Internal Audit Case File Classification

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Internal Auditor: Case File Internal Audit
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by Norman Huston - Monday, January 26, 2009, 12:53 PM
Clause 7.5.3 Identification and Traceability During internal audit the company was given a observation reported against standard Clause 7.5.3. The write up was stock located in machine shop area not identified as to current status. corrective action: Labels were placed on the shelves in the machine shop storage room labeled "Parts ready for integration". A paragraph was added to our procedures manual/procedures to cover this area. The corrective action was prepared, submitted, accepted and verified by the Auditor. Question: Should this have been classified as a observation or should it have been a minor or major non conformance? I believe it was a minor as there was few parts and you could easily tell by looking at these particular parts if they were new, used or non conforming. What do you think?
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by Asif Masiuddin - Tuesday, January 27, 2009, 12:43 AM
It should be a minor NCR since the corrective action was initiated. If proper labels were available even though the stock located in machine shop area not identified with current status then it should have been an observation.
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by Siva Reddy koppala - Thursday, January 29, 2009, 10:08 PM
It is a major NCR,as the stock can be of different drawing and material specification.Each item should have unique Identification tag ,indicating customer name ,purchase order number, part description,drawing number,serial number and the test status.In the casting Industry,heat number is punched or"as cast" on each casting for Identification and traceability. The QMS has to be made error-proofing.
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by PRATIK NAYEK - Saturday, May 7, 2011, 01:23 PM
Working with my org was a great experience and showed and important characteristics of an internal auditor that verification and vouching must go hand in hand though vouching is a bit more to work upon and be accurate ,but its a fact that unless there is proper vouching their cant be verification of assets and liabilities.i had to identify a lot of vouchers and also to take notice about the report that ill have to submit at the end
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by Jayesh M.P. - Thursday, March 5, 2009, 12:11 AM
clause 7.5.3 Identification and traceability, begin with "where appropriate, the organization shall identify the product by suitable means through out the product realization. where traceability is a requirement...." Internal auditor should be correct. Beacuse traceability may not be requirement in this case. Auditor raised it as an observation to give an opputunity to auditee to check the appropriateness of identfying the mentioned material. Auditor must have observed that even in the absence of identification also people concerned are aware of the situation because of the features like limited number of parts, competence of personnel in the shop etc. However it is raised as observation because providing identification will be an improvement and if properly acted at this time, in future when more number/ types of parts arrive at the place it may not cause a non conforming situation.
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by Konstantina Dimitrova - Tuesday, January 11, 2011, 12:10 PM
I agree with you- Beacuse traceability may not be requirement in this case The auditor does an observation to permitting the auditee to prove the suitability of those using material. Identification of the status of product / detail in monitoring every detail / is the core of any good quality system.
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by Roberto Decano Asuncion II - Thursday, March 5, 2009, 07:56 AM
I should say that this serves as a major NCR. "Where appropriate", they should established procedures to identify products and determine what particular parts or other specifications are used as it moves through manufacturing, delivery and installation. Individual products or batches of products must have unique serial identifications for assuring product quality necessities.The identification must be recorded as a quality records. Eventhough corrective action was initiated for proper labeling for all the stock items individually or by batch located on the shelves, it should be classified as an observation.
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by Sunita Shakya - Thursday, March 26, 2009, 10:48 PM
Definitely, i say this is a major NCR. Activity wihin the room must coincide with the status label presented..Anyways after the immediate corrective action is done, it can be considered as an observation..
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by Varadarajan Srinivasan - Sunday, April 19, 2009, 12:57 AM
Hi Norman Just imagine a critical item placed with label and without label. The traceability is high in the second case. Hence clarity with respect to the process is high. Even without a tecnical person (say a helper in the stores) any one can help when urgently needed. it is the sense of purpose rather than following mere textual procedural implementations. In this context observation is appropriate.
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by Patrick McConkey - Tuesday, April 21, 2009, 10:16 AM
My thinking is that this should be a "minor" finding. Although the part status could be determined visually as you stated and the risk would be low for a flow down of suspect parts the procedure did have to be revised to explain how to store or identify the parts during processing. The fact that the procedure had to be revised would indicate to me that this was more than an observation. pmcc
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by Surendra Kumar Tomar - Monday, April 27, 2009, 12:44 PM
I think it should be minor NC as various products may be at shop floor for various purpose. Status of each product should be labled to identify the purpose of product laying on floor.
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by Tariq Khan - Friday, January 15, 2010, 03:58 AM
I agree with Surendra Kumar Tomar it is minor NCR,but it requires another unscheduled Audit in order to find that the problem is resolved,because if the problem is not fully resolved it will shape in to Major NCR,at any stage and time.
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by Paul James - Wednesday, June 3, 2009, 09:07 AM
Its a minor NCR since the corrective action was mentioned and corrected. as this was stated in the procedure . corrective action was done and submitted
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by AMIT CHADDHA - Monday, June 22, 2009, 01:12 PM
It should be a major NCR. Stock might be of different drawing and material specification and every item should have seperate and identical Identification tag which should be in unique, PO, Customer name, Item description etc. Quality Management System has to be made error-proofing by using lean methodology.
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by Archana Grover - Sunday, September 20, 2009, 11:57 PM
Background:Audit was conducted in a company. The below given observation was made in the machine shop storage room. Observation: It was found that the running stock was not labelled. Classification:The NC is a major one. The ISO clause 7.5.3 clearly states that"Where appropriate", the organisation should established procedures to identify products and determine what particular parts or other specifications are used as the product moves through manufacturing, delivery and installation." Individual products or batches of products must have unique serial identifications for assuring product quality necessities.The identification must be recorded in the quality records Clause No.; ISO clause 7.5.3
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by Mazhar Ansari - Sunday, October 9, 2011, 05:07 AM
You are absolutely right. I agree with your reply.

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by Simanga Moyo - Tuesday, September 22, 2009, 07:08 AM
I think it shoud be a Major Non conformity because there is a risk of non conforming parts finding their way into our production system.The implementation of a Quality Management Sytem is focussed on improving the way operations are done and thus enhance customer satisfaction at a lower cost.Thus besides technical aspects due consideration should be given to the impact of such a situation on worker morale. Even though an experienced operator can tell the status of the parts by merely looking at them the same would not apply to an apprentice.It is thus prudent to segregate the parts by their status so as to simplify their disposition.This would save on time and frustration on the person doing the work not to mention other hidden costs. Regards Simanga Moyo
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by Ananda Beloshe - Thursday, November 19, 2009, 11:02 PM
It is major NC. There should be Identification & traceability for each items in organization specially in shop floor. If they were few in qty then also it should be identified. In absence of any knowing person others should get information about that parts. So that work flow should continue.
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by Marlon Jaftha - Monday, November 23, 2009, 05:45 AM
lets say someone who did not know the parts, took it and used it assuming it was something else cause engineering parts are so similar to each other and the difference could only be seen by means of dimensional measurment...for example a 1,2mm drill bit opposed to a 1mm drill bit. it would have resulted in scrap or work efforts going to waiste. or using the wrong tool for something else could have resulted in personal injury or even damage to the machine or tool that it has been used on...then the effects would have been major?
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by B Schreurs - Tuesday, November 24, 2009, 07:15 AM
To solve this issue without having large costs involved. In the past we were also dealing with these items. We found out that a sort of Kan Ban system was working quite well. Instead of having only a barcode an written information we also have a clear picture on the kanban card. The operators easlily can compare the product with the picture. This kanban card is faxed to the supplier and also in the incomming goods, they can compare the picture. In the begin it cost some time with the digital pictures. But now when a new product enters the warehouse, it is easy to make the kanban card.
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by B Schreurs - Thursday, November 26, 2009, 06:54 AM
During an external audit the machines were running and the raw material were used. Unfortunately we found that labels and lot numbers were not collected by the operator. So the tracebility was gone .... and that observation with an external audit. we did not define how deep the tracebility must be. Is it ok if we can see that in that week we used that raw material or is it ok if we can see that in the minute is that raw material used. In case of a recall we prefere each minute, but due to the missing
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definition, we could trace from week to week. That statement was ok for the auditor.
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by Manoj Krishnan - Friday, November 27, 2009, 04:02 AM
Dear All Iam an IQAuditor of one fmcg company.we have the Policies of quality policy,food safety policy,environmental policy,jewellary policy,glass policy.for the fmcg firms they have to focus and concentrate more on the product quality. We have one team for the food safety.it is known as "Food Safety Team".We have the HACCP team also .Iam one of the member of both.for this HACCP we have the procedure of tracibility.It is keeping by our Quality Control Deptmt.For any product which is before unloding ,before filling and packing ,before despatching Q.C is analysing the sample of product and make the report.If any problem then they will reject the consignment.and for the packaged producs we are following the Lot no,Batch no,Month and date of packing,MRP for tracing the products..Bcs of this we can trace the product easily.
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by Anju Menon - Saturday, December 5, 2009, 02:50 AM
I think it should be a major non conformance,as any product within the specified guidelines needs to be properly labelled as per the law.If an instance if the same was identified in a drug company i will say it definitely will be a major non conformance,situationally it looks as if the product is not considered by the auditor as a major concern due to the fact that it was not causing a serious threat and thats probably the reason it was taken as an observation.However different products no matter how small should be properly sealed and packaged in with proper labelling.
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by Muhammad Naeem Anjum - Monday, January 4, 2010, 01:46 PM
I agree that this was a NC however it has no physical existance after the corrective action taken and varification by auditor. So i think that this NC was closed and did not treated or repoted now as a NC after its closure.
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by BENON MUTAREMWA TUMWEBAZE - Thursday, January 28, 2010, 07:31 AM
Traceability,when mentioned in quality assurance,me i look at it as the capacity of the organization to look bottle necks that would affect the quality of their services and products.Record management and documentation becomes crucial so for the case of this machine shop,there should be clear evidence of which machine part has been replaced,which are knew, with all the details of replacement, by who, when, because am not sure if someone will tell whether the part was once used by just looking at it, or tell which part was replaced and how long it has stayed on the shelves.to me it is very important to label that part as this will save the company time. To me this is a major ncr otherwise you might find even old parts are being used again which will cost the company in the long run.for am alab pesonel labeling is important as is diagnosis you mis label your sample then you missdiagnose the case and you put the patient at risk
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by susy nunes - Tuesday, May 18, 2010, 10:52 AM
I have to say I consider this to be a Minor non-conformance when you consider that as per Norman it is easy to decifer the condition of the parts based on their appearance, however I am a firm believer in documenting the status of a part as you go. While the condition of the part may be obvious to you, it may not be to others, so why not avoid the ambiguity by identifying the status of all parts so that everyone is made aware. Traceability and identification are key to ensuring that the right steps are being done to the right parts. Different Clients may require different specs. Why leave room for error. Since the corrective action to identify the status of parts located in the machine shop, and newwritten procedures were implemented to ensure future practice, it would stand to reason that there would be no recurrence of this type during any future
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internal audits. Follow up would be adviseable to establish the effectiveness of the new policy.
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by KOLAWOLE GBENGA .S. - Wednesday, August 25, 2010, 11:22 AM
This case is a Minor NCR. According to the Auditing fundamentals, "Auditing is systemic,independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit creteria are fulfiled" This means that one of the purpose of auditing is to establish,document,implement and maintain the documented procedures. Also, if the process is checked and corrected, I believe that the quality of the products produce will be marketable. Hence, the consumers will be able to enjoy what they are buying and be able to request for more. Therefore, it is fair for the Auditor to be independent and unbiased in his engagement.
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by Jeff Ferrier - Wednesday, September 29, 2010, 03:06 PM
We have never been dinged for something this minor. It seems that if the sub components were in the operators control that labeling them would be redundant. However I think any nonconforming parts would need identified.
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by estefanio rubin jr - Sunday, October 24, 2010, 09:20 AM
I think it was a major NCR because as what i observe during audit the proper place of putting important details in your product, it should be properly put in distinguished area for what the procedure and specification said.
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by gurmeet singh - Friday, December 10, 2010, 08:17 AM
Background of the problem was founding of material on shop floor without tags Observation & Classification :i think that it should be considered as major NC .becouse if there was some materials without tags than it be in case there was a mix of materials .and mix material with tag also is a NC. so it should be considered as major clouse ISO 7.5.3
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by Syed Mohammad Ali Rizvi - Thursday, April 21, 2011, 03:59 AM
Where appropriate, the organization shall identify the product by suitable means throughout product realization. The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization.
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by dinesh kumar - Wednesday, July 13, 2011, 10:06 AM
It is a major NCR,as the stock can be of different thing and material specification.Each item should have single Identification
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tag ,indicating product name,purchase order number, part description,serial number and the test status.In the pharma Industry,grn no. is pasted for Identification and traceability.
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by Rafael Garcia - Wednesday, July 27, 2011, 09:22 PM
I would have to consider it a major non-comformance. Each and every part is very important to the end product. Each part in that shop should be identified and labeled accordingly. Imagine the major profit loss and down time if the line had to stop and repair a whole days worth of production because the non-labled, non-identified material was substituted or omitted? Thanks.
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by Nehal Hasan - Thursday, September 8, 2011, 04:28 AM
I think it is a major non conformance because I think if you are seeking for proper quality every part should be identified and labelled and never account on personal own evaluation to things whether it looks new or not because from here mistakes usually arises.
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by Radheyshyam Sharma - Saturday, September 10, 2011, 04:57 AM
Identification of the materials is compulsorily. this may be taken as major no conformance. But the corrective action is taken immediately and the same is verified and approved by the auditor, so it can be noted as just an observation.
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by Deebha Vasanthakumar - Friday, October 28, 2011, 09:32 AM
Hi, According to me is a Major NCR. After the products is packed in a bag / box, a label should be placed on it. That label should contain, i) Parts name ii) Machine no iii) packaging size iv) Operator name v) QC Inspector name vi)Date & Shift If all the details is available then we easy say the Process flow of the product and its avoids lot of confusions for auditing team as well as new comers. So, Identification & Traceability is very important one. Thanks & Regards, Deebha
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by Victoria Foran - Monday, October 31, 2011, 09:49 AM
It depends if the material was for maintenance or for production. If the material was for production, then yes it should have been a CAR. If the material was for maintenance, then it should have been an observation.
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by Arif Ashfaque - Saturday, November 19, 2011, 12:03 AM
Dear Huston, You are right that its minor as in the clause 7.5.3 it has mentioned two point related to this. 1.Identify status with respect to measurement throughout the product. 2.Wheretracability required,then control the unique identity of product. So i also think that as per above it is bettre to go through procedure. Thanks,
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by Odirile Akanyang - Friday, December 16, 2011, 08:09 AM
Dear Norman,
I would like to say that this is a major non-conformity. It is appropriate for the product to be identified in this scenario because the company do use store or control the physical products, hence this becomes a requirement where by the following activities needs to be followed creating the identity
and type of products, preserving the identity and status of products, sustaining records of serial or batch numbers.
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by OGOCHUKWU ADAOBI OKUEFUNA - Wednesday, December 21, 2011, 08:11 AM
Hi Norman, I will classify it as a minor NC because according to internal audit handbook; A minor Nc that be defined as a failure to meet one requirement of a clause of the standard or a single observed lapse in following one item of a company procedure. It was observed that stock located in machine shop area not identified as to current status, a correction action was take that is, labels were placed in the machine shop storage room labelled "part ready for integration. That is to a single lap was observed and was corrected.
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by Jose E Kunhardt - Sunday, January 1, 2012, 07:01 PM
Based on the industry that i work, this could be consider a Major discrepancy. The discrepancy had to be mitigated immediately and you had to add new procedures/controls to your manual. If it would have been a minor discrepancy, no procedures to handle the incident had to be written and the issue could have been addressed at a later time.
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by Dawn Parks - Tuesday, January 24, 2012, 12:58 AM
This should in my opinion from my experience this should have been wrote up as a minor , to correct this minor all parts should have been segreated to a area that was labeled and identied properley. And not with potential of the parts getting mixed in with other parts which could cause confusion or plain lack of organazation.
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by Scott Summers - Thursday, February 2, 2012, 02:08 PM
Yes, this should have been written up as a minor. All product must be identified throughout the manufacturing process. Just because you might know what it is, doesn't mean that any one else would know what it is.
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by Abelardo Bacanto - Thursday, February 9, 2012, 08:35 AM
For me, i will clasify this as an observation, because a corrective action has been initiated after the notification to the company, prepared, submitted, verified and accepted by the auditor as compliance.
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by Anna Liza Dela Cruz - Friday, June 8, 2012, 05:40 AM
Background: Internal Audit of warehouse Observation: Some of the products were found with labels but no batch number. Classification: I think that it should be considered as major nonconformity because it is stated in the standard that the organization shall identify the product by suitable means throughout the product realization, where traceability is a requirement. Traceability is very important especially for product recall. ISO 9001:2008 Clause 7.5.3. Identification and Traceability
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by Cindy John - Tuesday, September 4, 2012, 04:38 PM
I believe it should have been a minor nonconformity because the product was not identified at all. If it was left on the floor at the end of a shift and another person starting the next shift, they would not know what part they were using, or if the prior operator was having a problem and left a non-conforming part on the floor to re-examine the next day. If there was no testing involved, it could have been delivery to the customer.
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by cherian renosh - Thursday, September 6, 2012, 02:30 AM
dear sir in our origination one real experience for me in the time of audit . i am the person to Gide the third party auditor . first he asked to show all the test certificates.their after he asked to show all raw materials Report .he checked all the reports and he noted some heat number and coil no .and PO number drawing numbers .and we both went to work spot he asked to show all the visual inspection reports . conducted during packing .and we showed . and he said i want to check the traceability .of the product i showed him all the report traceability . and after that he asked to show the internal audit report . i showed him .he checked . after that he asked selected one product random from box . and he asked to do visual inspection in front of him as u do in final stage. worker showed inspection process. after that he started checking printing on the product . matching the heat number and coil number .after that he asked the rejection data in process . we showed all the data. and he told some verbal e suggestion to improve the process
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by cherian renosh - Thursday, September 6, 2012, 02:32 AM
once External audit fail once i am the person to guide the auditor . he check all the perimeter according to the product . after that he caught that lot number not matching in on line report and physically on the product . he hold all the finished product . asked to check all the mechanical test . in front of him . mechanical test failed unfortunately he rejected total lot . and after the meeting management decided to reject the material . and taken corrective action that never happens
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by Sanjay Kumar - Thursday, September 13, 2012, 11:14 AM
This case can be categorised as a major NC as the manual / procedure did not cover this clause which is is a requirement for the said department.As per clause 7.5.3 of ISO 9001-2008 which states - where traceability is a requirement , the organisation shall control the unique identification of the product & maintain records.
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by Fizza Momna - Saturday, September 15, 2012, 01:22 AM
Clause 7.5.3 Identification and Traceability Yes somewhat similar case is with me, during internal audit when i arrived in machine shop of our company, i found neither information was provided for the machining of product nor any traceability could be done. so should i have had raised NC over there??
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by Anthony Oluoch - Sunday, September 16, 2012, 03:33 AM
Minor non conformity by definition is non fulfillment of requirement. the stalk was located in machine shop area and lacked identification. This leaves a lot of untied ends; was the stalk at the right place and time, could the stalk be out-rightly identified by a second or third party, all the answers to which is no, a non fulfillment of requirement. Should such an observation be made in a preceding audit, this should constitute a major non conformity.
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by Oyaifo Kashetu - Wednesday, October 17, 2012, 09:20 AM
I think it should be a Major Non conformity because unidentified parts were found on the shelves.The implementation of a Quality Management System is to improved the way operations are done and enhance customer satisfaction at a lower cost for products.In this regard all the specification and requirement are to be followed. Because an experienced operator can tell the status of the parts by merely looking at them,that the same would apply to an apprentice who have just started work.Since some of this requirement was not met,it implies that there was major non conformance.Thanks
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by Jennifer Van Horn - Monday, January 14, 2013, 09:22 PM
I would consider this a minor non-conformance, due to the fact that all products must be identified during the process steps, especially work in progress. To ensure this happens, a document/record trail must follow to prove all the necessary steps have been taken during the process. An unqualified person could easliy mis-identify the parts and release to production, distribution or disposition, without knowing the proper procedure and and without knowing how to record/identify the parts information. Could result in recalling suspect products that were mistakenly released or loss of revenue if unnecessarily disposed.
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by Caleb Chirimunjiri - Thursday, January 17, 2013, 01:50 AM
I think by giving you the allowance of placing the writting can allow you to comply. This was a non-conformity before you placed the writting. I think its fine by me. Auditors can do that if they feel its minor and can easily be corrected. At my company we had such case when the auditor asked us to correct something and we did and complied.
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by Kyaw Lin Htoo - Saturday, January 19, 2013, 11:35 PM
Identification and Traceabality Back Ground-Internal audit field work in the storage area Observation- Stock and materials location are not properly identified Classification- This case must rise up the minor NCR for process improvement As 9001:2008 (Clause 7.5.3) Control of record is required before deliver to customer. According to control of record procedure, there should be state the label or marking by authorized person as part by part. So that can be tracing back the balance materials and unused materials. The purchaser could evaluate the ordering materials and the storage area when the traceabality record is in hand. CAR to be done properly and close the file.
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