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 FoxMeyer Drugs Bankruptcy 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.
RISK BASED QUALITY MANAGEMENT SYSTEM AUDITING
Definitions of Risk
Combination of the probability of an event and its consequence (ISO DGUIDE 73)
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
Risk Management Acceptance/Tolerance: With or without planning of contingency. Reduce likelihood or consequence: By establishing processes and controls
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 nonconformances (if any)
Risk Based Quality Management System Auditing
Auditing
QMS
Risk
=
VALUE ADDED AUDIT
Management tool to prioritize the issues accordingly
SCORING TABLE: RISK BASED CONFORMANCE AUDIT & SCORING SYSTEM Quality Management System Clause / Sub-Clauses
7
ISO 9001:2008 Standard Requirements Product Realization
7.1 7.2
Planning of product realization 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
Conformance Score Clause Score
Sub Clause Score
Risk Classification
H
M
L
Post Audit Activities • Decisions based on analysis and monitoring results. • Actions taken
• Indicators & Measurement. • Audit
• Plan to reduce Risks identified in audit. Improvement of processes & controls
ACT
PLAN
CHECK
DO • Implementation of planned actions