The Auditor from Newtone, Inc. asked to see the documentation and records relative to STEADY BEAT Serial Numbers SB/910000561A, SB/910000387C, and SB/920000423C stating that his company had received complaints of a critical nature concerning these three specific electronic components. The QA manager (designated by the QA manual as the official Management Representative) responded by "Let me check our manual", and then after flipping through it many times finally commented, "Ah, yes. Here it is! The sales department is responsible for and the final repository of all components history and audit records". A phone call was then made by Mr. Quartemote to Mr. U. Bar of Sales and after stating the problem, agreed to meet Quartemote and the auditor in the records room immediately.

On the way over to the records room, Mr. Quartemote gave the Auditor a quick tour of their final "Super Clean Assembly Area". "We aren't able to enter this area but you can see through these windows how clean it is." The Auditor noted that it did indeed appear clean and well controlled except for the large group of people congregated in the center drinking coffee and smoking. Mr. Quarternote remarked after checking his watch that it was break time.

When they arrived at the basement record room, Quarternote remarked how hot and humid it was but passed it off as being due to the steam pipes at the time of the year. Mr. U. Bar was there waiting for them and was busily trying to find the records in question. Mr. U. Bar - explained after the introductions, that the serializing of their units is a very complex numbering system and required cross references to other subassemblies.

The file clerk was busily trying to find all the folders referenced by the three numbers. The stack of documents involved grew by the minute and was explained to the Auditor as being a difficult if not almost impossible task to pull them all together. It was suggested by Quarternote that they proceed to another area of the audit and give the file clerk some time to gather all the required information. The Auditor agreed and suggested they go to Mr. U. Bar's office and review his complaint files. Mr. U. Bar explained that he had a staff meeting scheduled but after making several phone calls was able to reschedule the meeting and they then proceeded to his office.

CASE QUESTION

(a) What is your opinion of the records retained?

(b) Are there any non-compliances with ISO 9001? If so what are they?

(c) Are there any other comments?