Q& A

ISO 9001:2008

ISO 9001 Auditor Training - Typical multiple choice questions worth one mark each. Only circle one answer for each question.

1 Planning for a QMS audit requires: a. establishing an audit schedule. b. determining the scope of the audit. c. considering prior audit results. d. reviewing quality system documentation. e. all of the above.

2 The information sought by a QMS auditor during an audit is: a. Senior management commitment to the quality system b. A list of nonconformities against the ISO 9001 standard c. Conformity to specified audit criteria d. Product shipped met customer requirements e. All of the above

3 An audit plan is: a. a facilities layout b. a description of the activities and arrangements for an audit c. a checklist of questions to be asked during an audit d. a) and b) e. b) and c)

4 The main purpose of the program of scheduled QMS audits is to: a. resolve the problems in production. b. reduce in process verification. c. verify the effective implementation of the quality management system. d. all of the above. e. b) and c).

5 The “degree to which a set of inherent characteristics fulfills requirements” is the definition of: a. quality assurance. b. quality control. c. quality. d. all of the above. e. none of the above. 6 The management representative must: a. perform all tasks relating to the quality management system b. chair the management review meetings c. be a member of the organization’s own management d. b) and c) e. none of the above.

7 The audit team members should meet frequently to exchange information during the audit in order to: a. ensure that all of the audit objectives are met. b. ensure that as many nonconformities as possible are found. c. evaluate the performance of each member of the team. d. all of the above. e. none of the above.

8 Internal audits are used to verify that: a. products conform to technical specifications. b. the quality management system is effectively implemented. c. no nonconformities exist in the quality management system. d. all of the above. e. none of the above.

9 The frequency of third QMS party audits is determined by: a. the Registrar and auditee b. the Registrar and customer c. the client d. only a) and b) e. only b) and c)

10 The primary purpose of an opening meeting is to a. develop the plan for the audit. b. introduce the audit team and confirm arrangements for conducting the audit. c. determine what auditor and auditee resources are required to undertake the audit. d. all of the above. e. none of the above.

11 The evidence of a nonconformity identified during an audit should be a. recorded in the auditor’s notes or checklist. b. acknowledged by the management of the audited company. c. capable of being checked later. d. all of the above. e. none of the above.

12 The output from management reviews of a QMS based on ISO 9001 should lead to decisions or actions related to: a. Improvement in the effectiveness of the quality management system b. Improvement of product related to customer requirements c. Increased efficiency in use of resources d. Only a) and c) e. Only a) and b)

13 The number of auditors assigned to an audit and their related experience and qualifications should be dependent on: a. the scope of the audit.

b. the time available to perform the audit. c. the purpose of the audit. d. all of the above. e. none of the above.

14 Opportunities to take preventive action may be found by analyzing: a) Records of internal and external audits b) Market and service feedback c) Product nonconformities and returns d) All of the above e) Only a) and b)

15 As per ISO 9001 requirements, the purpose of QMS records is to provide objective evidence of: a) Product conformance b) Process capability and quality system conformance and effectiveness c) Conformance with environmental, health and safety requirements d) All of the above e) Only a) and b)

O 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 evaluating 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.

Exam Exercise 4 - Short Essay Questions

ISO 9001 Lead Auditor Training - Typical short essay type questions are worth 5 marks each. Your response should cover a breadth of several points as opposed to going into depth on one or two points. (Tip: Provide bullet point answers covering 5-10 separate points)

1 Explain the characteristics of (and differences between) a first party, second party, and third party QMS audit.

2 A complete audit of an organization's QMS consists of two distinct stages. Briefly describe each of these stages.

3 An auditor is conducting a third party QMS audit and the guide that has been appointed to accompany him is called away by his supervisor. After five minutes, the guide has not returned. What should the auditor do? What should the auditor not do?

4 Identify five clauses where planning of QMS activities is required by ISO 9001 and briefly explain each planning activity.

5 State the typical objective evidence that could be gathered in order to verify conformity with the requirements of clause 7.6 of the ISO 9001 Standard. Your answer should contain at least five specific examples in order to illustrate your understanding.

6 An experienced auditor has been instructed to carry out a QMS audit of a potential supplier. From initial contacts with the supplier, it is learned that a formal documented QMS does not exist. List five steps the auditor could take in planning for such an audit.

7 An auditor may experience delaying tactics while conducting an audit. Give two examples of such tactics and describe three ways in which the auditor could deal with these situations.

8 State four advantages and one disadvantage of using checklists to perform a QMS audit.

9 At the closing meeting, the quality management representative (QMR) of the organization audited informs the auditor that they have now written a procedure to correct a serious non-conformity that the Registrar auditor found on the first day of a two-day external audit. The QMR proposes that the auditor examine the procedure during the meeting and then withdraw the nonconformity report. How should the auditor respond?

10 List and briefly explain five different ways in which an auditor obtains objective evidence while performing a QMS audit.

11 Explain the purpose and benefits of a preliminary visit to a company by the audit team leader prior to a QMS audit.

12 Arriving for the closing meeting, at the conclusion of an audit in which numerous nonconformities have been recorded, the auditor is told by the quality management representative that none of the senior managers who were contacted are available to attend. What should the auditor do?

13 While in the warehouse during a third party QMS audit, the guide gets into a heated argument with the warehouse clerk over the absence of inspection status labels on skids of paint pails being stored on the racks. The warehouse clerk claims labeling is not necessary because the racks are a designated area for the paint pails to be kept until inspected and approved by the inspection department. The guide turns to the auditor and asks for support. How should a third party auditor respond?

14 At the opening meeting of a third party QMS audit, the management representative (QMR) of the audited company informs the auditor that a recent internal audit has disclosed numerous deficiencies in control of calibration. Corrective action is being planned. The QMR proposes the audit of the calibration department be deleted from the audit plan. How should the auditor respond?

15 What objective evidence could be available in order to verify nonconformity with the requirements of clause 7.4 of the ISO 9001 Standard?

SO 9001 Lead Auditor Training - Typical long essay type questions are worth 10 marks each. Your response should cover some depth on the subject matter. (Tip: Provide a combination of narrative and bullet points covering around 200-250 words in your response)

1 Describe the responsibilities of a QMS auditor who is a member of a third party QMS audit team.

2 An audit is being planned on an organization that carries out purchasing activities and verification of purchased products. Write an audit checklist of eight key controls that an auditor should cover during an audit of those activities. State the relevant clauses of ISO 9001.

(Hint: For full credit, students should use a process based approach and address at least three different clauses of ISO 9001)

3 Describe the typical levels of QMS documentation. What objective evidence should be looked at to verify that QMS documents are being controlled in conformity with clause 4.2.3 of ISO 9001?

4 List and explain the agenda items that a third-party QMS audit team leader should cover during the closing meeting with the management of the organization being audited.

5 a) Clearly explain the steps that an auditee organization may take in responding with corrective actions to nonconformities raised during a third party QMS audit. 5 b) What follow-up options are available to a third-party QMS auditor, to ensure that the auditee organization has effectively carried out the corrective actions?

6 An audit is being planned on a company engaged in warehousing and distribution activities. Items are moved from the receiving area and stored on racks in the warehouse using forklift trucks, until required for shipment. Write an audit checklist of eight key controls that an auditor should cover during an audit of those activities. State the relevant clauses of ISO 9001.

(Hint: For full credit, use a process based approach and address at least three different clauses of ISO 9001)

7 List and explain the agenda items that a third party QMS audit team leader should cover during the opening meeting with the management of the organization being audited.

8 An audit is being planned for a company that receives customer’s sales orders for products by telephone, fax, and e-mail. The products are shipped directly to the customer from a warehouse using the company’s own trucks. Write an audit checklist of eight key controls that an auditor should cover during an audit of those activities. State the relevant clauses of ISO 9001.

(For full credit, students should use a process based approach and address at least three different clauses of ISO 9001)

9 What are the benefits of implementing a QMS that meets the requirements of ISO 9001? Identify and describe three clauses of ISO 9001 that provide opportunities to improve the quality system and overall business performance.

Exam Exercise 7 - Writing nonconformities

The following statements were presented to management by a third party audit team at the conclusion of the QMS audit. These statements are all nonconformities that have been poorly written by the auditors that found them.

Requirement 1: Based on what you have learned in this ISO 9001 Lead Auditor Training course, on collecting audit evidence and reporting of nonconformity findings, identify why these statements are poorly written and how you would have written them.

Requirement 2: Identify the ISO 9001 clause number that you think would be the most appropriate selection for the stated nonconformity.

1. A copy of a machine set-up instruction/checklist MSU 1201 on how to set up machine #1201 was marked “not under change control”. 2. In the Storage Room, stocks of food additives were found to be contaminated by fumes from extraction ducts that were not airtight. 3. A written instruction requires the involvement of the quality department when labels need to be restored to course binders that have lost their labels. The temporary personnel who said they restored labels were unaware of the approved instruction and the method they described did not comply with it anyway. 4. No internal audit had been carried out on Human Resources, Maintenance, Sales Order Entry, Information Technology. The Quality Manual (clause 4.2 states that audits will be carried out on all departments on a six-month basis as a minimum. 5. The work instructions for field service contracts JLL-0295/C, DCG-2596/A, and FG-18423/X did not communicate special requirements due to lack of space on the work instruction form. The sales entry order clerk had been given no guidance as to how to deal with such a contingency. 6. Therma-Glo (a material critical to product quality) does not have a purchase specification and there is no procedure for quality verification of incoming material. 7. The jig fixture used for checking stamped plates on the production lines was badly maintained. Guide pins were unstable causing misalignment and the reflection surface for underside inspection was very dirty. 8. Although amendments to sales orders are recorded on receipt in Sales, there is no method to ensure the changes are implemented throughout the system. 9. It is a requirement that test containers used for the Avery weigh scale are approved and issued by the laboratory. There were test containers being used on the filling lines that had not been so approved. 10. On the drum filling line, the requirement of 50 drums per hour to be inspected was not being met. An average of 10 drums per hour was inspected between 3 pm and 12 midnight. 11. Gel Sealant was being held longer than the 5 minutes allowed at pouring temperature and was not filtered before being applied on the line. 12. The patient medical records for recent tests showed occasional hand-written alerations. These lacked an approving signature or date.