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