L7 Quality Audits Flashcards
What is a quality audit
A Quality Audit is a planned & documented activity performed in accordance with written procedures & check lists (make sure that all departments are following documented system of recording transactions)
What are the 3 types of audits
Internal-initiated by the company - consultant hired by company
External-carried out by the company to evaluate suppliers
Extrinsic- independent body e.g NSAI
Benefits of audits
- define and track major and minor non conformities
-Builds a manufacturing intelligence knowledge base capable of tracking + predicting quality performance
-Maintain high health and safety
-providing improvement recommendations
-customer based metrics and key performance indicators (KPI)
Depth of the audit (4)
- Systems Audit - systems of company are in conformity (random checks of quality manual)
2.Compliance audit - Detailed checks on how system operates (makes sure quality manual is being followed)
3.Full audit - Covers every aspect of a quality plan
- Partial audit - covers only some aspects
Audit plan (pre audit procedure)
- Audit schedule - audits to be performed and objectives
- Notification - Organisation must be notified in advance
3.Review Documentation - Audit team must review SOPs, quality manual etc..
4.Develop checklist - checklist of items to be covered - Agree audit program - Who will conduct audit. time of start, finish etc.
Performing audit
- Entry interview - audit team meets personnel involved, introduce audit team, discover break times, check quality manual, agree on escorts, fix time for exit interview.
2.Info gathering - Material, People, Equipment, Methods.
- Exit interview - Discuss the results w/ management, verbal report of findings by audit team, auditor describes corrective actions.
- Findings - Summary, Corrective action, observations, audit report detail(checklist)
- Follow up - Auditor explains how corrective actions are to be handled, schedule a re-audit of deficient areas.
