ISO 9001 Lead Auditor Training

Exam Exercise 6 - Evaluation Of Audit Situations

ISO 9001 Lead Auditor Training - During the course of ISO 9001 QMS audits of various organizations, auditors will run into a variety of situations where they will have to determine whether they have sufficient objective evidence of a nonconformity or not, and report their findings. Each of the situation questions listed below is worth 10 marks on the exam. Practise evaluationg these situations to sharpen your auditing skills.

Based on the information given, if you think the situation represents a nonconformity, then complete a nonconformity form that includes the following information: Situation #; area/process being audited; applicable ISO 9001 clause #; whether the nonconformity is major or minor; a clear description of the specific requirement that the situation is nonconforming against; a clear description (finding) of the nonconformity itself, supported by relevant objective evidence.

OR, based on the information given, if you do not think there is a nonconformity, then clearly state your reason(s), and also provide at least 3 further actions you would take to gather additional evidence of conformity or nonconformity (had you been there performing the audit).

Here is a list of some typical situations for you to practise on.

Situation number 1 
During a Stage One - QMS document review, the auditor notes that a company procedure, QAP 05, revision 3, states that when testing raw material RH 2005 for acceptance, the results will be unreliable if the test samples are taken closer than 20 inches apart on the material. In the Receiving Inspection Lab, the auditor notices an inspector carrying out an acceptance test on material RH 2005. The auditor asks the inspector how the sample position on the material is selected. The inspector replies that they are taken 6 inches apart to avoid wasting material. Upon inquiring about his procedure, the auditor was shown the inspector’s copy of QAP 05, revision 2 on a shelf near the inspector’s desk.

Situation number 2 
In the ABC Inc, Medical Center, which is within the scope of QMS registration, the auditor asks to see the work instructions for a nurse. There are no written instructions on how to administer first aid treatment for cuts and minor injuries, nor are there any written instructions of what to do if a patient's heart stops beating. The guide says that ABC employs three nurses all of whom have been professionally trained as Registered Nurses and have certificates of competence issued by a recognized university teaching hospital.

Situation number 3 
In the Wardens office, the auditor notices a binder entitled “Penal Institution Administration Practices” on  the bookshelf and asked whether these contained departmental procedures for the penitentiary. The warden confirms that the file does contain these procedures, but adds hesitantly that this document is now on computer available to all supervisors at their terminals for many of their activities. After selecting A2, B5, C3 and D4 from the binder, the auditor notes that they are all at revision 1. The auditor asks the Warden to show them on the terminal. The computer version of B5, C3 and D4 are at revision 3. The other sections are at revision 1.

Situation number 4
In the maintenance department, the auditor notes that contrary to the company’s work instruction, TDWI 05 issue 3, which is clearly displayed at all work stations, three of the ten people in the department are not wearing the company issued safety glasses when operating machining equipment.

Situation number 5
In the purchasing department, the auditor notes that the staff are placing orders over the phone with suppliers using a computerized purchasing system. On inquiry, the auditor is told that the staff has been fully trained and the database holds details of all supplier contract specifications and, therefore, there is no need for an independent review of individual orders.

Situation number 6
In the quality manager’s office, the auditor asks to see the schedule for internal audits. This schedule shows that each of the eight QMS processes are audited every six months. The auditor asks the quality manager how the frequency of audits was decided. The manager says that when the system was set up three years ago, 6-month intervals were specified for all processes. The company has kept to this original schedule. The auditor asks to see the file containing corrective action requests (CARs). It lists 85 CARs for the past two rounds of internal audits. Of these, 65 CARs are in the production department and the remainder are spread evenly over five other departments. Two departments received no CARs.

Situation number 7
In the shipping area, the auditor stops to look at six finished products, serial numbers X245 to X250, in individual cardboard cartons. The auditor asked the shipper why the items are packed in corrugated cardboard instead of plastic containers as required by packaging work instruction PWI 6, revision 2. The shipper replied that the shipping supervisor had instructed them to use corrugated cardboard when they ran out of plastic containers three weeks ago.

Situation number 8
During the audit of the tool and die department of a major automotive component manufacturer, the auditor asked to see the work instructions for the turning and milling operations. The toolroom foreman indicated that there were no work instructions for these operations other than a router indicating operation name and equipment to be used. He added that these operations were performed by operators that were highly experienced and certified in their respective trades.

Situation number 9
In the design department, the auditor sees three incomplete products on a desk. The design manager explains that these products came from the production department because of problems in manufacture. There is no identification on any of the three incomplete products or any indication of their inspection status. Further investigation by the auditor was unable to locate any inspection records relating to the incomplete products.  

Situation number 10
In the engineering department, the auditor is shown procedure SOP 7.3 which requires that all engineering drawings must be signed off by the draftsman and the engineering manager prior to issue. He randomly examines a drawing, DWG 1446 rev 3 on the manager’s desk and noticed that the “drawn by” and “approved by” boxes on it were not yet signed off.
Later, in the mail room, he comes across the same drawing with a distribution list attached.

Situation number 11
In the receiving area, the auditor noticed a colour code chart for identifying raw steel bars used to make finished product. Later in the storage area, he noticed a similar chart, but with an additional colour and a control block - C.C.Chart RM 2007 rev 2.  When questioned, the material handler said that the chart is useful for quickly pulling out the right bars.
On examining the document master list, the auditor could not find this chart listed. When asked about this, the quality manager stated that they had moved to a computerized system for identifying steel bars and the colour code charts were no longer relevant.

Situation number 12
In the final assembly area, the auditor observed operators installing laser printer cartridges into desk top printers. When asked about the inspection status of cartridges, the production foreman said that the cartridges had just come in; the materials inspector had called in sick; this was a rush job and delivery commitments must be met.
On further investigation, the auditor found that a shipment of 200 printers from the same order had been picked up by the customer just before noon that day.

Situation number 13
In the production supervisors office, the auditor examined a copy of procedure SOP 7.5 covering production control activities. When comparing against the master copy, she noticed that on page 2, the organization chart had been changed, but not on the master copy.
When asked, the supervisor said that one of her material handlers had left the company and was not replaced. Overall workload was reorganized and the organization chart was amended to reflect this.

Situation number 14
In the Quality Management Representative’s (QMR) office, the auditor flips through the management review minutes for the past year. She noticed the last one was dated 28/11/08; the previous one dated 13/06/08 which made reference to a 22/02/08 review.
When asked about the frequency of such reviews, the QMR said that they were done when senior management is in town and definitely before an external audit. On reviewing 2007 records, the auditor noticed that management reviews were held in May and October. 

ISO 9001 FAQ provides answers to commonly asked questions about the ISO 9000 family of quality management standards.