Soumettre la recherche
Mettre en ligne
Slide 4 v6
•
Télécharger en tant que PPT, PDF
•
3 j'aime
•
2,434 vues
Paul Robere
Suivre
ISO/TS16949 Supplement Training
Lire moins
Lire la suite
Signaler
Partager
Signaler
Partager
1 sur 57
Télécharger maintenant
Recommandé
Slide 3 v6
Slide 3 v6
Paul Robere
Atul_Oracle Functional Distribution and WMS Consultant
Atul_Oracle Functional Distribution and WMS Consultant
Atul Kumar
Dion[1] 9100
Dion[1] 9100
ahmad bassiouny
Sudheer kudidala resume
Sudheer kudidala resume
Sudheer Kudidala
Avionics Software Standards
Avionics Software Standards
Sushma Reddy
Standards for safety and security in avionics
Standards for safety and security in avionics
Alessandro Bruni
A successful improvement process with measurable results
A successful improvement process with measurable results
Ram Yonish
Avionics Software Standards ppt in latex
Avionics Software Standards ppt in latex
Sushma Reddy
Recommandé
Slide 3 v6
Slide 3 v6
Paul Robere
Atul_Oracle Functional Distribution and WMS Consultant
Atul_Oracle Functional Distribution and WMS Consultant
Atul Kumar
Dion[1] 9100
Dion[1] 9100
ahmad bassiouny
Sudheer kudidala resume
Sudheer kudidala resume
Sudheer Kudidala
Avionics Software Standards
Avionics Software Standards
Sushma Reddy
Standards for safety and security in avionics
Standards for safety and security in avionics
Alessandro Bruni
A successful improvement process with measurable results
A successful improvement process with measurable results
Ram Yonish
Avionics Software Standards ppt in latex
Avionics Software Standards ppt in latex
Sushma Reddy
DO-178B/ED-12B Presentation
DO-178B/ED-12B Presentation
Ankit Singh
RESUME of Sid_Hebron_NEW
RESUME of Sid_Hebron_NEW
Sid de Leon II
Do 178 B Summary
Do 178 B Summary
martin allen
How to make the step from testing to QA
How to make the step from testing to QA
SYSQA BV
Curriculum Vitae 2016_updated
Curriculum Vitae 2016_updated
Bernard Campecino
Quality in Software Testing
Quality in Software Testing
360logica Software Testing Services (A Saksoft Company)
DO254 DMAP Training 2011 Trailer
DO254 DMAP Training 2011 Trailer
DMAP
Introduction to DO-178B - Software Considerations in Airborne Systems and Equ...
Introduction to DO-178B - Software Considerations in Airborne Systems and Equ...
Swamy Shettru
The Automation Revolution - RAD
The Automation Revolution - RAD
qualisystems
Code Coverage in Theory and in practice form the DO178B perspective
Code Coverage in Theory and in practice form the DO178B perspective
Engineering Software Lab
Daidalos Integration Framework TridentCom 2007
Daidalos Integration Framework TridentCom 2007
Miguel Ponce de Leon @ TSSG / Waterford Institute of Technology
Anindam_Resume
Anindam_Resume
Anindam Biswas
My CV
My CV
Gary J. O'Gorman
What is Design Assurance Engineering (DAE)?
What is Design Assurance Engineering (DAE)?
Society of Women Engineers
CON4199-Architectural Design Choices to Support DevOps for PeopleSoft Systems...
CON4199-Architectural Design Choices to Support DevOps for PeopleSoft Systems...
Brennan Folmer
Qualification dqiqoq
Qualification dqiqoq
hoanhhai12345
Top 10 uses of Functional Size Measurement (Function Points) by Mature Orga...
Top 10 uses of Functional Size Measurement (Function Points) by Mature Orga...
Carol Dekkers
Bogdan Mircea Tomescu Presentation
Bogdan Mircea Tomescu Presentation
Mircea Tomescu
Deployment Methodology
Deployment Methodology
David Messineo
Corrective action
Corrective action
Khaled Tarawneh
Professor Yakub Aliyu Product Quality Non Conformance presentation -v1.4_11...
Professor Yakub Aliyu Product Quality Non Conformance presentation -v1.4_11...
Professor Yakub Aliyu
Audit
Audit
Prasenjit Mondal
Contenu connexe
Tendances
DO-178B/ED-12B Presentation
DO-178B/ED-12B Presentation
Ankit Singh
RESUME of Sid_Hebron_NEW
RESUME of Sid_Hebron_NEW
Sid de Leon II
Do 178 B Summary
Do 178 B Summary
martin allen
How to make the step from testing to QA
How to make the step from testing to QA
SYSQA BV
Curriculum Vitae 2016_updated
Curriculum Vitae 2016_updated
Bernard Campecino
Quality in Software Testing
Quality in Software Testing
360logica Software Testing Services (A Saksoft Company)
DO254 DMAP Training 2011 Trailer
DO254 DMAP Training 2011 Trailer
DMAP
Introduction to DO-178B - Software Considerations in Airborne Systems and Equ...
Introduction to DO-178B - Software Considerations in Airborne Systems and Equ...
Swamy Shettru
The Automation Revolution - RAD
The Automation Revolution - RAD
qualisystems
Code Coverage in Theory and in practice form the DO178B perspective
Code Coverage in Theory and in practice form the DO178B perspective
Engineering Software Lab
Daidalos Integration Framework TridentCom 2007
Daidalos Integration Framework TridentCom 2007
Miguel Ponce de Leon @ TSSG / Waterford Institute of Technology
Anindam_Resume
Anindam_Resume
Anindam Biswas
My CV
My CV
Gary J. O'Gorman
What is Design Assurance Engineering (DAE)?
What is Design Assurance Engineering (DAE)?
Society of Women Engineers
CON4199-Architectural Design Choices to Support DevOps for PeopleSoft Systems...
CON4199-Architectural Design Choices to Support DevOps for PeopleSoft Systems...
Brennan Folmer
Qualification dqiqoq
Qualification dqiqoq
hoanhhai12345
Top 10 uses of Functional Size Measurement (Function Points) by Mature Orga...
Top 10 uses of Functional Size Measurement (Function Points) by Mature Orga...
Carol Dekkers
Bogdan Mircea Tomescu Presentation
Bogdan Mircea Tomescu Presentation
Mircea Tomescu
Deployment Methodology
Deployment Methodology
David Messineo
Tendances
(19)
DO-178B/ED-12B Presentation
DO-178B/ED-12B Presentation
RESUME of Sid_Hebron_NEW
RESUME of Sid_Hebron_NEW
Do 178 B Summary
Do 178 B Summary
How to make the step from testing to QA
How to make the step from testing to QA
Curriculum Vitae 2016_updated
Curriculum Vitae 2016_updated
Quality in Software Testing
Quality in Software Testing
DO254 DMAP Training 2011 Trailer
DO254 DMAP Training 2011 Trailer
Introduction to DO-178B - Software Considerations in Airborne Systems and Equ...
Introduction to DO-178B - Software Considerations in Airborne Systems and Equ...
The Automation Revolution - RAD
The Automation Revolution - RAD
Code Coverage in Theory and in practice form the DO178B perspective
Code Coverage in Theory and in practice form the DO178B perspective
Daidalos Integration Framework TridentCom 2007
Daidalos Integration Framework TridentCom 2007
Anindam_Resume
Anindam_Resume
My CV
My CV
What is Design Assurance Engineering (DAE)?
What is Design Assurance Engineering (DAE)?
CON4199-Architectural Design Choices to Support DevOps for PeopleSoft Systems...
CON4199-Architectural Design Choices to Support DevOps for PeopleSoft Systems...
Qualification dqiqoq
Qualification dqiqoq
Top 10 uses of Functional Size Measurement (Function Points) by Mature Orga...
Top 10 uses of Functional Size Measurement (Function Points) by Mature Orga...
Bogdan Mircea Tomescu Presentation
Bogdan Mircea Tomescu Presentation
Deployment Methodology
Deployment Methodology
En vedette
Corrective action
Corrective action
Khaled Tarawneh
Professor Yakub Aliyu Product Quality Non Conformance presentation -v1.4_11...
Professor Yakub Aliyu Product Quality Non Conformance presentation -v1.4_11...
Professor Yakub Aliyu
Audit
Audit
Prasenjit Mondal
Public fiscal admin report
Public fiscal admin report
Louie Medinaceli
Root Cause And Corrective Action Workshop Cinci Asq 2009
Root Cause And Corrective Action Workshop Cinci Asq 2009
roycohen
Auditing-definition & objective of auditing
Auditing-definition & objective of auditing
Ravi kumar
Tqm quality audit
Tqm quality audit
premsruthi
Public fiscal adm pwrpt
Public fiscal adm pwrpt
Green Minds
Iso Process Audit Training
Iso Process Audit Training
srmortensen
Philippine Public Fiscal Administration by Daisy T. Besing (MPA)
Philippine Public Fiscal Administration by Daisy T. Besing (MPA)
Daisy Besing
Quality audit
Quality audit
Dolita-Shah
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
DQS Inc.
Auditing principle and objective
Auditing principle and objective
student
Basic Internal Auditing Presentation
Basic Internal Auditing Presentation
Vernon Benjamin
Audit Process, Audit Procedures, Audit Planning, Auditing
Audit Process, Audit Procedures, Audit Planning, Auditing
Advance Business Consulting
En vedette
(15)
Corrective action
Corrective action
Professor Yakub Aliyu Product Quality Non Conformance presentation -v1.4_11...
Professor Yakub Aliyu Product Quality Non Conformance presentation -v1.4_11...
Audit
Audit
Public fiscal admin report
Public fiscal admin report
Root Cause And Corrective Action Workshop Cinci Asq 2009
Root Cause And Corrective Action Workshop Cinci Asq 2009
Auditing-definition & objective of auditing
Auditing-definition & objective of auditing
Tqm quality audit
Tqm quality audit
Public fiscal adm pwrpt
Public fiscal adm pwrpt
Iso Process Audit Training
Iso Process Audit Training
Philippine Public Fiscal Administration by Daisy T. Besing (MPA)
Philippine Public Fiscal Administration by Daisy T. Besing (MPA)
Quality audit
Quality audit
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
Auditing principle and objective
Auditing principle and objective
Basic Internal Auditing Presentation
Basic Internal Auditing Presentation
Audit Process, Audit Procedures, Audit Planning, Auditing
Audit Process, Audit Procedures, Audit Planning, Auditing
Similaire à Slide 4 v6
Phase II CoA_SIT_AU and PNG.pptx
Phase II CoA_SIT_AU and PNG.pptx
ssuser23cbfc
Gamification in outsourcing company: experience report.
Gamification in outsourcing company: experience report.
Mikalai Alimenkou
Николай Алименков "Геймификация в аутсорсинговых компаниях: практический отчет"
Николай Алименков "Геймификация в аутсорсинговых компаниях: практический отчет"
Fwdays
ICANN.org - Application & evaluation process
ICANN.org - Application & evaluation process
newdomains.org - The Munich Conference on new gTLDs
How to play Golf on the first day of Go-Live for a JD Edwards EnterpriseOne ...
How to play Golf on the first day of Go-Live for a JD Edwards EnterpriseOne ...
KPIT
Vidhya Sr QC Resume
Vidhya Sr QC Resume
Vidya Chandodi
Vidhya SR QC Resume
Vidhya SR QC Resume
Vidya Chandodi
Gavish_Sharma Resume
Gavish_Sharma Resume
Gavish Sharma
Amit_Resume
Amit_Resume
amit dave
A Successful Improvement Process With Measurable Results
A Successful Improvement Process With Measurable Results
Ram Yonish
Good IT Project Management
Good IT Project Management
William Francis
Certification in Data Management
Certification in Data Management
L_MahonSmith
Tqm2
Tqm2
Paul Robere
Use Cases for ISO20000-1 based on ITIL in English 【Continuous Study】
Use Cases for ISO20000-1 based on ITIL in English 【Continuous Study】
Jerimi Soma
Removing Crucial Dependencies to Enable KPN as a Virtual Telecom Provider
Removing Crucial Dependencies to Enable KPN as a Virtual Telecom Provider
CA Technologies
Con8208 achieve a quicker and compliant financial close
Con8208 achieve a quicker and compliant financial close
Oracle
GVL.Naidu_CV_QA
GVL.Naidu_CV_QA
Venkatalakshmana Naidu Gunuru
Gopals_latest_resume
Gopals_latest_resume
gopal ananthanarayanan
20211114 Agile DevOps East Conf 2021 Bringing DevOps to an Entrenched Legacy ...
20211114 Agile DevOps East Conf 2021 Bringing DevOps to an Entrenched Legacy ...
Craeg Strong
Thailand SPIN Day 2014: มิตร ศัตรู หรือความไม่รู้ต่างหากที่หลอกเรา (29/5/2557...
Thailand SPIN Day 2014: มิตร ศัตรู หรือความไม่รู้ต่างหากที่หลอกเรา (29/5/2557...
Apple Taton
Similaire à Slide 4 v6
(20)
Phase II CoA_SIT_AU and PNG.pptx
Phase II CoA_SIT_AU and PNG.pptx
Gamification in outsourcing company: experience report.
Gamification in outsourcing company: experience report.
Николай Алименков "Геймификация в аутсорсинговых компаниях: практический отчет"
Николай Алименков "Геймификация в аутсорсинговых компаниях: практический отчет"
ICANN.org - Application & evaluation process
ICANN.org - Application & evaluation process
How to play Golf on the first day of Go-Live for a JD Edwards EnterpriseOne ...
How to play Golf on the first day of Go-Live for a JD Edwards EnterpriseOne ...
Vidhya Sr QC Resume
Vidhya Sr QC Resume
Vidhya SR QC Resume
Vidhya SR QC Resume
Gavish_Sharma Resume
Gavish_Sharma Resume
Amit_Resume
Amit_Resume
A Successful Improvement Process With Measurable Results
A Successful Improvement Process With Measurable Results
Good IT Project Management
Good IT Project Management
Certification in Data Management
Certification in Data Management
Tqm2
Tqm2
Use Cases for ISO20000-1 based on ITIL in English 【Continuous Study】
Use Cases for ISO20000-1 based on ITIL in English 【Continuous Study】
Removing Crucial Dependencies to Enable KPN as a Virtual Telecom Provider
Removing Crucial Dependencies to Enable KPN as a Virtual Telecom Provider
Con8208 achieve a quicker and compliant financial close
Con8208 achieve a quicker and compliant financial close
GVL.Naidu_CV_QA
GVL.Naidu_CV_QA
Gopals_latest_resume
Gopals_latest_resume
20211114 Agile DevOps East Conf 2021 Bringing DevOps to an Entrenched Legacy ...
20211114 Agile DevOps East Conf 2021 Bringing DevOps to an Entrenched Legacy ...
Thailand SPIN Day 2014: มิตร ศัตรู หรือความไม่รู้ต่างหากที่หลอกเรา (29/5/2557...
Thailand SPIN Day 2014: มิตร ศัตรู หรือความไม่รู้ต่างหากที่หลอกเรา (29/5/2557...
Plus de Paul Robere
Tpm new
Tpm new
Paul Robere
Tpm basic
Tpm basic
Paul Robere
Tpm principles and concepts
Tpm principles and concepts
Paul Robere
Words to the_wise_0911
Words to the_wise_0911
Paul Robere
Quality136 tp 060509
Quality136 tp 060509
Paul Robere
Ibi
Ibi
Paul Robere
Lm
Lm
Paul Robere
Mm
Mm
Paul Robere
Rcm
Rcm
Paul Robere
Tpm
Tpm
Paul Robere
Scm v20
Scm v20
Paul Robere
Kpi 1 day
Kpi 1 day
Paul Robere
14 epi-e-dn v.1.01(draft)
14 epi-e-dn v.1.01(draft)
Paul Robere
8 qmp
8 qmp
Paul Robere
7 new qc tools
7 new qc tools
Paul Robere
5 s training
5 s training
Paul Robere
Hr pts-e-dn-version 2.0
Hr pts-e-dn-version 2.0
Paul Robere
Train the trainer
Train the trainer
Paul Robere
Hr tit-e-dn
Hr tit-e-dn
Paul Robere
Business writing
Business writing
Paul Robere
Plus de Paul Robere
(20)
Tpm new
Tpm new
Tpm basic
Tpm basic
Tpm principles and concepts
Tpm principles and concepts
Words to the_wise_0911
Words to the_wise_0911
Quality136 tp 060509
Quality136 tp 060509
Ibi
Ibi
Lm
Lm
Mm
Mm
Rcm
Rcm
Tpm
Tpm
Scm v20
Scm v20
Kpi 1 day
Kpi 1 day
14 epi-e-dn v.1.01(draft)
14 epi-e-dn v.1.01(draft)
8 qmp
8 qmp
7 new qc tools
7 new qc tools
5 s training
5 s training
Hr pts-e-dn-version 2.0
Hr pts-e-dn-version 2.0
Train the trainer
Train the trainer
Hr tit-e-dn
Hr tit-e-dn
Business writing
Business writing
Slide 4 v6
1.
Post-Audit Activities
“The Job’s not done until the paperwork is done”… 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 1
2.
Day 4 –
Post-Audit Activities 1. Review of previous day 2. Recording the audit Did I Pass? 3. Grading NCR’s 4. Closing Meeting 5. Corrective Action & follow-up 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 2
3.
REVIEW OF DAY-THREE:
10 minutes review It is important that we begin each day with a review of the previous day’s activities. Each day lays the foundation for the upcoming subject topics. 1. Review Homework 2. What are the areas that were unclear? 3. Identify topic areas that you want reviewed from yesterday’s activities. 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 3
4.
Stage Four: Report
The Audit • Recording the Audit • Grading NCR’s • Closing Meeting 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 4
5.
RECORDING THE AUDIT
9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 5
6.
Positive Reporting
• Say what was done • Say what was seen • Say what was good: • use of well designed methods • well run production team • advanced manufacturing techniques • ownership of quality 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 6
7.
Report ‘Who, What
and Where’ • Report reference • Auditee/location/dates • Purpose/scope • Reference documents • Audit team 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 7
8.
Key Items
• Non-conformities • Summary statement/Recommendations • Signature of Audit Team Leader • Signature of the Auditee • Further action required 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 8
9.
Other important details
• Distribution list • Attendees at opening and closing meetings • Auditee representatives • Audit program 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 9
10.
Audit Report
• Communication tool – It stays with the Auditee long after the audit team have gone home – Should be legible – Contain information appropriate to the audit (Relevant to the activity) 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 10
11.
Audit Records
– Audit Plan – Audit Schedule – Audit Report – Correct Action Program – Non-Conformance Analysis – Auditor Notes 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 11
12.
END
9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 12
13.
Team Exercise:
D4-E01: Recording Non-conformities 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 13
14.
GRADING
NCR’s 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 14
15.
Non-conformity: A Definition
“The non-fulfillment of a requirement” (ISO 9000 : 2000 – 3.6.2) 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 15
16.
Non-conformity: Other Terms
• Non-conformance • Deficiency • Discrepancy • Finding • Non-Conformity • Corrective Action Request (CAR) • Deviation 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 16
17.
Categories of Nonconformities
MAJOR nonconformity: The absence of a required procedure or total breakdown of a procedure or process. Significant failure to conform with requirement Breakdown of a key aspect of the quality management system A number of minor nonconformities listed against the same requirement 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 17
18.
Categories of Non-conformities
• MINOR non-conformity: A single observed lapse in a procedure isolated non-fulfillment of specified requirement negligible effect on quality 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 18
19.
Observations
In some circumstances it may add value to also include ‘Observations’ which: “relate to existing conditions and which, in an assessor’s judgement, warrant clarification or investigation so as to improve the overall status and effectiveness of the quality system” 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 19
20.
Reasons for Nonconformities
• Process not in conformance with quality manual • Written procedures not implemented in the process • Process is ineffective 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 20
21.
Always Remember
Auditing is looking for conformance BUT…… you should not shy away if there is something to find! 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 21
22.
Non-conformity Statements
• The facts: • where • what • why - nature of the non-conformity • ISO 9001 clause • Documented Quality Management System reference 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 22
23.
Recording Non-conformities
• The findings: • the facts • acknowledged by auditee • at the time they are found • Non-conformity statements must be: • accurate • complete • helpful • brief 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 23
24.
Handling Possible MAJOR
Non- conformities • Major non-conformities - always: – inform the Lead Auditor at the earliest opportunity – do not alarm the auditee or interviewee – follow the certification body’s procedures Remember: a MAJOR is defined as the absence of or breakdown of a required Quality Management System Element 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 24
25.
Example Non-conformity Form
ROBERE QUALITY AUDIT NONCONFORMITY REPORT Company under Audit: XYZ plc Nonconformity Number ................... Area under review: ISO 9001 Clause Number ............... .............................................................................. Category MAJOR* MINOR* * delete one Nonconformity Auditor 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 25
26.
Summary •
The Audit Report is the formal record of the audit and: • contains all information about the audit • will be read by people not involved in the audit • Non-conformity statements must: • cover the facts, clearly and specifically • be acknowledged by auditee at the time they are found and be: » accurate » complete » helpful » brief 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 26
27.
END
9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 27
28.
Team Exercise
D4-E02: Grading NCR’s 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 28
29.
CLOSING
MEETING 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 29
30.
Pre-Closing Meeting
• Review findings • Agree non-conformities • Write non-conformity statements • Write summary statement • Prepare agenda • Team form an agreement on assessment outcome ©Robere & Associates (Thailand) 2000 9K2K-LAD-E-IG-D4 Ver 6 30
31.
Closing Meeting :
Agenda • Thank you • Purpose • Confirmation of scope • Sample • Findings • Summary • Follow-up activity • Clarify • Report availability • Go 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 31
32.
Closing Meeting Conduct
• Lead Auditor's meeting • Keep to the agenda • Keep it short • Keep a record (attendees) • End on a positive note 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 32
33.
Summary Statement–
Version 1 This Company has a Quality Management System which is well documented and generally in conformance with the requirements of ISO 9001:2000. However,the systems and procedures have not been fully implemented in the contract, project management and product shipment areas. The audit found 33 non-conformities and particular concern is felt for: • Lack of application of the system for review of the quality requirements of contracts. • Evidence of a lack of disciplined control toward customer complaints and related follow-up actions. • Lack of quality awareness on the part of project and senior management personnel. 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 33
34.
Summary Statement–
Version 1 • No significant problems were found in the activities of either the Design or pre-sales teams. • There is a need for more frequent review of the Quality Manual and project management procedures. • It will therefore be necessary for the company to undertake corrective action on the deficiencies raised and for a further audit to be carried out to verify that it has been taken before the company can be awarded a certificate. Corrective action should be effected within three months from today. 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 34
35.
Summary Statement–
Version 2 There are important omissions in the Quality Management System operated by the company, although what exists is mostly in line with the requirements of ISO 9001:2000. It has also been found that the systems and procedures, which do exist, have not been universally implemented, particularly related To the review of contracts, project planning and customer-relations areas. The audit found 33 deficiencies of which 4 were considered to be major. Particular concern is felt for: • Lack of a system for reviewing the requirements of contracts. •The absence of planning and progress control on work not directly related to customer contracts. •The effect that the current lack of control of customer complaints and follow-up actions may cause. 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 35
36.
Summary Statement–
Version 2 No significant problems were found in the activities of either the Design or Pre-sales teams. There is a need for more frequent review of the Quality Manual and software development procedures. The most important conclusion is that there is a need for more senior management involvement in and support for implementation of the documented system. Until this is established and the declared Quality System is applied consistently and effectively throughout the company, it will not be possible to grant certification. It is recommended that the company takes appropriate corrective action and re-applies for assessment when all of the above concerns and deficiencies have been addressed. 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 36
37.
Summary
• Be prepared before meeting • Ensure there are NO surprises for the auditee • Stick to the prepared agenda • Don’t be drawn into discussion • Ensure the auditee is clear as to the next step 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 37
38.
END
9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 38
39.
Team Exercise:
D4-E03: Role-Play: Closing Meeting 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 39
40.
Stage Five:
CORRECTIVE ACTIONS & FOLLOW UP 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 40
41.
Corrective Actions Process
Stage 1 Initiation of Non-conformity Auditor Stage 2 Provide Programme of CA Auditee Stage 3 Submit CA Programme to Auditor Auditee Stage 4 Analysis of CA Programme Auditor Stage 5 Monitoring,Reviewing,Auditing Auditee Stage 6 Verify and closing Auditor ACCEPT 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 41
42.
Stage 1–Initiation of
Non-conformity • The Auditor raises the problem: • the facts • the non-conformity • the department responsible 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 42
43.
Stage 2–Provide Program
of Corrective Action • The Auditee Response – Root cause analysis – Corrective action – Preventive action – Approval – The organization's Quality Assurance function provides advice to the responsible manager 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 43
44.
Stage 3 –
Submit Corrective Action Program to Auditor • The auditee responds: – with proposed corrective action – and identifies root cause of non- conformity – and initiates action to prevent recurrence – with target date for completion 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 44
45.
Stage 4 –
Analysis of Corrective Action Program • The auditor responds: – analysis of the Corrective Action Program against the original NC Statement 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 45
46.
Stage 5 -
Monitoring, Reviewing, Auditing • The auditee responds: – Procedures required – Use of status log – Corrective action review meetings – The auditee notifies the auditor when the actions are complete 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 46
47.
Stage 6 -
Verify and Closing • The auditor responds: – Verify the implementation of some actions prior to the report close – If Corrective Action is satisfactory, close out the report 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 47
48.
Example:
Corrective Action Status Log CAR Date Subject Initiator CAR Response Approval of Verified Closed Nos. Issued of Report Sent To Due Date Response by (Name) (Date) (Name & Date) 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 48
49.
Example Corrective Action
Form Auditee Representative Auditor Date: Report Nos. Standard ref.: Doc. Ref. Details of Non-conformance Non conformance Accepted By Immediate Action Preventive Action Corrective Action Verified by Name Date 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 49
50.
Additional Key Point
The Auditee role: – Look across the organization to identify the other possible area where the same problem may occur but was not necessarily identified during the audit. – May provide opportunity to prevent problems before they arise. – Using a structured problem solving technique to correct the problem. 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 50
51.
Summary: Auditor Role
• Communicating/explaining the audit report to the auditee • Eliciting a response from the auditee as to corrective action • Evaluating the auditee's response • Agreeing the corrective action proposed • Verifying that corrective action has been taken • Closing out the follow-up 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 51
52.
Summary: Auditee Role
• Examines the evidence • Identifies immediate action needs and act • Check corrective action effectiveness • Establish root cause • Identify action to prevent recurrence • Implement action to prevent recurrence 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 52
53.
END
9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 53
54.
Team Exercise: D4-E04: Corrective
Action 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 54
55.
Day-Four Summary:
We reviewed yesterdays activities We discussed how to record the results of the audit by using an exercise based on previous evaluations We continued with our discussion about the audit and about the follow-up activities that we are to perform. We discussed how to grade NCR: Major and Minor We discussed how to report the non-conformances to that our auditee can understand what type of corrective action needs to be taken. We discussed the format and agenda of the closing meeting. We reviewed examples of summary statements that would give us an idea of how to structure our report. We discussed Corrective Actions and what we should expect from our auditee if corrective action was necessary. 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 55
56.
End of Day
Four Only one-day left.. 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 56
57.
END
Team Homework 9K2K-LAD-E-IG-D4 Ver 6 ©Robere & Associates (Thailand) 2000 57
Télécharger maintenant