Risk Based Quality Management System Auditing

4,306 views
3,777 views

Published on

All organizations have challenges in their businesses, But these internal and external challenges pose a threat to our goals and risk of their nonfulfillment.

Published in: Business, Technology
0 Comments
2 Likes
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
4,306
On SlideShare
0
From Embeds
0
Number of Embeds
10
Actions
Shares
0
Downloads
151
Comments
0
Likes
2
Embeds 0
No embeds

No notes for slide

Risk Based Quality Management System Auditing

  1. 1. By Safi Qudsi
  2. 2. Realities of Business World New Satellite Program Major Delays US Govt. faced $3 billion in cost overruns and a three-year delay in new satellite program for Hurricane & severe weather tracking.
  3. 3. Realities of Business World FoxMeyer Drugs BankruptcyIn 1993, FoxMeyer Drugs was thefourth largest distributor ofpharmaceuticals in the U.S., worth $5billion. In an attempt to increaseefficiency, FoxMeyer purchased an SAPsystem and a warehouse automationsystem it what was supposed to be a$35 million project. By 1996, due tonumber of issues the company wasbankrupt; it was eventually sold to acompetitor for a mere $80 million.
  4. 4. RISK BASED QUALITY MANAGEMENT SYSTEM AUDITING
  5. 5. Definitions of RiskCombination of the probability of an event and its consequence(ISO DGUIDE 73)The chance of something happening that will have an impactupon objectives. It is measured in terms of consequences andlikelihood. (AS/NZS 4360)
  6. 6. Risk in Simple WordsRisk = Likelihood X Consequence
  7. 7. Risk ManagementAcceptance/Tolerance: With or without planning of contingency.Reduce likelihood or consequence: By establishing processesand controls Analysis, evaluation and assessment of risk and its rational control in helping to promote the objectives and targets of the business
  8. 8. Risk Based Quality Management System Auditing Auditor typical role was limited to documenting audit findings including non- conformances (if any)
  9. 9. Risk Based Quality Management System Auditing VALUE ADDED Auditing QMS Risk = AUDITManagement tool to prioritize the issues accordingly
  10. 10. SCORING TABLE: RISK BASED CONFORMANCE AUDIT & SCORING SYSTEM Quality Management System Conformance Risk Classification Clause / ScoreSub-Clauses ISO 9001:2008 Standard Requirements Clause Sub Clause Score Score H M L7 Product Realization 7.1 Planning of product realization 7.2 Customer-related processes (Title) 7.2.1 Determination of requirements related to product 7.2.2 Review of the requirements related to the product 7.2.3 Customer communication 7.3 Design and Development (Title) 7.3.1 Design and Development Planning 7.3.2 Design and Development Input 7.3.3 Design and Development Output 7.3.4 Design and Development Review 7.3.5 Design and Development Verification 7.3.6 Design and Development Validation 7.3.7 Design and Development Changes 7.4 Purchasing (Title) 7.4.1 Purchasing Process 7.4.2 Purchasing Information 7.4.3 Validation of Purchase Information 7.5 Product and Service Provision (Title) 7.5.1 Control of product and service provision Validation of processes for production and service 7.5.2 provision Information 7.5.3 Identification and traceability 7.5.4 Customer Property 7.5.5 Preservation of product 7.6 Control of monitoring and measuring equipment
  11. 11. Post Audit Activities• Decisions based • Plan to reduce on analysis and Risks identified monitoring in audit. results. Improvement of• Actions taken processes & controls ACT PLAN CHECK DO• Indicators & • Implementation Measurement. of planned• Audit actions

×