Management Systems

Exercise 1
What does Quality
Mean?
What is Quality?

The ability of a system, process,

or a product to fulfill the
requirements of customers and
other interested parties.
Exercise 2
What is a
Management
System?
What is a Management System?

A management system is a proven

framework for managing and
continually improving your
organization's policies, procedures
and processes.
 Manual (Level One)
The scope of the Management System, including details of, and
any justification for any exclusions
Documented Procedures or reference to them
A description of the sequence and interaction of the processes
included in the Management System

Manual
Procedures, Flow Charts (Level Two)
Procedures as required by the Standard and the Policy ,
plus other documentation to control the processes

Methods of Process
Control/Quality Plans
Work Instructions
Procedures and Flow Charts define-Who does it,? What
is done? When it is done?
Operational Instructions (Level Three)
Instructions to detail how a particular
activity is carried out

Other Support Documentation

(Level Four)
Records
Test Results
Objective evidence to prove that
Support Documentation the system is working
Quality Management
1. Management commitment to the customer and the
company
2. Preventive thinking
3. Confidence
4. Suitable systems
5. Defined objectives
a) Defined roles
b) Defined standards of performance
c) Training and regular review
Process Identification
PDCA Cycle
Process Identification
A process is any activity that transforms inputs into
outputs using resources and being subject to specific
controls.
All activities can be considered as a process.
By identifying and controlling the inputs, providing the
correct resources and applying suitable methods of
control we should achieve the desired output.
Process Identification
INPUTS
✓Materials
✓Data
✓Machines (Resource)
✓Manpower (Resource)
✓Measurement (Control)
✓Methods (Control)
✓Environment (Control)
Process Identification

Primary or main input to a process will be data,

information or instruction to begin.
 Process Identification
Controls

Inputs
Process Outputs

Resources
Process Identification

Primary Process
Process Identification

Primary Process

Secondary Process
Process Identification
Outputs from a process are the results of the
transformation of the inputs.

These may include:

✓Product that is acceptable.
✓Product that is unacceptable.
✓Waste.
 Policy

Objectives

Sales Design Production Inspection Dispatch

Purchasing Stores
 Exercise 3
Popcorn Exercise
Exercise 4
Objectives of
Standard
Interaction of Processes
Design Process

Calibration
Sales
Delivery Contract Review

Product or
Standards Service
Stores Purchasing
API
ISO
Competent Operators

MEASUREMENT DOCUMENTED MANAGEMENT

Process PROCEDURES CONTROLS
Product
Forms Resources
Records Leadership
Evolution of Quality Thinking
➢ The Pyramids
➢ Craftsmen

➢ Industrial Revolution
➢ Mechanisation
➢ War Time Requirements
➢ Statisticians/Gurus

➢ Systems
➢ Empowerment/Delegation
Post World War II Developments
✓ Higher Manufacturing Costs

✓ Profit Erosion

✓ World Wide Competition

✓ New Technologies For Manufacturing

✓ Market Driven Thinking

✓ Survival

= Prevention Not Detection Of Waste

 Quality Assurance Objectives
For the client to have the confidence that he will get:

•What he wants (Quality)

•When he wants it (Delivery)
•At an agreed and accepted price (Cost)

Together with the right relationship

FIRE FIGHTING IS MACHO & EXCITING

SYSTEMS ARE BORING

We spend too much time

fighting yesterday's fires
and not enough on winning
tomorrow's battles

How can we change

this situation ?
 Continual Improvement of the Management System

4
Management
Responsibility
Customers

8
4.3
Measurement, Satisfaction
Customers Organisation
Analysis &
Capability
Improvement

5
Requirements Product Product
Input Realisation Output

Information Flow

Value-adding activities
 Exercise 5
Auditor Competence
Exercise 6
Auditor Personal
Attributes
Internal Audits-
What and Why?
Professional Observant Unbiased

Ethical Discipline

Positive
Analytical Attributes of Impartial
Auditor

Objective Diplomat

Patient Good Listener Inquisitive

 Poor at
preparation and Too rigid Opinionated
planning

Afraid of passing
Jumps to
unpopular
conclusions
judgments
Negative
characteristics
of Auditor
Poor
Argumentative
timekeeping

Bad
Stays in office Easily influenced communicator
 Knowledge & Skills of Auditor – Auditing

To apply audit principles, procedures & techniques.

To plan & organize the work effectively.

To conduct audit within agreed time schedule.

To prioritize & focus on matters of significance.

To collect information through effective interviewing, listening, observing and

reviewing documents, records & data.

To understand appropriateness and consequences of using sampling

techniques for auditing.
Knowledge & Skills of Auditor – Auditing

To verify accuracy of collected information.

To confirm sufficiency and appropriateness of audit evidence to support audit

findings & conclusions.
To assess those factors that can affect the reliability of audit findings &
conclusions.

To use work documents to record audit activities.

To prepare audit reports.

To maintain the confidentiality and security of information.

To communicate effectively, either through personal linguistic skills or through an

interpreter.
 Identify Scope of Audit Team Procedures
Audit Flow of Work

The Audit
Prepare a Plan Time Available

Complete Review

Process Complete Report

Preparation of Checklist Process Based

Time allocated from Plan

Persons to be Interviewed

Undertaking Audit Opening Meeting

Introduce Yourself

Prepare Legible Notes

Deviate from Plan if you suspect problem

Take notes of all objective evidence seen

Thank Auditee

Review Notes Team Review Notes

Identify Problems if any

Write NCR’s

Write Final Report

Closing Meeting Thank Auditee

Identify and Read NCR’s

Accept Comments

If Requested Discuss ways of Solving NCR’s

Report Submit Report to QMR

Scope of the Audit
The audit scope includes an assessment of the Management Systems including:
 Policy and Management commitment

 Leadership and employee involvement

 Awareness and legal requirements

 Objectives

 Organisation and responsibility

 Training and education

 Communication
 Management System documentation

 Operational control

 Monitoring, assessment and measurement

 Review, improvement and recognition

Audit Plans
 Audit Objectives and Scope
 Audit Criteria
 Focus/Risk Areas
 Organisational/Functional Units, Processes to be Audited
 Sequence of Events
 Key Individuals that may be required for Interview
 Reference Documents
 Identity of Audit Team Members
 Date of Audit
The Audit Process
Communication

 An Audit consists of a number of interviews.

 Every interview consists of the transfer of
information between two people.

Who? What? Why? When?

How?
Where? Show me
Audit Checklist

To assist in
To assist with
keeping the audit
time management
on track

Purpose

To provide a
To provide structured
evidence of a full approach to the
system audit audit
The Audit Checklist

Process Based Audit Checklist

✓ Should follow a logical process flow
✓ Should identify all inputs into the
process
The Audit Checklist

 Can be restrictive
 Could miss something if followed rigorously
End of Day One
 Exercise 7
Initiating the Audit
 Exercise 8
List of Documents
Exercise 9
Audit Plan
 Exercise 10
Preparing a Checklist
Audit Techniques
Process Documents

Ask for outline of process

Show me

Check Process Records

Collecting & Verifying Information

INTERVIEW EXAMINE
PEOPLE DOCUMENTS

OBJECTIVE
EVIDENCE

OBSERVE
ACTIVITIES &
CONDITIONS
Opening Interview

• Be on time
• Introduce yourself
• Ensure appropriateness of time
• Explain the purpose of the discussion and
how the information gathered will be used-
Explain that you will be taking notes. Assure
confidentiality
• Strive to build the desired sense of comfort
and confidence
Conducting Interview
 Request an interview of the interviewee’s job and
applicable responsibilities
 Watch your language-Clarify acronyms
 Start with some general questions, then gather more
detailed information
 Resolve ambiguities through constructive probing
 Do not run over time without checking
 Provide feedback as appropriate
Conducting Interview
Don’t rush the
Don’t get into Don’t force a interview
debates meeting

Don’t use a Be wary of using

Don’t amplify tape recorder sarcasm/humour
criticism given

Don’t communicate
Don’t jump to incomplete or Don’t show
conclusions unsubstantial your reactions
findings/conclusions
The Audit Process
Communication

 Body Language
 Facial Expression
 Look of Horror
 Sharp intake of breath
The Audit Process

DO NOT GIVE OPINIONS

You cannot tell an organisation

how to run their business
 Collecting Information

Interviewing techniques and active listening

▪ Techniques of further enquiry

▪ Active listening

Handling Resistance

Forms of resistance (some examples)

• Digression from topic, monosyllable answers or none at all, lack of
concentration, shortage of time, verbal attacks and aggressiveness
Documenting Interview
A Two Step Process

Take Notes

Review immediately afterwards

Techniques for Recording Information
 Write while conducting the audit
 Start each new topic on a new page
 Clearly label each working paper page
 Keep entries factual and legible
 Write clearly in an understandable style
 Include photocopies of selected documents
 Maintain an exhibit list
 Highlight “to do” items and findings
 Develop and use standard “tick marks”
Tips for Effective Note Taking
 Never hide the fact you are taking notes
 Offer the interviewee the opportunity to view notes (if
necessary)
 Keep notepad within easy reach
 Take notes about facts that are relevant to the audit
scope
 Put the interviewees words into quotation marks to
distinguish them
Gathering Audit Evidence
There are several tasks in formulating a sound verification
strategy

Evaluate what needs to be done

Determine the depth and rigor of review

Select the types of evidence needed and the methods to gather them

Compare practices against requirements

Document results
Gathering Evidence
In general there are 4 types of evidence that can
be gathered during an audit

Documentary
Physical Evidence Evidence

Circumstantial
Testimonial Evidence Evidence
End of Day 2
Exercise 11
Internal Audit
Report Writing

When writing a nonconformity report it must be:

•Factual
•Value adding

It should not be:

•Trivial
•Of no benefit
Report Writing

Who is going to read the report?

 The management of the auditee

 The auditors’s management
 Colleagues who may have to verify the corrective
action at the next surveillance visit
Gathering Evidence
Upon gathering the information, auditors must
compare facility practices against applicable
Requirements
 Is the facility in compliance with the requirements?
 Is there enough data to evaluate whether systems are
being implemented as designed?
 Are there underlying causes?
Report Writing

A Nonconformity Report should contain

➢ Company name and site

➢ Department or area where the non-conformity was found
➢ Date
➢ Standard and clause number that the non-conformity has been raised
against
➢ Unique reference number
➢ Category of the non-conformance
➢ The Audit evidence
➢ Requirement that the company failed to comply with
➢ Name/signature of Auditor
➢ Name/signature of Auditee
Closing Meeting

Closing Meeting

 Thanks for the hospitality

 Confirm confidentiality
 Present findings
 Announce result (Recommendation)
 Issue documentation
 Conclusion
Closing Meeting
Typically the closing meeting consists of 4 principal phases

Opening the meeting Presenting Audit findings

Discuss
recommendations Closing the meeting
The Audit Process

Verification of Corrective Action must

include an evaluation of the
EFFECTIVENESS of the corrective
action.
HAS THE ROOT CAUSE BEEN
IDENTIFIED AND CORRECTED
Audit Findings
Non Conformity Categorisation

IAF Guidance for the application of ISO 17021 define

a non- conformity as:
The absence of, or the failure to implement and
maintain, one or more Management System
requirements, or a situation which would, on the basis
of available objective evidence, raise significant doubt
as to the quality of what the organization is supplying.
Audit Findings
Non Conformity Categorisation
.

Major Non Conformity

✓ Absence of mandatory documentation
✓ Specified standard requirement not implemented
✓ Product not meeting customer or legal
requirements (CE Marking, Food Safety
Management system,(HACCP))
✓ High number of minor NC against one clause
Audit Findings

Non Conformity Categorisation

.
Minor Non Conformity
 A single lapse against the requirements of the standard or
the company’s documented system.
Audit Findings

Observations/Opportunity for
Improvement
 A process for adding value to the management system.
 Identifying potential weaknesses in the system.
 Exercise 12
Preparation of Report
Findings
Exercise 13
Presentation of
Auditor Findings