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QS9000 3rd edition, 4.17

R

ROSEMUND J.

#1
There are few requirements under 4.17.1, where:

1. the internal audit should cover all shift
2. Audit schedule updated annually, and

3. When internal/external nonconformance or customer complaints occur, the planned audit
frequency should be increased.

Please see below situation:

1) I believe this is only applicable to manufacturing related elements, such as 4.9,
4.12...etc. In my factory, I have QA specialist/operators doing shiftly audit focusing on product and process conformances. I also have interbal quality system auditor (trained and certified by consultants) focusing on systemic issue. Is this meet the intent?

2. What does it mean "updated annualy? My consultant told me, there should be a planned audit schedule and the schedule can only be changed annually. I have to follow the schedule consistantly without fail except there is special event. This is not feasible as a lot of activities, customer visit/audit, corperate audit..etc happening. We have to change the schedule to maximize our resources. Could anyone give me some suggestion, comment?

3. I do not know how to meet this. I believe every company has internal/external
non-conformance, if everytime we need to increase the frequency, I will be in trouble. Please advice.


Thanks.
 
B

Batman

#2
Hi Rosemund

1. Internal audits should "verify whether quality activities and the related results comply with planned arrangements and to determine the effectiveness of the quality system." It is difficult to restrict this to only manufacturing activity.

You seem to have folks involved in auditing, that's good. But the personnel should be independent of the activity that is being audited. We use operators but in different departments than they work.

2. Typically an audit schedule is prepared up to a year in advance. After accumulating findings and any other nonconformances over that time you must review those instances and decide if and where and what to adjust in your next audit schedule. If you determine that there is not enough documented reason to increase the frequency, you should have a record of that meeting and the decisions made.
Satisfying the customer - a visit for instance - should take precedence over a scheduled audit, if it must. I think an isolated instance or two would not offend your registrar, or your management. I would hope that if this becomes an issue, that management allocates resources to overcome this (QS 4.1.2.2)

3. Unfortunately it is a requirement, somewhat as a follow-up to corrective actions from findings and internal and external nonconformances, to increase your audits. Consider the reasoning - you have what you think is a good system, but the customer found a problem. Your system needs improvement, and auditing is one method of verifying this.

Hope this helps.
 


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