ISO 9001:2015 Internal Audit

Case Study

50 points total (10 points for each part)

A quality auditor, Mr Jones, is visiting Air Technical Publications Limited to assess them against the requirements of ISO 9001:2015. Read the description of the assessment and identify any unsatisfactory areas where the auditor would report problems.

Open the ISO 9001-2015 Internal Audit Checklist.doc file in the Quality Management Systems assignment folder and complete the following:

• For applicable questions, indicate whether the company is in compliance or not by responding Y or N in the third column. If there is evidence of compliance, please indicate what that it. If there is a deficiency, provide actions that are needed to comply with the standard.
• Any section of the standard that does not apply can be removed from the document before submitting.

PART 1 - INTERVIEW WITH THE QUALITY MANAGER

Mr Jones met Jim, the Company Quality Manager in the conference room at 9:00 am to confirm the audit program for the day. Before starting, Mr Jones asked to see the Quality Manual. After looking at it for a few minutes he commented that the organization chart on page 3 was different from the one that he had been shown earlier by the company Managing Director.

Mr Jones then asked to see the Companys internal quality audit records. He looked at a sample of the audit reports and was satisfied that these were well documented. However, when he referred to the Annual Internal Quality Audit Plan it was clear that a number of the scheduled audits had not taken place. The Quality Manager was unable to explain the reasons for this.

PART 2 - THE NEW PUBLICATION DEVELOPMENT SECTION

Escorted by the Quality Manager, Mr Jones moved into the New Publication Development Section, where he was introduced to Dave, one of the Supervisors. What new publications are you responsible for? he asked.

Dave listed several new publications at different stages of development. Mr Jones then selected a publication nearing completion, a User Handbook for a new communication system, as the example he would like to audit. He started by asking to see the development plan.

Here it is, said Dave taking the plan from the development file and unfolding it on the desk. Each activity right up to completion of the final handbook is shown on this bar chart. Now we are at week number 10 and as you can see we are just about to begin the Final Checking stage.

Mr Jones studied the plan. Yes, he said, Very detailed. I think it covers everything I would expect to see. Do you have any other planning documents, for example, showing who is responsible for each of these activities?

No, replied Dave, I normally just allocate the work depending upon who is available at the time.

Mr Jones asked Dave to explain the requirements for this publication, and Dave replied that it was a fairly standard Handbook design containing text, with some line diagrams and photographs. The information for the Handbook had been provided by the customer. Mr Jones asked if there were any unusual features and Dave replied that there were two large fold-out diagrams at the back of the Handbook.

Did this cause you any problems? asked Mr Jones.

Well it did when Sales first told me about it, because our normal printing company could not do what we wanted. However, I searched around and found a printing company in Belgium that does this type of work and they seem to be making a good job of it, said Dave.

Mr Jones noted the name of the company, SuperPrint, and moved on.

PART 3 - THE DOCUMENT CONTROLLERS OFFICE

Mr Jones made a few notes, then asked Dave about controlling publications and amendments. Why dont we go and talk to Emily, said Dave, She devised our document change control system and is the Document Control Manager.

They went to Emilys office and Dave introduced Mr Jones. Would you please describe your document control system to me, said Mr Jones.

Certainly, said Emily, and she explained the processes by which documents were issued and versions controlled, and referred to the document control procedure DP6.

May I have a look at your procedure DP6? asked Mr Jones.

Yes, said Emily and she went to her bookshelf, got a copy of the procedures and handed them to Mr Jones, who examined procedure number DP6.

Very good, said Mr Jones, and very detailed. Perhaps you could explain your change control system to me in simple terms.

Emily took the procedure from Mr Jones and turned to the forms at the back. Here is our Change Control Form Mr Jones. You see we identify the document to be changed, specify the changes that are to be made, and reference any other items affected. At the bottom of the form are the approval boxes, including one for the customer where applicable.

Mr Jones studied the form then asked to see some change forms that had been completed. Emily went to a filing cabinet and retrieved the appropriate file.

Mr Jones began to look through the completed forms and soon paused and said to Emily, Why is it that someone other than yourself has approved these changes here?

Emily looked at the examples that Mr Jones had seen and explained that they had been approved by her deputy, when she had been out of the office on business. However, Mr Jones pointed out that the procedure DP6 specifically stated that the changes must be approved by the Document Control Manager.

Emily said, Normally that is the case, but surely we must be sensible here, we cant follow our procedures exactly, every time. Mr Jones noted her response and thanked her for her time.

PART 4 - THE PURCHASING DEPARTMENT

Mr Jones asked Jim to escort him to the Purchasing Department where they met Marianne the Buyer. Mr Jones inquired about the selection of suppliers and Marianne showed him the companys List of Approved Suppliers. Mr Jones referred back to his notepad and asked, What about SuperPrint, I dont see them on your List?

Jim prompted Marianne, You remember, that company in Belgium that Dave used for that special printing for the Handbook.

Yes, I remember now, said Marianne, Dave needed to place an order urgently, so we did not have time to carry out our supplier assessment procedure in this case. However, the printing will be checked by our Goods Receiving Department.

Mr Jones looked again at the manuals and asked, Which ones has he checked and which ones did he have problems with?

Im sorry sir, but I do not know the answer to that, replied the inspector. Jack would be able to tell you, but he had to go out this morning to deliver some finished handbooks that were required urgently by one of our customers."

Fortunately, while they were discussing the boxes of manuals, the other inspector, Jack, returned. Mr Jones asked him about the two boxes of manuals. They are for two different customers, said Jack. These in this box are OK, but the ones in the other box must be returned to the printers.

Why? asked Mr Jones, Is the printing not up to your standards?

No, replied Jack, But they are printed double-sided and the customer wants them single-sided.

What did your Purchase Order to the supplier say?, asked Mr Jones.

The instructions were not clear, replied Jack. We normally have these manuals printed double-sided and we did not specify to the printer that in this case they must be single-sided.

Mr Jones thanked Jim and the inspectors, then suggested that they had reached a suitable point to take a break.

They next visited Goods Receiving, where Jim introduced Mr Jones to one of the Receiving Inspectors, who was responsible for checking incoming items.

Mr Jones saw two boxes of manuals on the table and asked what was happening to them. The inspector said, My colleague Jack was checking those earlier and I believe he had some problems.

PART 5 - THE GOODS RECEIVING DEPAR

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