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Internal-Auditor.com's

Scenario Question-of-the-Month 

This page houses past scenarios. Please feel free to comment on them if your wish!

The rules:

1. Read the scenario below;
2. Decide if a non-conformance exists
3. Decide what element you would apply the non-conformance to.
4. Email us with the answer. Look in our newsletter for the answers

Feel free to answer past questions as well! If you feel daring, submit a scenario!


2003 Scenarios

January's question:

The procedure for internal auditing states: “All corrective actions generated through internal auditing will be evaluated for effectiveness during the next internal audit following the close of the corrective action.” You notice that several corrective actions were verified by the manager of the department responsible for the corrective action. When asked about this, you are told that the procedure did not say “who” was to verify the corrective action. The corrective actions were evaluated, as per the procedure, even though no internal auditor performed the evaluation.

Is this conforming, or non-conforming? Let's hear from you!


February's question:

You are auditing corrective actions. One sample you examine deals with a complaint of product being damaged during shipping. The CA team determined that the crates were not strong enough and the CA was to add additional bracing to the crates. In the report was an email from one of the team members stating he did not feel the CA addressed the root cause. He feels that the root cause is systemic in that the sales department is not determining how the customer, or the trucking companies handle the product. Although this worked on the current complaint, it will not stop the complaint from occurring on other products. There is no record of a response from anyone else on the team, and there is no record of any discussions in any agendas or meeting minutes.

Is this conforming, or non-conforming? Let's hear from you!

There should be some information as to what was included in the investigation to determine if the root cause analysis was adequate.  In other words, what was the basis for the conclusions of the disagreeing members?

This could be a nonconformance if the procedure for corrective action does not "define the requirements for reviewing corrective actions taken.",  as required in 8.5.2 (f).  If the requirements are defined and there is evidence that the requirements are met, then I don't believe there is a nonconformance. 

David A. Oleson, CQA
Lead Internal Auditor
USF Consumer & Commercial WaterGroup


March's question:

You have just begun the transition to auditing by processes. You are planning to audit sales, because that is the first identified process of the organization. A week prior to the audit, you have a meeting with the Management Rep and the Sales Director. They have worked hard to understand the sales process and have a detailed process map. They also developed a procedure, because they felt it was important. They hand you a "Process Binder" with all of the data related to the process identified by tabs. One tab is marked "Checklist". When you ask about this, the Sales Director states that as they developed the process and procedure, she generated a checklist for use during the internal audits. She also feels that you should be able to audit against this list without any additional modifications from you.

Is this conforming, or non-conforming? Let's hear from you!

If the checklist conflicts with the internal audit procedures it should not be used.  It is up to the internal audit function to develop any working papers necessary to perform the audit.  I don't believe this constitutes a nonconformance. 

David A. Oleson, CQA
Lead Internal Auditor
USF Consumer & Commercial WaterGroup


April's question:

You are auditing the sales process, which includes customer-related processes. The sales manager shows you a "process map" of the sales process that includes formal contract review and feasibility studies. Participants of this review are sales, purchasing, maintenance and production. Engineering is only included if there are any special design requirements, something that happens rarely. You are also shown three different types of output document templates, one for each type of job your perform. Because you read the Internal-Auditor.com newsletter, you ask how customer requirements are determined. The sales manager states that customer requirements are determined during the sales process and that information is collected on a checklist. The checklist is part of the formal review. Each person initials their portion of the checklist to ensure all requirements are determined and understood. You notice that every form has initials by engineering. The sales manager states that if the engineer is not involved, the quality manager will initial the form after the meeting.

Is this conforming, or non-conforming? Let's hear from you!


May's question:

You are auditing the purchasing process. There is a documented procedure, an associated work instruction and a supplier survey form outlining the method used for evaluating suppliers. The work instruction details the process used to fill in the form. The form contains several questions relating to the supplier's QMS. It also contains a place to fill in key measurables of supplier performance such as; on-time delivery, quality measures and price. The procedure states that this information is used to determine if the supplier remains on the Approved Supplier List. While examining the supplier records, you notice that in many cases, not every field on the form in filled in. When asked about this, the Purchasing Manager states that for the most part suppliers maintain 100 % on-time delivery and zero defects. Only when this is not the case, will the information be entered. It is much easier to track the exceptions, rather than the rule.

Is this conforming, or non-conforming? Let's hear from you!

If the procedure or work instruction requires that these fields be filled and in many cases they are not, then this would be a nonconformance to the document that states the requirement.

David A. Oleson, CQA
Lead Internal Auditor
USF Consumer & Commercial WaterGroup
I would write this up as a non-conformance. I would also suggest that the work flow be re-evaluated and update either the process that is followed or update the work instruction to reflect the process that is being used.

Michelle
I'm not keen to ping someone who is essentially trying to do the correct thing.  If the auditee puts hand on heart to either change the form, work instruction and procedure or fill out all the requirements on the current form, then I'd include this item as an observation / opportunity for improvement.

If the auditee refused to conform I would raise the item as a nonconformance

David Mullins
Quality Assurance Manager
Bridgestone Australia Limited


June's question:

You are performing the first systems audit, and beginning with Clause 4. Specifically, 4.1. You ask about the identified processes, and how your company identified them. The Management Representative (your boss) states that she analyzed the organizational business plan, and derived the processes from that. From there, she mapped the processes (you've seen the maps dozens of times), indicating the relationships and listing the inputs, outputs and metrics. In the Quality Manual, everything is laid out so all of the 4.1 a) through f) is clearly referenced. Heat treating is the only outsourced process, and it is included as well. She indicated she presented this to management at the first management review meeting, where they adopted the process description. A review of the meeting minutes reveals that they were on the agenda, however the minutes do not reflect that the processes were adopted by management.

Is this conforming, or non-conforming? Let's hear from you!

I would write this nonconformance against 4.2.3 since there is no record that the documents have been formally approved

Russ Bauer-ISO/QS 9000 Mgmt. Rep. 
Biddle Precision Components

If the manual (which describes the processes) has been approved by the designated authorities as described in the document control procedures, that would be the basis for approval.  However, M.R. agenda item not being addressed in records could be a problem if this is not an isolated incident.

David A. Oleson, CQA
Lead Internal Auditor
USF Consumer & Commercial WaterGroup

July's question:

For some reason a family of raccoons have taken up residence above the shipping doors. Considering you only run one shift, they don't seem to get in the way much. In fact some of the shipping crew has been known to leave food out for them. They do however, from time to time leave messes in the loading dock area, and once got into the building and damages some shipping containers. They have not damaged any property. 

You are the Lead Auditor, and one of the auditor wants to write a nonconformance to 6.4 Work environment, stating that the potential for damage and that the raccoons pose a health risk.

Is this conforming, or non-conforming? Let's hear from you!

I would write this against 7.5.5 because the company has not preserved the packaging of the product which could allow the product to be damaged

Russ Bauer-ISO/QS 9000 Mgmt. Rep. 
Biddle Precision Components

I've given some consideration to the raccoon scenario and believe the internal auditor in question is "barking up the wrong tree".  I'm not convinced that the raccoons are necessarily creating an unsuitable work environment (ISO9k2k - 6.4).  The fact that the shipping crew leaves food for these raccoons indicates that they don't seem to mind having them around.  In fact if the shipping crew enjoy having wildlife around then the situation with the raccoons may actually have a positive impact on employee morale, efficiency and the overall corporate culture.  By suggesting that the presence of these critters is automatically creating an unsuitable work environment invites an adversarial attitude between manufacturing and nature (which kind of flies in the face of corporate social responsibility, ISO-14001 etc.).

That's not to say there isn't a nonconformance here.  The evidence of "messes" and damaged packaging suggest that the organization is not taking adequate steps to preserve and protect their product (ISO9k2k - 7.5.5). Hypothetically if the organization can devise a way to keep the raccoons and safe guard the workers and the product then I wouldn't have a problem with the presence of raccoons.  But I would steer clear of calling it an unsuitable work environment and would simply issue a nonconformance for failure to adequately preserve product (7.5.5).

Mark Evans
I believe writing a nonconformance is appropriate.

David A. Oleson, CQA
Lead Internal Auditor
USF Consumer & Commercial WaterGroup

August's question:

You are the company's Lead Auditor. One of your internal auditors is auditing one of your manufacturing processes. This particular process involves sending parts out to be heat treated. Once they are heat treated, they are then further processed. Your auditor reports that there is no record of the heat treater's processes ever being audited. The auditor seems to feel that this is a violation of 4.1, specifically: "Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes." All of the other sub-processes used in this product are required (by company documents) to be strictly controlled. Select metrics are developed for each sub-process and the sub-processes are monitored daily. The auditor believes that this same operational control needs to be applied to the outsourced process as well.

Is this conforming, or non-conforming? Let's hear from you!

I agree with the auditor on 4.1. However, it also could be written against 8.2.4 because they fail to maintain "evidence of conformity with the acceptance criteria".

Russ Bauer-ISO/QS 9000 Mgmt. Rep. 
Biddle Precision Components

This is not a nonconformance.  The company is only required to ensure control over outsourced processes and identify the controls in the QMS.

David A. Oleson, CQA
Lead Internal Auditor
USF Consumer & Commercial WaterGroup

September's question:

While auditing your document control process, you notice that some documents are identified by name and some with a document identification number. The procedure does not specify either, and the document control clerk indicates that the decision is up to the process owner. Some of the process owners want the documents to be known by the name of the document, others want a number. You believe that this could result in confusion with the operators using the documents. 

Is this conforming, or non-conforming? Let's hear from you!

This is non conforming as there is no consistency. Each of the document is designated to have an unique code which is faulted here.

Ajit Basrur
I don't believe this scenario constitutes a nonconformance to ISO 9001:2000, as long as the procedures are included in the manual or referenced in the manual.  The standard does not require a specific convention for document identification.  As long as the users can demonstrate that they can readily access the procedures there is no problem, however, I would write an observation indicating a potential for confusion by a lack of consistency in identifying procedures

David A. Oleson, CQA
Lead Internal Auditor
USF Consumer & Commercial WaterGroup

October's question:

Your company moved to a new location six months ago.  While conducting an audit of the Calibration Lab, you observe the Calibration Techs using a worksheet to verify calibration. These worksheets are required by your customer, and copies are sent to the customer. You notice that the address on the worksheet is the old address. When asked, the Calibration Manager states that the calibration data is correct, and they will start using sheets with the new address when the existing stock is depleted. 

Is this conforming, or non-conforming? Let's hear from you!


November's question:

While auditing the record keeping process, you notice a stack of records laying on a desk. All of these records are very old, and way past their expiration date. In fact they should have been destroyed two years ago. When asked about this, the Records Custodian states that these particular records fell behind a large file cabinet when they were being purged two years ago. Last week, during remodeling, they were recovered. They are now sitting on the desk, awaiting disposition with the regularly scheduled records to be disposed of at the end of the month.

Is this conforming, or non-conforming? Let's hear from you!


December's question:

You are auditing your company's process for receiving inspection. Most of the material you buy is classified as "commodity".  Commodity items are generally brand name items that can be purchased from any number of locations. Receiving inspection is basically checking the product name, part number and quantity. The boxes are never opened, and the material is never checked. The receiving clerk states that the operators know what the material is supposed to look like because they use so much and would know if there is anything wrong with the material. The only record of the inspection is the receiving clerk's initials on the incoming shipper.

Is this conforming, or non-conforming? Let's hear from you!


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All rights reserved Ruth Ellen Carey Communications 2000-2004
All Questions should be addressed to the Lead Auditor at Internal-Auditor.com

Last updated: July 08, 2004.