iso process audit training

Process Auditing

Chapter 1

Course Introduction

Chapter 1 Agenda

Day 1• Chapter 1 Introduction/Welcome• Chapter 2 Customer Satisfaction

– Team Workshop– Break

• Chapter 3 Continual Improvement– Team Workshop

• Lunch• Chapter 4 Process Auditing

– Team Workshop• Feedback

Chapter 1 Agenda

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

Chapter 1 Introduction

Objectives of Training:– The Process Audit workshop is designed to provide auditors with

necessary skills to add value to their organization– Workshop will highlight the need for experienced auditors to audit

top management, understand the continual improvement and the company’s quality management system

– This workshop will:• Provide a “definition” for process auditing• Provide Examples of process audits• Discuss linkages between objectives, process measurement

and continual improvement

Chapter 1 Introduction

Chapter 1 Process Definition

Auditors Clients

Quality ManagementSystem

Consultants

ProcessApproach

Why not doing Process Auditing?

Element ApproachMind set

No clear understanding of Process Approach

Reluctance to Change

Inconsistent KnowledgeOf Process Auditing

Processes and interactionNot Defined

Management SystemNot Process Oriented

Objective not established

for Processes

No “process maps”

Reports and Forms in Element style

Lack of Global Strategy

Not ImplementingProcess Driven systems

Taking Path of Least resistance

No training on Process Audits

No Knowledge of Processes

“boiler Plate” systems

Chapter 1 Auditor Demographics

• BVQI Assumptions– 20% of Auditors are from process

industries, i.e. Chemical Manufacturing, Automotive, and environmental

– 60% of Auditors need basic overview to be able to implement Process Auditing methodology

– 20% of Auditors need training and mentoring if they are to achieve an acceptable level of knowledge

0

10

20

30

40

50

60

Chapter 1 Benefits of Training

• Knowledge of principals and methods of process auditing• Understanding the need for clear knowledge of the

organizations defined processes• Ability to plan, conduct and report a process based audit• Confidence to discuss the “process approach” requirements of

the ISO Management system• Ability to link organizational objectives to Process and sub-

process measurable objectives

Process Auditing

Chapter 2

Customer Satisfaction

Chapter 2 Customer Satisfaction

ISO9001:2000 Clause 8.2.1

• As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined.

• Customer Satisfaction is determined by the organization measuring its customers perception as to whether they have satisfied their customers’ requirements – and may be somewhat subjective or ‘qualitative’ or ‘quantitative’.

• Customer complaints are a common indicator of low customer satisfaction but their absence does not necessarily imply high customer satisfaction.

• Simply capturing customer complaints and product returns will only gauge ‘dis-satisfaction’ – which does not fully meet the intent of the clause and will not satisfy these requirements.

• The organizations management should analyze the implications of the absence or existence of customer complaints.


The organization should identify sources of customer and end-user information, available in written and verbal forms, from internal and external sources and analyze this data for trends, negative and positive. Examples of customer related information include

• Customer and user surveys• Feedback on aspects of product• Customer requirements and contract information• Market needs• Service delivery data• Information relating to competition• Customer disruptions• Special status customer notification related to quality or delivery issues


Examples of sources of information on customer satisfaction include:

• Customer complaints; customer notifications, delivery issues• Communicating directly with customers; questionnaires and surveys• Customer meetings, interviews• Reports from consumer orgs• Reports in various media• Sector and industry studies• Delivered part quality performance• Customer returns• Delivery schedule performance


• Team Exercise: Identify 4 ways of determining Customer Satisfaction

– Keep an open minded approach to auditing customer satisfaction

– Visualize the potential for variety of methodologies

– Discuss potential Pros’ and Con’s of various methods


Process Auditing

Chapter 3

Continual Improvement

Chapter 3 Continual Improvement

• 8.5.1 Continual Improvement The organization shall continually improve the effectiveness of the

quality management system through the use of the:

- quality policy

- quality objectives

- internal audits

- analysis of data

- corrective and preventive actions

- management review

Chapter 3 Continuous vs. Continual Improvement

Time

Improvement

Continuous

Continual

There are two fundamental ways to audit continual improvement process:

a) Breakthrough projects which either lead to a revision and improvement of existing processes or the implementation of new processes; these are usually carried out by cross-functional teams outside routine operations;

b) Small-step ongoing improvement activities conducted within existing processes by people.

(as defined in ISO 9004-2000 Appendix B)


Breakthrough projects usually involve significant redesign of existing processes and should include:

• Definition of objectives and an outline of the improvement project.• Analysis of the existing process (the “as-is” process) and realizing

opportunities for change• Definition and planning of improvement to the process• Implementation of the improvement• Evaluation of the improvement achieved, including the lessons

learned.


Planning

Performing

Measuring

Improving


People in the organization are the best source of ideas for small-step or ongoing process improvement.

• Small-step ongoing process improvement activities should be controlled in order to understand their effect.

• The people in the organization that are involved should be provided with the authority, technical support and necessary resources for the changes associated with the improvement.


Team Exercise: Prepare a presentation on:• How would you conduct an audit of continual improvement at the

following levels of an organization and/or the following personnel. Including audit trails/questions and acceptable evidence of conformance.

1. Top Management

2. Process Owner

3. Operator/ Employee (non-management)• Each team is to record the results of the team discussion

on the flip chart and/or overheads. Each team must prepare the presentation using a small to medium org.


Continual Improvement by either of the methods identified should involve the following:

a) Reason for improvement: a process problem should be identified and an area for improvement selected,

b) Current situation: the effectiveness and efficiency of the existing

process evaluated. c) Analysis: the root causes of the problem should be identified and

verified. d) Identification of the possible solutions: alternative solutions should

be explored..


e) Evaluation of effects: it should then be confirmed that the problem and its root causes have been eliminated

f) Implementation and standardization of the new solution: the old process should be replaced with the improved process

g) Evaluation of the effectiveness and efficiency of the process with the improvement action completed:.

The process for improvement should be repeated on remaining problems, developing objectives and solutions for further process improvement.


Chapter 3 Objectives/Performance

QMS

Process Objectives

Project/Product Objectives

Top Management

Top Management

Process Owners

Quality Policy

Project/Product Team

Planning and Resource Management

Chapter 3 Organization and Process Goals

OTD

Order Process

MaintenanceProcess

PurchasingProcess

WarehouseProcess

ProductionProcess

To achieve OTD you must collectData to understand reason for lateDelivery.

Establish Metrics for Improvement

Engage entire organization in this process

Quality Policy - Defect free product, on time to the customer at reasonable price and continually improving all process in accordance with the ISO 9001-2000 standard.

– Organizational objective – 98% on time to customer promise date– Process objectives established to meet organizational goal

• Order review process – all orders processes within 2 days of receipt• Warehouse process – 100% compliance with FIFO, 18 inventory turns• Maintenance Process – 97% uptime, no past due scheduled items• Purchasing Process – 95% of tier 1 suppliers on time and within window• Production Scheduling – all shop routers completed within 1 day of receipt and

all orders scheduled to be completed 2 days prior to required ship date– Progress towards objectives will be posted monthly and discussed at the quarterly

management review meeting in addition to the bi-weekly production meeting.– A negative trend occurring in 3 consecutive months towards the objective will require a

corrective action.

Chapter 3 Organization and Process Goals

Process Auditing

Chapter 4

Process Auditing

Chapter 4 What is a Process?

Procedure*

ProcessSet of interrelated or interacting activities Product

Result of the process

Input

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

“Specified way to carry out an activity or a “process”-May be documented or not

Output

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 Required Documents

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

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 Comparison of 1994 with 2000

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– Delivery– Payment– Warranty Service

COPS

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

1.Process_______________________________________

4. With What? _________________________________________

5. With Who?_____________________

6. How? ___________________________________________

7. How Effective? ______________________________________

3. Inputs 2. Outputs

Chapter 4 Processes linked to the Standard Model

CustomerRequirements

CustomerSatisfaction

ProductProduct

Realization

Measurement,Analysis, andImprovement

ManagementResponsibility

ResourceManagement

Continual Improvement of thequality management system

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


• 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


• 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!


• 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


• 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


• 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


• 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


• 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


• 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


• 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!

Process Auditing

Chapter 8

Session Wrap-up

Chapter 8 Wrap-up Session

What are some of the concepts you’ve learned that have added to your level of knowledge

from this training?

iso process audit training

Documents

process auditing chapter

auditing customer satisfaction

sources of customer

customer perception

management workshop

customer satisfaction

high customer satisfaction

introductionwelcome