Chapter 4
Download
1 / 62

Chapter 4 Prevention Versus Detection - PowerPoint PPT Presentation


  • 124 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 l.jpg

Chapter 4

Prevention Versus Detection

Prevention Versus Detection


Benefits of implementation of iso 9001 l.jpg
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 l.jpg
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 l.jpg
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 l.jpg
Categories of quality costs:

  • Costs of prevention

  • Appraisal costs

  • Failure and rectification costs

Prevention Versus Detection


Prevention costs l.jpg
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 l.jpg
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 l.jpg
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 l.jpg
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 l.jpg

Which clauses in ISO 9001 have particularly preventative character?

Prevention Versus Detection


Chapter 5 l.jpg
Chapter 5 character?

Quality System

Documentation

Prevention Versus Detection


Function and value of system documentation l.jpg
Function and value of system documentation character?

  • 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 l.jpg

Documents and records(ISO 9000:2000) character?

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 l.jpg
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 l.jpg
Typical structure of quality system documentation (ISO 9001:2000 Clause 4.2.1 Note 3)

Quality

Manual

Procedures

Work Instructions

External

Documents

Forms

Quality System Documentation


General rule l.jpg
General rule: (ISO 9001:2000 Clause 4.2.1 Note 3)

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

Quality System Documentation


Purpose of quality manual l.jpg
Purpose of quality manual (ISO 9001:2000 Clause 4.2.1 Note 3)

  • 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 l.jpg
Quality manual (ISO 9000:2000) (ISO 9001:2000 Clause 4.2.1 Note 3)

“Document specifying the quality management system of an organisation”

Quality System Documentation


Quality manual can iso 10013 l.jpg
Quality manual can (ISO 10013): (ISO 9001:2000 Clause 4.2.1 Note 3)

  • 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 l.jpg
Typical contents of the quality manual: (ISO 9001:2000 Clause 4.2.1 Note 3)

  • 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 l.jpg
Procedures (ISO 9001:2000 Clause 4.2.1 Note 3)ISO 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 l.jpg
Procedure needs to answer the following questions: (ISO 9001:2000 Clause 4.2.1 Note 3)

  • What?

  • Why?

  • Who?

  • Where?

  • When?

  • How?

    In other words to define the process

Quality System Documentation


Chapter 6 l.jpg
Chapter 6 (ISO 9001:2000 Clause 4.2.1 Note 3)

Introduction to Audits

Introduction to Audits


Slide24 l.jpg

(ISO 9001:2000 Clause 4.2.1 Note 3)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 l.jpg
Purpose of the audit (ISO 9001:2000 Clause 4.2.1 Note 3)

  • 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 l.jpg
Reasons to conduct an audit (ISO 9001:2000 Clause 4.2.1 Note 3)

  • new suppliers

  • regular review of suppliers

  • contractual requirement

  • changes in the system

  • increased orders

  • quality problems

Introduction to Audits


Benefits l.jpg
Benefits (ISO 9001:2000 Clause 4.2.1 Note 3)

  • 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 l.jpg
Classification of audits (ISO 9001:2000 Clause 4.2.1 Note 3)

  • 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 l.jpg
Initial documentation review (ISO 9001:2000 Clause 4.2.1 Note 3)(Adequacy, desktop, intent audit)

?

QMS Manual

Audit Criteria

=

Use checklist

Introduction to Audits


Benefits of initial documentation review l.jpg
Benefits of initial documentation review (ISO 9001:2000 Clause 4.2.1 Note 3)

  • 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 l.jpg
Conformance (or implementation) audit (ISO 9001:2000 Clause 4.2.1 Note 3)

?

QMS Manual

=

Work practices

Introduction to Audits


Understand the difference l.jpg
Understand the difference (ISO 9001:2000 Clause 4.2.1 Note 3)

Conformance

with the audit

criteria

Legal

Compliance

Introduction to Audits


Types of certification audits l.jpg
Types of Certification Audits (ISO 9001:2000 Clause 4.2.1 Note 3)

  • Initial or certification audit

  • Surveillance Audit

  • Re-certification Audit

Introduction to Audits


Iso 10011 guidelines for auditing quality systems l.jpg
ISO 10011 Guidelines for auditing quality systems (ISO 9001:2000 Clause 4.2.1 Note 3)

  • Part 1: Auditing

  • Part 2: Qualification criteria for quality systems auditors

  • Part 3: Management of audit programmes

Introduction to Audits


Iso 10011 1 auditing l.jpg

Audit objectives (ISO 9001:2000 Clause 4.2.1 Note 3)

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 l.jpg
ISO 10011 (ISO 9001:2000 Clause 4.2.1 Note 3)– 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 l.jpg
ISO 10011 (ISO 9001:2000 Clause 4.2.1 Note 3)– 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 l.jpg
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 l.jpg
Fundamentals of auditing auditing (will replace ISO 10011)– 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 l.jpg
Management of audit programmes auditing (will replace ISO 10011)

  • 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 l.jpg
Auditing activities auditing (will replace ISO 10011)

  • 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 l.jpg

Personal attributes auditing (will replace ISO 10011)

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 l.jpg
Chapter 7 auditing (will replace ISO 10011)

Nonconformity

Reports and Corrective Actions

Nonconformity

Reports and Corrective Actions


Slide44 l.jpg

Nonconformity: auditing (will replace ISO 10011)“Nonfulfilment of a requirement”

ISO 9000:2000

Nonconformity

Reports and Corrective Actions


Slide45 l.jpg

  • Be positive auditing (will replace ISO 10011)

  • Do not view nonconformity in a negative way

  • Uncovering nonconformity presents an opportunity for improvement though corrective action

Nonconformity

Reports and Corrective Actions


Slide46 l.jpg
NCR auditing (will replace ISO 10011)

  • 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 l.jpg

Example of form auditing (will replace ISO 10011)

Nonconformity

Reports and Corrective Actions


Nonconformity report l.jpg
Nonconformity Report auditing (will replace ISO 10011)

  • Clear and precise

  • Concise and accurate

  • Comprehensive

  • Describe problem

  • Explain the requirement

  • Reference the evidence

Nonconformity

Reports and Corrective Actions


Objective evidence l.jpg
Objective evidence auditing (will replace ISO 10011)

  • 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 l.jpg
NCR auditing (will replace ISO 10011)

  • 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 l.jpg
Grading nonconformities auditing (will replace ISO 10011)

  • 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 l.jpg
Major nonconformity auditing (will replace ISO 10011)

  • 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 l.jpg
Minor nonconformity auditing (will replace ISO 10011)

  • 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 l.jpg
Scenario: auditing (will replace ISO 10011)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 l.jpg
Scenario: auditing (will replace ISO 10011)Production – Lens Department W-4Morning shift.

  • Area

  • Problem

  • Requirement(s)

  • Attribution

  • Sign

  • Grading


Scenario l.jpg
Scenario: auditing (will replace ISO 10011)

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 l.jpg
Caution auditing (will replace ISO 10011)

  • 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 l.jpg
Example of Note auditing (will replace ISO 10011)

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 l.jpg
Matrix or cluster analysis auditing (will replace ISO 10011)

  • Is the system fundamentally sound?

  • Are there any problem areas?

  • Are there weak elements in the system?

Nonconformity

Reports and Corrective Actions


Slide61 l.jpg

Corrective Action auditing (will replace ISO 10011)

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

ISO 9000:2000

Nonconformity

Reports and Corrective Actions


Slide62 l.jpg

Auditor auditing (will replace ISO 10011)

Auditee

Identify, note &

Communicate

Agreement

Acknowledge

& investigate

Prepare NCR

Propose

Corrective Action

Agreement

Review

effectiveness

Implement

Verify & notify

Nonconformity

Reports and Corrective Actions


ad