Case Studies - ISO 9001-2015 [PDF]

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ISO 9001: 2015 INTERNAL AUDIT TRAINING CASE STUDIES Corrective Actions Request and Audit Findings Identify any nonconformance for each case below. If it is a nonconformance, then which Clause in the ISO Standard does it not conform to? If you think that it has not enough evidence, state what further actions you will take. No 1

Short Cases Five Purchase Orders were selected at random for sampling. It was noted that one of the supplier, XYZ Sdn Bhd was not selected from Approved Supplier List. XYZ Sdn Bhd was also not evaluated prior to purchase. When asked, the Purchaser said this was a special case where the material was needed urgently and the current supplier cannot supply.

2

The Design Department reflects that their design review was planned and conducted after producing conceptual design, but no records of the review are kept due to confidentiality as claimed by the Design Manager.

3

During an audit at site, it was noted that some incoming of materials were not stored in a covered storage area. When asked, the Store Supervisor claimed that the materials only arrived that morning.

4

The maintenance of the machineries required for realization of product has no record of maintenance.

5

The Store Manager claimed that there is no need to label the materials and their batch number in the store as the store keeper knows how to identify them.

6

During audit, record on calibration of measuring equipment is available but without reference to any standards or methods.

7

Twenty drawings held by a Production Supervisor were selected at random for sampling. It was noted that drawing ABC/001 Revision 0 had pencil markings showing an increase of 5mm to the width of the product. As the change is very minor in nature, it was felt that issuing a new drawing is not necessary. Furthermore, the client has agreed to the changes.

8

Quality policy and objectives displayed at Purchasing Department was of year 2010, the latest dated 2011 at HR and Admin Department.

9

Customer Satisfaction Survey Forms from customers were being kept. Noted that the results from the surveys are good but there is occasionally some feedback of poor services. There was no follow-up on the complaints.

10

A copy of ISO9001:2008 was found in the HR and Admin Department. The department had carried out regular training in ISO documentation and audit for workers.

11

Purchasing Department personnel are not aware of the department objective of Maintenance Department.

12

The Business Development Manager claimed that he didn’t need to record any customer order as he can remember well all the customer orders. Therefore he dismissed the need for a written record for contract review. 1of 2

Comments

ISO 9001: 2015 INTERNAL AUDIT TRAINING CASE STUDIES Corrective Actions Request and Audit Findings Identify any nonconformance for each case below. If it is a nonconformance, then which Clause in the ISO Standard does it not conform to? If you think that it has not enough evidence, state what further actions you will take. No

Short Cases

Comments

13

Data at all departments are collected and analyzed using different methods and techniques. However there was no procedure to guide the personnel on the methods used as all are educated workers.

14

At the factory, data is collected but no analysis on the finished product conformity is carried out as the workers claimed that the data is very clear and straight forward that all data shows that there is no product reject.

15

Latest work instruction for packaging was established, but a worker at store is not following because he claimed that base on his ten years working experience, more defects will be produced if following the new work instruction.

16

A new employed worker is required to go through a competency test and on-thejob training on maintenance. When asked, the worker explained that proper training was provided and he could perform the job well. However, the training was not recorded. When asked, the HR and Admin Manager replied that it is very impractical to record all his worker training as the training is on-going.

17

Management Review Meeting is required to be conducted every 12 months. When asked, the auditee replied that the review was not carried out for the past 18 months due to company expansion and able to produce record on good customer service. In addition, a non-formal management review was carried out verbally 6 months ago.

18

Noted that last internal audit was carried out by auditing own activities. The management claimed that it is unavoidable given the limited number of internal auditors.

19

Project schedule was to define the product characteristics, manpower use and delivery date. Due to too many orders and frequent change of project schedule, the Project Manager feels it is not practical to prepare the updated schedules. Therefore, it was not done.

20

Two items found at outgoing store has no identification of inspection being carried out.

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