the situation, he said "I just send them back and wait for a replacement, with the next delivery"

7.4.1 - Major Non Conformance?? .
As AndyN stated "They lack clarity in many cases and you could concluded, as Dave suggests, that no issue exists, because of the details presented. "

This example could go either way? several majors (serious breakdown of QMS) or nothing at all.

There are situations in industries where RAW or MINIMALLY PROCESSED materials are supplied to manufacturers who may sort and grade them. Substandard products then are routinely returned for recycling, reprocessing, regraded or disposed of. As long as the supplier and customer in agreement of the relationship, this may be just fine? just a part of the process.

One persons' understanding of " a large number of non-compliant and damaged materials " may be very different than another's. Quality professionals are taught from the beginning that "Zero Defects" is the ultimate goal and sure it's something to reach for! However, diminishing returns on process improvement and current state of the art may plateau efforts at a given point.

If this were a medical device or industrial machine control product, then the situation begs to "send in the hounds" and sniff out all the FAILURE they can? where is the RMA!, SCARs!, Quality Acceptance data!, what does the SQE (Supplier Quality Engineer) have to say about repeated performance issues and what alternate suppliers are on deck etc.
:deadhorse:

You can ask the Manager to explain / show that his actions match the Quality Plan establish for acceptance of that product from that supplier. :rolleyes:
 
W

Wilderness Woody

#9
Might as well comment on another one...

6. During inspection of a company that manufactures cheap shoes we have asked informations for identification and traceability. The Production Manager told us that do not use methodology for identification nor for traceability of raw materials and products, since no client, so far, has not requested something similar or no need has been raised.

7.5.3 - Major Non Conformance??
ID and TRACE are different from each other.

As ISO 9001 standard states " The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization ".

ID? raw materials and in-process components through finished product need to be identifiable by the staff / systems in terms of WHAT the product is and acceptance/completion STATUS at any given time.

In this case? maybe there are different eyelet designs with only slightly different appearances and you don't want to mix them up? You need to identify the inventory somehow? colored buckets, labels on bags, specific stock bins etc.

Say one part of the production requires a heat treatment or sealcoat applications? perhaps the casual glance or touch of the object cannot readily disclose that the product has already been through the process? You need to have some method to identify that this bunch of parts are ready for the next operation "XYZ", but those others over there are only ready for "ABC" operation.

Process staging, points of inspection and acceptance can be managed in continuous, batches or even single items if it needed and planned for.

Perhaps these are REALLY CHEAP shoes? like flip-flops. There are still at least (2) components and unless they only make a single size, they need to identify the difference between sizes right? The simpler the product / process, the easier it would be to document how "Identification" in achieved.

TRACE? per ISO 9001 standard " Where traceability is a requirement?" can invoke a whole lot of activity and baggage depending upon how complex the finished product is. It is typically used when the opportunity for contamination and harm from failures is high. Medical device, Pharma, Food and critical equipment rate high on this scale as failures can be deadly or widespread harm. You only do TRACE when there is justification to require it, not for fun!

Costs and time for Trace activities and record-keeping to meet the ISO 9001 standard requirement of "?shall control the unique identification of the product and maintain records " must be built into the product realization. Raw material certifications, analysis, verification, in-process testing, failure analysis including regular life-cycle or accelerated failure testing can required with the goal of being able to recall product in the field if trends indicate a problem.
 

drgnrider

Quite Involved in Discussions
#10
Unfortunately they do no have any more info. I just tried to see whether i can have a first assumption in each case reading these few lines but i can understand that they lack clarity as Dave & AndyN mentioned and we cannot have a clear view.
Similar to "db" setting definitions, as I inform my auditors... we are looking at: either 'yes' or 'no' it meets what we are being told the process is or following the written process; no assumptions, no 'I feel', no 'it looks like', etc. If we cannot definitely say 'yes' or 'no' we cannot assign a non-conformance.

:2cents:
 
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