slide1
Download
Skip this Video
Download Presentation
Chapter 4 Prevention Versus Detection

Loading in 2 Seconds...

play fullscreen
1 / 62

Chapter 4 Prevention Versus Detection - PowerPoint PPT Presentation


  • 127 Views
  • Uploaded on

Chapter 4 Prevention Versus Detection. Prevention Versus Detection. Benefits of implementation of ISO 9001:. ♦ Enhanced customer satisfaction and loyalty ♦ Reduced quality costs ♦ Increased competitiveness ♦ Improved internal transfer of know how

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Chapter 4 Prevention Versus Detection' - juanita


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
slide1
Chapter 4

Prevention Versus Detection

Prevention Versus Detection

benefits of implementation of iso 9001
Benefits of implementation of ISO 9001:

♦ Enhanced customer satisfaction and loyalty

♦ Reduced quality costs

♦ Increased competitiveness

♦ Improved internal transfer of know how

♦ Improved morale and motivation of staff

Prevention Versus Detection

certification of quality system to iso 9001 as a bonus
Certification of quality system to ISO 9001 as a “bonus”

♦ Tangible proof that the company’s quality system

complies with internationally recognised standard

♦ Avoidance of multiple second party audits.

♦ Marketing edge.

Prevention Versus Detection

why quality costs are so important
Why quality costs are so important

♦ They are often large (10 to 20% of total turnover);

♦ They real volume of quality costs is usually unknown, as fewer than 40%of companies measure them;

♦ Majority of costs (often more than 80%)relate to failure and appraisal activity.

♦ Savings on quality costs may have significant

Prevention Versus Detection

categories of quality costs
Categories of quality costs:
  • Costs of prevention
  • Appraisal costs
  • Failure and rectification costs

Prevention Versus Detection

prevention costs
Prevention costs:
  • Implementation of quality system and subsequent quality planning
  • System verification activities (e.g. quality audits)
  • Management reviews of the system
  • Assessment of subcontractors
  • Training and education
  • Quality improvement programmes

Prevention Versus Detection

appraisal costs
Appraisal costs:
  • Verification of purchased products at subcontractor’s premises
  • Costs of inspection and/or monitoring
  • Cost of maintenance of records

Prevention Versus Detection

failure and rectification costs
Failure and rectification costs:
  • Cost associated with getting things wrong and subsequently putting them right.
  • Costs of corrective actions needed to eliminate the causes of nonconformance or other undesirable situations.

Prevention Versus Detection

establishing the quality costs data base
Establishing the quality costs data base:
  • Identify all quality costs;
  • Segregate the activities into prevention, appraisal, rectification;
  • System to record costs in each category;
  • Suitable accounting system, which would enable allocating the costs to activities and retrieval of data.

Prevention Versus Detection

slide10
Which clauses in ISO 9001 have particularly preventative character?

Prevention Versus Detection

chapter 5
Chapter 5

Quality System

Documentation

Prevention Versus Detection

function and value of system documentation
Function and value of system documentation
  • provide concise set of requirements
  • facilitate consistency of quality activities
  • convey requirements simultaneously to all concerned personnel
  • facilitate effective change control
  • ensure permanence irrespective of personnel change
  • facilitate monitoring activities and quality system audits

Quality System Documentation

slide13
Documents and records(ISO 9000:2000)

Document – information and its support media

Record stating results achieved or providing evidence of activities performed

Quality System Documentation

documents may be established in any form of type of medium iso 9001 2000 clause 4 2 1 note 3
Documents may be established in any form of type of medium (ISO 9001:2000 Clause 4.2.1 Note 3)
  • written texts
  • flow charts
  • drawings or sketches
  • series of sketches, drawings or photographs
  • audio tapes
  • video tapes,
  • master sample, etc.

Quality System Documentation

typical structure of quality system documentation
Typical structure of quality system documentation

Quality

Manual

Procedures

Work Instructions

External

Documents

Forms

Quality System Documentation

general rule
General rule:

The right document must be available at the right time the right place.

Quality System Documentation

purpose of quality manual
Purpose of quality manual
  • Communicate requirements
  • Describing and implementing the quality system
  • Basis for auditing
  • Ensuring continuity
  • Reduce learning curve
  • Demonstrating compliance to the standard
  • Prequalification and contractual purposes
  • Good piece of sales literature

Quality System Documentation

quality manual iso 9000 2000
Quality manual (ISO 9000:2000)

“Document specifying the quality management system of an organisation”

Quality System Documentation

quality manual can iso 10013
Quality manual can (ISO 10013):
  • Be a direct compilation of procedures and other documents
  • Be a grouping or section of quality system documents
  • Be more than one document of level
  • Have a common core with tailored appendices
  • Be a stand alone document of otherwise

Quality System Documentation

typical contents of the quality manual
Typical contents of the quality manual:
  • quality policy
  • Introduction (objectives, scope of the QMS, company’s background)
  • Approval and amendment procedure
  • Explanation of terminology
  • Structure of system documentation
  • Overview of the quality system
  • Annexes

Quality System Documentation

procedures iso 9000 2000 defines procedure as
ProceduresISO 9000:2000 defines procedure as:

“Specified way to carry out an activity or a process”

Procedures may be :

  • Document
  • Informal

Quality System Documentation

procedure needs to answer the following questions
Procedure needs to answer the following questions:
  • What?
  • Why?
  • Who?
  • Where?
  • When?
  • How?

In other words to define the process

Quality System Documentation

chapter 6
Chapter 6

Introduction to Audits

Introduction to Audits

slide24
“systematic, independent and documented process of obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled”

ISO 9000:2000

Introduction to Audits

purpose of the audit
Purpose of the audit
  • to determine conformity
  • to determine the effectiveness
  • to provide opportunity to improve
  • to meet regulatory requirements
  • for certification

Introduction to Audits

reasons to conduct an audit
Reasons to conduct an audit
  • new suppliers
  • regular review of suppliers
  • contractual requirement
  • changes in the system
  • increased orders
  • quality problems

Introduction to Audits

benefits
Benefits
  • Give the management confidence
  • Give customer confidence
  • Observe operational problems
  • Provide opportunity for improvement
  • Provide feedback for corrective and preventive actions

Introduction to Audits

classification of audits
Classification of audits
  • First Party – by an organisation on itself for their own purposes
  • Second party audit – by an interested organisation on another organisation e.g. by customer on the supplier
  • Third party audit – by an independent organisation typically for certification.

Introduction to Audits

initial documentation review adequacy desktop intent audit
Initial documentation review(Adequacy, desktop, intent audit)

?

QMS Manual

Audit Criteria

=

Use checklist

Introduction to Audits

benefits of initial documentation review
Benefits of initial documentation review
  • understand the system
  • assist planning
  • identify need for specialist skills
  • identify problems
  • provide opportunity to fill the gaps
  • assess readiness

Introduction to Audits

conformance or implementation audit
Conformance (or implementation) audit

?

QMS Manual

=

Work practices

Introduction to Audits

understand the difference
Understand the difference

Conformance

with the audit

criteria

Legal

Compliance

Introduction to Audits

types of certification audits
Types of Certification Audits
  • Initial or certification audit
  • Surveillance Audit
  • Re-certification Audit

Introduction to Audits

iso 10011 guidelines for auditing quality systems
ISO 10011 Guidelines for auditing quality systems
  • Part 1: Auditing
  • Part 2: Qualification criteria for quality systems auditors
  • Part 3: Management of audit programmes

Introduction to Audits

iso 10011 1 auditing
Audit objectives

Roles & responsibility

- auditors’

- client’s

- auditee’s

Auditing

Audit documents

Audit completion

Corrective action follow-up

ISO 10011 – 1 Auditing

Introduction to Audits

iso 10011 2 qualification criteria for quality systems auditors
ISO 10011 – 2: Qualification criteria for quality systems auditors
  • Education
  • Training
  • Experience
  • Personal attributes
  • Management capabilities
  • Language
  • Selection of lead auditor

Introduction to Audits

iso 10011 3 management of audit programmes
ISO 10011 – 3: Management of audit programmes
  • Organisation
  • Standards
  • Qualification of staff
  • Monitoring of auditor performance
  • Operational factors
  • Joint audits
  • Code of ethics

Introduction to Audits

iso 19011 guidelines on quality and environmental systems auditing will replace iso 10011
ISO 19011 Guidelines on quality and environmental (systems) auditing (will replace ISO 10011)

1 Scope

2 Normative reference

3 Terms and definitions

4 Fundamentals of auditing

5 Managing an audit programme

6 Auditing activities

7 Qualifications for quality & environmental management systems auditors

Introduction to Audits

fundamentals of auditing general principles
Fundamentals of auditing – General principles
  • Independence – the basis for the understanding & reliability
  • Ethical conduct – the foundation of integrity
  • Fair presentation – reporting truthfully and accurately
  • Evidence – the rational basis for conclusions
  • Due care – reasonable care in all matters

Introduction to Audits

management of audit programmes
Management of audit programmes
  • Objectives and extent of the programme
  • Responsibilities, resources and procedures
  • Implementing the audit programme
  • Monitoring & reviewing an audit programme
  • Records
  • Combined Audits
  • Joint audits
  • Auditor qualifications and training

Introduction to Audits

auditing activities
Auditing activities
  • Initiating the audit
  • Initial document review
  • Preparing for the on-site audit
  • On-site auditing activities
  • Reporting on the audit
  • Audit completion
  • Audit follow-up

Introduction to Audits

qualifications for quality and environmental systems auditors
Personal attributes

Education, training, work and audit experience

Competence

Team leader

Dual qualifications

Evaluation process

CPD

Due professional care

Audit team selection

Language

Qualifications for quality and environmental systems auditors

Introduction to Audits

chapter 7
Chapter 7

Nonconformity

Reports and Corrective Actions

Nonconformity

Reports and Corrective Actions

slide44
Nonconformity: “Nonfulfilment of a requirement”

ISO 9000:2000

Nonconformity

Reports and Corrective Actions

slide45
Be positive
  • Do not view nonconformity in a negative way
  • Uncovering nonconformity presents an opportunity for improvement though corrective action

Nonconformity

Reports and Corrective Actions

slide46
NCR
  • Report as per client’s procedure
  • No set rules
  • Commonly specific form
  • Some organisations require descriptive record within overall audit report

Nonconformity

Reports and Corrective Actions

slide47
Example of form

Nonconformity

Reports and Corrective Actions

nonconformity report
Nonconformity Report
  • Clear and precise
  • Concise and accurate
  • Comprehensive
  • Describe problem
  • Explain the requirement
  • Reference the evidence

Nonconformity

Reports and Corrective Actions

objective evidence
Objective evidence
  • Factual evidence of differences between the Quality manual and procedures and the audit criteria
  • Factual evidence of differences between procedures and working practices
  • Lack of evidence to support implementation of various standard clauses
  • Lack of evidence to show continuous implementation of various parts of the system

Nonconformity

Reports and Corrective Actions

slide50
NCR
  • Report what was wrong
  • Explain the requirement that was contravened
  • To assist investigation
  • As self check, to avoid “inventing the requirements”

Nonconformity

Reports and Corrective Actions

grading nonconformities
Grading nonconformities
  • based on impact on the system
  • Do not consider impact on product quality
  • Do not consider potential financial applications

Nonconformity

Reports and Corrective Actions

major nonconformity
Major nonconformity
  • Failure to address the clause of the standard or element of other audit criteria
  • Systematic failure to comply with the requirement

Nonconformity

Reports and Corrective Actions

minor nonconformity
Minor nonconformity
  • Isolated lapse, non-systematic failure
  • Minor nonconformity may have very heavy impact on product quality or financial performance!

Nonconformity

Reports and Corrective Actions

scenario production lens department w 4 morning shift
Scenario:Production – Lens Department W-4Morning shift.
  • 4 out of 18 operatives seen not wearing head gear (nylon caps). Caps were available at the entrance area.
  • WI4-01, clause 6, requires that all personel entering W-4 must wear nylon caps. Instruction clearly displayed at the entrance.

Nonconformity

Reports and Corrective Actions

scenario production lens department w 4 morning shift55
Scenario:Production – Lens Department W-4Morning shift.
  • Area
  • Problem
  • Requirement(s)
  • Attribution
  • Sign
  • Grading
scenario
Scenario:

Production – sheet metal fabrication. Section W-6 Station KT 10 – dimensional inspection against drawings TT-100-01, TT-100-02 (approved for production). Drawings show nominal dimensions only. Acceptable tolerances not specified in the drawings. Checked with design department and schedule of tolerances not available.

Nonconformity

Reports and Corrective Actions

caution
Caution
  • Be cautious, do not be over conclusive!
  • Don’t judge on face value!
  • Make sure you have complete evidence!
  • Make sure your evidence is objective!
  • When in doubt, investigate!
  • Identify the leads for further investigation

Nonconformity

Reports and Corrective Actions

example of note
Example of Note

Production – Paints Department

Pressure gauge Tag # 017 – no calibration sticker.

Check with QC:

  • What is it for? Any impact on quality?
  • Is calibration required?
  • Was it calibrated? See the records.
  • Why there is no tag?
  • Check procedure.

Nonconformity

Reports and Corrective Actions

matrix or cluster analysis
Matrix or cluster analysis
  • Is the system fundamentally sound?
  • Are there any problem areas?
  • Are there weak elements in the system?

Nonconformity

Reports and Corrective Actions

slide61
Corrective Action

“Action to eliminate the causes of a detected nonconformity or other undesirable situation”

ISO 9000:2000

Nonconformity

Reports and Corrective Actions

slide62

Auditor

Auditee

Identify, note &

Communicate

Agreement

Acknowledge

& investigate

Prepare NCR

Propose

Corrective Action

Agreement

Review

effectiveness

Implement

Verify & notify

Nonconformity

Reports and Corrective Actions

ad