Process Auditing

Chapter 4 Process Auditing

Chapter 4

What is a Process?

Procedure*
Specified way to carry out an activity or a processMay be documented or not

Input

Process
Set of interrelated or interacting activities

Output Product
Result of the process

Monitoring and Measurement of Effectiveness

This is the definition of Procedure given in ISO 9000-2000 This is not necessarily one of the 6 documented procedures required by ISO 9000-2000

Chapter 4

Required Documents

The 6 documented procedures

Management Review 4.2.2, 5.1 Control of Documents 4.2.3 Internal Audit 8.2.2 Control of non performing product 8.3 Corrective Action 8.5.2 Preventative Action 8.5.3

Chapter 4

Comparison of 1994 with 2000

Procedures:
Are driven by completion of a task Are implemented Are steps completed by different people in different departments with different objectives Are discontinuous Focus on satisfying the rules Define the sequence of steps to execute a task May be used to process information

Chapter 4

Comparison of 1994 with 2000

Processes:
Are driven by achievement of a desired result Are operated Stages are completed by different people within the organization Flow to a conclusion Focus on satisfying interested parties Transform inputs into outputs through the use resources Information is processed through the use of a procedure Behave- the are dynamic

Chapter 4

Process Methodology

All Processes have 6 characteristics that need to be verified:

Process has an owner Process is defined Process is documented (if necessary), and understood Process linkages are established Process is monitored and measurable Process has records maintained

Chapter 4

Process Methodology

Processes have 4 questions:

With what? (materials/equipment) With who? (qualifications, skills, training, experience, etc.) With what key criteria? (measurable objectives, assessment) How? (methods and techniques)

Chapter 4

COPS MOPS - SOPS

COPS
MOPS SOPS

Chapter 4

Customer Oriented Processes

Processes that begin with a customer requirement, specification or implied contract and end with a fulfillment of the requirement:
Market Analysis/Customer Requirements Bid/Tender Order Product Design Product Verification COPS Delivery Payment Warranty Service

Chapter 4

Support Oriented Processes

Any Process whose input, output and transformation activities are established and maintained by an organization to comply with requirements or specifications.
Documents/Records Control Inspection and Testing Equipment Calibration Training Human Resources Purchasing IT

SOPS

Chapter 4

Management Oriented Processes

Those Processes/activities necessary for Management to comply with requirements of the standard
Management Review Corporate Objectives Internal Audit Corrective Action Preventative Action Communication Customer Satisfaction

MOPS

Chapter 4

Process Turtle

4. With What? _____ __________________ __________________

5. With Who?_____ ________________

3. Inputs

1.Process_______ ________________ ________________

2. Outputs

7. How Effective? ___________________ ___________________

6. How? _________ _________________ _________________

Chapter 4

Processes linked to the Standard Model

Continual Improvement of the quality management system

Management Responsibility

Customer Requirements

Resource Management

Measurement, Analysis, and Improvement

Customer Satisfaction

Product Realization

Product

Chapter 4

Process Workshop

Work Shop Exercise:

1. Each team to develop process turtle for typical

COP, SOP or MOP

2. Spokes Person present team ideas 3. Time: 1/2 Hour

Chapter 4

Process Workshop

Work Shop# 2
Team to review graphs/charts indicating performance of a particular process. a. Analyze Graphs b. Determine standard requirements that may have prevented the poor performance. c. Categorize the requirements under the appropriate legs of the turtle 1 hour for team discussion

Close of Day 1

Review Lessons Learned today? What to expect for tomorrow!

Process Auditing

Day 2

Agenda Day 2

Day 2
Chapter 5 Audit Performance Break Team Workshop Feedback Audit Reporting Chapter 6 Nonconformance Reporting Lunch Workshop Non Conformance Chapter 7 Top Management Break Top Management Workshop Chapter 8 Session Wrap-up

Process Auditing

Chapter 5 Audit Performance

Chapter 5

Audit Planning

Manual Review
Standard States: 4.1, 4.2.2
The Organization shall establish and maintain a quality manual that includes:
A. The Scope of Quality Management System
B. Documented procedures established for the QMS C. A description of the interaction between the processes and the QMS

Chapter 5

Audit Planning

ISO 9001-2000 Standard Interpretation

Processes of the organization need to be identified, per 4.1.a
Graphical representations such as process maps/flowcharts are perhaps the most easily understandable method of describing interaction between processes (but not required) Interactions may be described by way of references and/or cross reference

Chapter 5

Audit Planning

Audit Planning Schedule

Complete Applicability Matrix Audit Schedule developed from the results of the Quality manual review and the completion of the applicability matrix Schedule based on process in the organization Schedule shall be based on status and importance of processes Schedule is NOT to be based on the clauses of the standard!

Chapter 5

Audit Planning

Workshop - Manual Review

Review of Zap Electronics Quality Manual Conclude on the likelihood of a successful site audit and overall conclusions on the manual, Does manual meet the intent of the standard? Complete ISO 9001:2000 Process Matrix Develop a process based audit schedule

Chapter 5

Audit Planning

Audit Reporting
Sample Report Format Process Oriented Intended to be Value Add for the organization Auditor notes and records aligned with processes Process Applicability Matrix should be part of report

Review of new Audit Report - Q&A

Process Auditing

Chapter 6 Nonconformance

Chapter 6

Nonconformity

Nonconformity
ISO 9001:2000 Standard states:
The non-fulfillment of a requirement

Audit Findings
Nonconformities are to be recorded and supported by evidence
Major Systematic failure within entire organization and/or failure to address an entire clause or sub clause of the standard within a process Minor Isolated lapse of a clause or sub clause of the standard detected within a process

Chapter 6

Nonconformity

Nonconformity Reports
Clear and precise Concise and accurate Comprehensive Describe the problem Explain the requirement Reference the evidence Completed on the appropriate forms Actions Taken without undue delay

Chapter 6

Nonconformity

Workshop -Nonconformity Reports

Determine for each incident if there is enough evidence, based on the information given, to identify a nonconformance
If you feel there is enough evidence complete the top portion of the form If not enough evidence, as the auditor, what actions do you take?

Process Auditing

Chapter 7 Top Management

Chapter 7

Top Management

Auditing Top Management

Chapter 7 Conversation Threads:

Please explain the Management Structure Explain how Quality policy was developed Explain how objectives were developed and communicated How are objectives linked to quality policy How has management identified objectives at all levels How does management ensure that policy and objectives are understood at all levels

Top Management

Chapter 7

Top Management

Avoid:
Quoting Specific Requirements of the Standard Requesting specific evidence Ask questions that are related to very specific areas of business Taking too much time

Chapter 7 Remember:
We are trying to gather information that will help us understand the level of top Management commitment The true test of the answers to the conversation threads will be when we talk to the people in the organization Top Management puts their pants on the same way you do, One leg at a Time!

Top Management

Process Auditing

Chapter 8 Session Wrap-up

Chapter 8

Wrap-up Session

What are some of the concepts youve learned that have added to your level of knowledge from this training?