risk based quality management system auditing
DESCRIPTION
All organizations have challenges in their businesses, But these internal and external challenges pose a threat to our goals and risk of their nonfulfillment.TRANSCRIPT
By Safi Qudsi
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.
Realities of Business World
In 1993, FoxMeyer Drugs was the fourth largest distributor of pharmaceuticals in the U.S., worth $5 billion. In an attempt to increase efficiency, FoxMeyer purchased an SAP system and a warehouse automation system it what was supposed to be a $35 million project. By 1996, due to number of issues the company was bankrupt; it was eventually sold to a competitor for a mere $80 million.
FoxMeyer Drugs Bankruptcy
RISK BASED QUALITY MANAGEMENT SYSTEM
AUDITING
Combination of the probability of an event and its consequence (ISO DGUIDE 73)
Definitions of Risk
The chance of something happening that will have an impact upon objectives. It is measured in terms of consequences and likelihood. (AS/NZS 4360)
Risk in Simple Words
Risk = Likelihood X Consequence
Acceptance/Tolerance: With or without planning of contingency.
Reduce likelihood or consequence: By establishing processes and controls
Risk Management
Analysis, evaluation and assessment of risk and its rational control in
helping to promote the objectives and targets of the business
Risk Based Quality Management System Auditing
Auditor typical role was limited to documenting audit findings including non- conformances (if any)
Risk Based Quality Management System Auditing
Risk QMS Auditing = VALUE ADDED AUDIT
Management tool to prioritize the issues accordingly
SCORING TABLE: RISK BASED CONFORMANCE AUDIT & SCORING SYSTEM Quality Management System Conformance
Score Risk Classification
Clause / Sub-Clauses ISO 9001:2008 Standard Requirements
Clause Score
Sub Clause Score H M L
7 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
7.5.2 Validation of processes for production and service
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
• Implementation of planned actions
• Indicators & Measurement.
• Audit
• Plan to reduce Risks identified in audit. Improvement of processes & controls
• Decisions based on analysis and monitoring results.
• Actions taken
ACT PLAN
DO CHECK
Post Audit Activities