This document discusses different types of quality audits, including adequacy audits done every 1-3 years to check suitability, and compliance audits done more frequently to check documented systems. It describes product, process, internal, supplier/vendor, and third party audits. Internal audits can be first, second, or third party. Third party audits result in ISO certification that is valid for 3 years. Non-conformities identified during audits are typically minor or major, and result in a non-conformance report and corrective action. While audits are usually not a surprise, the specific samples examined may be unexpected.
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Quality Audit
This document discusses different types of quality audits, including adequacy audits done every 1-3 years to check suitability, and compliance audits done more frequently to check documented systems. It describes product, process, internal, supplier/vendor, and third party audits. Internal audits can be first, second, or third party. Third party audits result in ISO certification that is valid for 3 years. Non-conformities identified during audits are typically minor or major, and result in a non-conformance report and corrective action. While audits are usually not a surprise, the specific samples examined may be unexpected.
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QUALITY AUDIT
NOT A HIDE-’N’-SEEK GAME
‘Fact finding’ practice To verify compliance Unlike inspection which is a ‘fault finding’ Types of Audit Adequacy Done at intervals of 1-3 years Revisit procedures and processes to check suitability with environment Revisit business processes Look for improvement in process Gaps called “Areas for improvement” Compliance More frequently- quarter/semester Documented systems available People drawn from outside the system Product Audit May be contractually agreed with the customer. The customer sometimes employs an external agency for doing so. If not, done with internal auditors Planned to be performed at the final stage of inspection Features: Unannounced, Reinspected PROCESS AUDIT – done by Inspectors /Engineers INTERNAL AUDIT: First party audit – By your internal system Second party audit a) Supplier audit b) Customers audit product Third party audit Consultant/agency- Normally certification is accompanied eg: ISO 9000 – valid for 3 years subject to success of 5 surveillance audits. If there is non conformance you are given 3 months time for corrective action. If there is non conformance in process, then it is stated by auditors that it should be in place before the next surveillance. VENDOR/SUPPLIER AUDIT
Two stages i) Induction Audit – Pre- announced ii) Performance Monitoring Audit – Surprise/ announced NON-CONFORMITY
MAJOR – System documented but practice
not done MINOR - Deviation from sytem eg: 1) Procurement from approved source not done - Score is 9 out of 10 2) Obsolete documents found in the work place Minor non conformances are realized as a symptom and more samples are taken. If symptoms do not get repeated, then they are dismissed as “sporadic” Action warranted if symptoms repeated Non Conformance Report (NCR) given to process owners.
Contains particulars of:
- What is the Non conformance
- To what does it attribute to - Explain why it is an NC “AUDIT IS USUALLY NOT A SURPRISE EVENT.”
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