ISO 9001 Lead Auditor Training

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.

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