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

ISO 9001:2008 Standard Requirements Product Realization

Planning of product realization Customer-related processes (Title)

Conformance Score
Clause Score Sub Clause Score

Risk Classification

7
7.1 7.2

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

Post Audit Activities

Decisions based on analysis and monitoring results. Actions taken Plan to reduce Risks identified in audit. Improvement of processes & controls

ACT

PLAN

CHECK
Indicators & Measurement. Audit

DO
Implementation of planned actions