SlideShare a Scribd company logo
1 of 19
NON CONFORMANCE
REPORTING
INTEGRATED MANAGEMENT SYSTEM
PCD-QSC-SOP-05,06
WHAT IS AN NCR ?
• A report issued when a product, process or
procedure does not comply with the set
standards for a product, process or
procedure under inspection.
• An NCR is any significant deficiency.
• A means of tracking actions.
• A tool to put right things that are going
wrong.
• A means of stopping repeated errors.
WHAT IS AN NCR ?
• NCR’s are used to record findings from
internal and external audits that
require addressing.
• Work that was not built as indicated in
approved drawings
• Work that fails to meet specified
tolerances as established in project
specifications.
WHAT IS AN NCR ?
• Work that is being performed using non-
approved methods or standards
• When the testing and inspection plan is not
followed as agreed
• When testing results demonstrate that the
product does not meet established and
approved standards
• When a material is used and has not been
approved as a substitute (equal or similar)
When design is not accurate and
does not represents actual field
conditions
When the approved procedure was
not followed and quality defects
have been identify by the project
team.
THE IMPORTANCE OF
NON CONFORMANCE
REPORTING
For want of a nail a shoe was lost,
for want of a shoe a horse was lost,
for want of a horse a rider was lost,
for want of a rider an army was lost,
for want of an army a battle was lost,
for want of a battle the war was lost,
for want of the war the kingdom was lost,
And all for the want of a little horseshoe
nail.
5 Why Questions?
Why was the Kingdom lost?
Because the war was lost.
Why was the war lost?
Because the battle was lost.
Why was the battle lost?
Because the army was lost.
Why was the army lost?
Because the rider was lost.
Why was the rider lost?
Because the horse was lost.
Why was the horse lost?
Because the shoe was lost.
Why was the shoe lost?
Because the nail was lost
Why was the nail of the shoe
lost?
.............................?
PCD-QSC-SOP-05
DIFFERENT TYPES OF NON CONFORMITY
IDENTIFIED IN CPD ACTIVITIES
• NON CONFORIMITY RELATED TO PROJECT
PROCURED MATERIAL.
• NON CONFORMITY RELATED TO SERVICE
CONTRACT DEVIATIONS.
• NON CONFORMITY RELATED TO END USER
(CUSTOMER)COMPLAINTS.
BS EN ISO 9001:2008
8.5.2 Corrective action
The organization shall take action to eliminate the causes of
nonconformities in order to prevent recurrence.
Corrective actions shall be appropriate to the effects of the
nonconformities encountered.
A documented procedure shall be established to define
requirements for
a) reviewing nonconformities (including customer complaints),
b) determining the causes of nonconformities,
c) evaluating the need for action to ensure that nonconformities do
not recur,
d) determining and implementing action needed,
e) records of the results of action taken , and
f) reviewing the effectiveness of the corrective action taken.
BS EN ISO 9001:2008
8.5.3 Preventive action
The organization shall determine action to eliminate the causes of
potential nonconformities in order to prevent their occurrence.
Preventive actions shall be appropriate to the effects of the
potential problems.
A documented procedure shall be established to define
requirements for
a) determining potential nonconformities and their causes,
b) evaluating the need for action to prevent occurrence of
nonconformities,
c) determining and implementing action needed,
d) records of results of action taken , and
e) reviewing the effectiveness of the preventive action taken.
Root Cause Analysis
Difficulties in tracking down the root causes
Where do you draw the line?
At the Joint Venture?
At the Parent Company?
At the Client?
At the Regulator?
At the Big Bang – creation of the universe?
What are the stop rules?
There are no natural break-points, only artificially imposed ones.
The goal is to establish what happened and how to stop it
happening again.
The logical stop point would seem to be where managers might
reasonably be expected to exercise control
A sad story will help to illustrate this point
What was supposed to happen?
• ________________________
• ________________________
• ________________________
• ________________________
• ________________________
• ________________________
Why was there a difference?
• ________________________
• ________________________
• ________________________
• ________________________
• ________________________
• ________________________
What actually happened?
(and did we get hurt?)
• ________________________
• ________________________
• ________________________
•________________________
• ________________________
• ________________________
What have we learnt?
Plus actions
• ________________________
• ________________________
• ________________________
• ________________________
• ________________________
• ________________________
Root Cause Analysis
I will not close out the NCR if the
evidence is not provided or the
action to prevent recurrence is
not adequate.
Closure Approval:
Closure:
The Closure must be completed
in full With all the evidence.
THANK YOU

More Related Content

What's hot

CAPA Training Presentation
CAPA Training PresentationCAPA Training Presentation
CAPA Training PresentationNancy Watts
 
Auditing Manufacturing Process and Product and Process Information.pdf
Auditing Manufacturing Process and Product and Process Information.pdfAuditing Manufacturing Process and Product and Process Information.pdf
Auditing Manufacturing Process and Product and Process Information.pdfDr. Dinesh Mehta
 
ISO 9001 2015 Overview presentation
ISO 9001 2015 Overview presentation ISO 9001 2015 Overview presentation
ISO 9001 2015 Overview presentation Govind Ramu
 
corrective and preventive action (CAPA)
corrective and preventive action (CAPA)corrective and preventive action (CAPA)
corrective and preventive action (CAPA)prakhar rai pk
 
Internal Audit 03-03-16
Internal Audit 03-03-16Internal Audit 03-03-16
Internal Audit 03-03-16Lisa Barnes
 
Root cause analysis
Root cause analysisRoot cause analysis
Root cause analysisSimmy Sharma
 
Quality Management System PowerPoint Presentation Slides
Quality Management System PowerPoint Presentation Slides Quality Management System PowerPoint Presentation Slides
Quality Management System PowerPoint Presentation Slides SlideTeam
 
Deviation, OOS & complaint investigation and CAPA
Deviation, OOS & complaint investigation and CAPADeviation, OOS & complaint investigation and CAPA
Deviation, OOS & complaint investigation and CAPADr. Amsavel A
 
Quality Management System awareness for all
Quality Management System awareness for all Quality Management System awareness for all
Quality Management System awareness for all ANUPAM RAY
 
Good Documentation Practice
Good Documentation PracticeGood Documentation Practice
Good Documentation PracticeDr. Amsavel A
 
Quality awareness
Quality awarenessQuality awareness
Quality awarenesssmcci
 
Corrective & Preventive actions (CAPA)
Corrective & Preventive actions (CAPA)Corrective & Preventive actions (CAPA)
Corrective & Preventive actions (CAPA)Yash Menghani
 

What's hot (20)

CAPA Training Presentation
CAPA Training PresentationCAPA Training Presentation
CAPA Training Presentation
 
Auditing Manufacturing Process and Product and Process Information.pdf
Auditing Manufacturing Process and Product and Process Information.pdfAuditing Manufacturing Process and Product and Process Information.pdf
Auditing Manufacturing Process and Product and Process Information.pdf
 
Internal audit training
Internal audit trainingInternal audit training
Internal audit training
 
Quality Management System
Quality Management SystemQuality Management System
Quality Management System
 
ISO 9001 2015 Overview presentation
ISO 9001 2015 Overview presentation ISO 9001 2015 Overview presentation
ISO 9001 2015 Overview presentation
 
corrective and preventive action (CAPA)
corrective and preventive action (CAPA)corrective and preventive action (CAPA)
corrective and preventive action (CAPA)
 
8D analysis presentation
8D analysis presentation8D analysis presentation
8D analysis presentation
 
Quality inspection presentation
Quality inspection presentationQuality inspection presentation
Quality inspection presentation
 
Internal Audit 03-03-16
Internal Audit 03-03-16Internal Audit 03-03-16
Internal Audit 03-03-16
 
Quality assurance
Quality assuranceQuality assurance
Quality assurance
 
Root cause analysis
Root cause analysisRoot cause analysis
Root cause analysis
 
Quality Management System PowerPoint Presentation Slides
Quality Management System PowerPoint Presentation Slides Quality Management System PowerPoint Presentation Slides
Quality Management System PowerPoint Presentation Slides
 
Deviation, OOS & complaint investigation and CAPA
Deviation, OOS & complaint investigation and CAPADeviation, OOS & complaint investigation and CAPA
Deviation, OOS & complaint investigation and CAPA
 
Quality Management System awareness for all
Quality Management System awareness for all Quality Management System awareness for all
Quality Management System awareness for all
 
Root cause analysis
Root cause analysisRoot cause analysis
Root cause analysis
 
Internal auditor 9001 day 1
Internal auditor 9001 day 1Internal auditor 9001 day 1
Internal auditor 9001 day 1
 
Good Documentation Practice
Good Documentation PracticeGood Documentation Practice
Good Documentation Practice
 
Basics of FDA GMP Training
Basics of FDA GMP TrainingBasics of FDA GMP Training
Basics of FDA GMP Training
 
Quality awareness
Quality awarenessQuality awareness
Quality awareness
 
Corrective & Preventive actions (CAPA)
Corrective & Preventive actions (CAPA)Corrective & Preventive actions (CAPA)
Corrective & Preventive actions (CAPA)
 

Viewers also liked

In-Tolerance Non-Conformance Investigations Webinar Slides
In-Tolerance Non-Conformance Investigations Webinar SlidesIn-Tolerance Non-Conformance Investigations Webinar Slides
In-Tolerance Non-Conformance Investigations Webinar SlidesTranscat
 
NCR Guidelines
NCR GuidelinesNCR Guidelines
NCR Guidelinescubisol
 
Changing the tires on a big data racecar
Changing the tires on a big data racecarChanging the tires on a big data racecar
Changing the tires on a big data racecarDavid McNelis
 
Mirik healthfoods pharma division
Mirik healthfoods pharma divisionMirik healthfoods pharma division
Mirik healthfoods pharma divisionmirikhealthfood
 
SSIF Performance Update for Investment Committee - FY2015
SSIF Performance Update for Investment Committee - FY2015SSIF Performance Update for Investment Committee - FY2015
SSIF Performance Update for Investment Committee - FY2015Greg Poapst
 
Cuestionario enologia 2
Cuestionario enologia 2Cuestionario enologia 2
Cuestionario enologia 2Lore Espinosa
 
Pm0017 project quality management
Pm0017 project quality managementPm0017 project quality management
Pm0017 project quality managementconsult4solutions
 
Ellis Course Work
Ellis Course Work Ellis Course Work
Ellis Course Work blundenellis
 
Mu0010 manpower planning and resourcing
Mu0010 manpower planning and resourcingMu0010 manpower planning and resourcing
Mu0010 manpower planning and resourcingconsult4solutions
 
Home Lighting Bathroom Fixtures
Home Lighting Bathroom FixturesHome Lighting Bathroom Fixtures
Home Lighting Bathroom FixturesConcept Lighting
 

Viewers also liked (18)

Ncr tutorials
Ncr tutorialsNcr tutorials
Ncr tutorials
 
In-Tolerance Non-Conformance Investigations Webinar Slides
In-Tolerance Non-Conformance Investigations Webinar SlidesIn-Tolerance Non-Conformance Investigations Webinar Slides
In-Tolerance Non-Conformance Investigations Webinar Slides
 
NCR Guidelines
NCR GuidelinesNCR Guidelines
NCR Guidelines
 
Changing the tires on a big data racecar
Changing the tires on a big data racecarChanging the tires on a big data racecar
Changing the tires on a big data racecar
 
İnovatif Kimya Dergisi Sayı-15
İnovatif Kimya Dergisi Sayı-15İnovatif Kimya Dergisi Sayı-15
İnovatif Kimya Dergisi Sayı-15
 
ADA 3 Slideshare
ADA 3 SlideshareADA 3 Slideshare
ADA 3 Slideshare
 
Mirik healthfoods pharma division
Mirik healthfoods pharma divisionMirik healthfoods pharma division
Mirik healthfoods pharma division
 
SSIF Performance Update for Investment Committee - FY2015
SSIF Performance Update for Investment Committee - FY2015SSIF Performance Update for Investment Committee - FY2015
SSIF Performance Update for Investment Committee - FY2015
 
Cuestionario enologia 2
Cuestionario enologia 2Cuestionario enologia 2
Cuestionario enologia 2
 
New budget
New budgetNew budget
New budget
 
Pm0017 project quality management
Pm0017 project quality managementPm0017 project quality management
Pm0017 project quality management
 
урок подорож
урок подорожурок подорож
урок подорож
 
Ellis Course Work
Ellis Course Work Ellis Course Work
Ellis Course Work
 
Mu0010 manpower planning and resourcing
Mu0010 manpower planning and resourcingMu0010 manpower planning and resourcing
Mu0010 manpower planning and resourcing
 
İnovatif Kimya Dergisi Sayı-18
İnovatif Kimya Dergisi Sayı-18İnovatif Kimya Dergisi Sayı-18
İnovatif Kimya Dergisi Sayı-18
 
USCCB
USCCBUSCCB
USCCB
 
Home Lighting Bathroom Fixtures
Home Lighting Bathroom FixturesHome Lighting Bathroom Fixtures
Home Lighting Bathroom Fixtures
 
Skth 0031
Skth 0031Skth 0031
Skth 0031
 

Similar to NON CONFORMANCE REPORTING (1)

Gap Analysis | GMP | By Industry Experts
Gap Analysis | GMP | By Industry ExpertsGap Analysis | GMP | By Industry Experts
Gap Analysis | GMP | By Industry Expertshimalya sharma
 
Quality control and quality managment philosophies by Prof.Saurabh S. Bhange
Quality control and quality managment philosophies by Prof.Saurabh S. BhangeQuality control and quality managment philosophies by Prof.Saurabh S. Bhange
Quality control and quality managment philosophies by Prof.Saurabh S. BhangeSaurabh Bhange
 
Smu mba sem 4 om spring 2016 assignments
Smu mba sem 4 om spring 2016 assignmentsSmu mba sem 4 om spring 2016 assignments
Smu mba sem 4 om spring 2016 assignmentssolved_assignments
 
PFMEA, Risk Reduction and Effectiveness – Advance (AIAG FMEA #4 Edition)
PFMEA, Risk Reduction and Effectiveness – Advance (AIAG FMEA #4 Edition)PFMEA, Risk Reduction and Effectiveness – Advance (AIAG FMEA #4 Edition)
PFMEA, Risk Reduction and Effectiveness – Advance (AIAG FMEA #4 Edition)Prashant Rasekar
 
Breakout_-_NCR_writing_and_closure.ppt
Breakout_-_NCR_writing_and_closure.pptBreakout_-_NCR_writing_and_closure.ppt
Breakout_-_NCR_writing_and_closure.pptValentinoDhiyu1
 
Auditing of quality assurance and maintenance of engineering department
Auditing of quality assurance and   maintenance of engineering departmentAuditing of quality assurance and   maintenance of engineering department
Auditing of quality assurance and maintenance of engineering departmentPriyanka Kandhare
 
Gap Analysis | QMS | By Industry Experts
Gap Analysis | QMS | By Industry ExpertsGap Analysis | QMS | By Industry Experts
Gap Analysis | QMS | By Industry Expertshimalya sharma
 
1.8.0 SITTNER CONOCO TRAIN HOW TO SURVIVE AN AUDIT
1.8.0 SITTNER CONOCO TRAIN HOW TO SURVIVE AN AUDIT1.8.0 SITTNER CONOCO TRAIN HOW TO SURVIVE AN AUDIT
1.8.0 SITTNER CONOCO TRAIN HOW TO SURVIVE AN AUDITSCOTT SITTNER
 
Non confirming product according to food Authority
Non confirming product according to food AuthorityNon confirming product according to food Authority
Non confirming product according to food AuthoritySuperior University
 
Calibration as a risk management strategy
Calibration as a risk management strategyCalibration as a risk management strategy
Calibration as a risk management strategyAlliance Calibration
 
Gap Analysis | ISO 9001 | By Industry Experts
Gap Analysis | ISO 9001 | By Industry ExpertsGap Analysis | ISO 9001 | By Industry Experts
Gap Analysis | ISO 9001 | By Industry Expertshimalya sharma
 
AUDITING OF QUALITY ASSURANCE AND ENGINEERING DEPARTMENT.pptx
AUDITING OF QUALITY ASSURANCE AND ENGINEERING DEPARTMENT.pptxAUDITING OF QUALITY ASSURANCE AND ENGINEERING DEPARTMENT.pptx
AUDITING OF QUALITY ASSURANCE AND ENGINEERING DEPARTMENT.pptxShankar Maind Patil
 
Driving Ambiguities Out of Requirements through Stronger Elicitation Techniques
Driving Ambiguities Out of Requirements through Stronger Elicitation TechniquesDriving Ambiguities Out of Requirements through Stronger Elicitation Techniques
Driving Ambiguities Out of Requirements through Stronger Elicitation TechniquesSusan Schanta
 
Quality Management System ISO 9001 Interpretation and Internal Audit
Quality Management System ISO 9001 Interpretation and Internal AuditQuality Management System ISO 9001 Interpretation and Internal Audit
Quality Management System ISO 9001 Interpretation and Internal AuditDinar Surtikarani
 
Six Sigma - 2. Perché utilizzarlo?
Six Sigma - 2. Perché utilizzarlo?Six Sigma - 2. Perché utilizzarlo?
Six Sigma - 2. Perché utilizzarlo?Manager.it
 
Sample sem 2 spring 2015
Sample sem 2 spring 2015Sample sem 2 spring 2015
Sample sem 2 spring 2015Tushar Ahuja
 

Similar to NON CONFORMANCE REPORTING (1) (20)

Gap Analysis | GMP | By Industry Experts
Gap Analysis | GMP | By Industry ExpertsGap Analysis | GMP | By Industry Experts
Gap Analysis | GMP | By Industry Experts
 
Quality control and quality managment philosophies by Prof.Saurabh S. Bhange
Quality control and quality managment philosophies by Prof.Saurabh S. BhangeQuality control and quality managment philosophies by Prof.Saurabh S. Bhange
Quality control and quality managment philosophies by Prof.Saurabh S. Bhange
 
Smu mba sem 4 om spring 2016 assignments
Smu mba sem 4 om spring 2016 assignmentsSmu mba sem 4 om spring 2016 assignments
Smu mba sem 4 om spring 2016 assignments
 
PFMEA, Risk Reduction and Effectiveness – Advance (AIAG FMEA #4 Edition)
PFMEA, Risk Reduction and Effectiveness – Advance (AIAG FMEA #4 Edition)PFMEA, Risk Reduction and Effectiveness – Advance (AIAG FMEA #4 Edition)
PFMEA, Risk Reduction and Effectiveness – Advance (AIAG FMEA #4 Edition)
 
Breakout_-_NCR_writing_and_closure.ppt
Breakout_-_NCR_writing_and_closure.pptBreakout_-_NCR_writing_and_closure.ppt
Breakout_-_NCR_writing_and_closure.ppt
 
IMPROVE CYCLE TIME BY REDUCING COST OF QUALITY (COQ) INDEX
IMPROVE CYCLE TIME BY REDUCING COST OF QUALITY (COQ) INDEXIMPROVE CYCLE TIME BY REDUCING COST OF QUALITY (COQ) INDEX
IMPROVE CYCLE TIME BY REDUCING COST OF QUALITY (COQ) INDEX
 
Auditing of quality assurance and maintenance of engineering department
Auditing of quality assurance and   maintenance of engineering departmentAuditing of quality assurance and   maintenance of engineering department
Auditing of quality assurance and maintenance of engineering department
 
Gap Analysis | QMS | By Industry Experts
Gap Analysis | QMS | By Industry ExpertsGap Analysis | QMS | By Industry Experts
Gap Analysis | QMS | By Industry Experts
 
08 project quality management
08 project quality management08 project quality management
08 project quality management
 
1.8.0 SITTNER CONOCO TRAIN HOW TO SURVIVE AN AUDIT
1.8.0 SITTNER CONOCO TRAIN HOW TO SURVIVE AN AUDIT1.8.0 SITTNER CONOCO TRAIN HOW TO SURVIVE AN AUDIT
1.8.0 SITTNER CONOCO TRAIN HOW TO SURVIVE AN AUDIT
 
Qsm guidelines
Qsm guidelinesQsm guidelines
Qsm guidelines
 
Non confirming product according to food Authority
Non confirming product according to food AuthorityNon confirming product according to food Authority
Non confirming product according to food Authority
 
Calibration as a risk management strategy
Calibration as a risk management strategyCalibration as a risk management strategy
Calibration as a risk management strategy
 
Gap Analysis | ISO 9001 | By Industry Experts
Gap Analysis | ISO 9001 | By Industry ExpertsGap Analysis | ISO 9001 | By Industry Experts
Gap Analysis | ISO 9001 | By Industry Experts
 
AUDITING OF QUALITY ASSURANCE AND ENGINEERING DEPARTMENT.pptx
AUDITING OF QUALITY ASSURANCE AND ENGINEERING DEPARTMENT.pptxAUDITING OF QUALITY ASSURANCE AND ENGINEERING DEPARTMENT.pptx
AUDITING OF QUALITY ASSURANCE AND ENGINEERING DEPARTMENT.pptx
 
Driving Ambiguities Out of Requirements through Stronger Elicitation Techniques
Driving Ambiguities Out of Requirements through Stronger Elicitation TechniquesDriving Ambiguities Out of Requirements through Stronger Elicitation Techniques
Driving Ambiguities Out of Requirements through Stronger Elicitation Techniques
 
Understand SPC Fundamentals
Understand SPC FundamentalsUnderstand SPC Fundamentals
Understand SPC Fundamentals
 
Quality Management System ISO 9001 Interpretation and Internal Audit
Quality Management System ISO 9001 Interpretation and Internal AuditQuality Management System ISO 9001 Interpretation and Internal Audit
Quality Management System ISO 9001 Interpretation and Internal Audit
 
Six Sigma - 2. Perché utilizzarlo?
Six Sigma - 2. Perché utilizzarlo?Six Sigma - 2. Perché utilizzarlo?
Six Sigma - 2. Perché utilizzarlo?
 
Sample sem 2 spring 2015
Sample sem 2 spring 2015Sample sem 2 spring 2015
Sample sem 2 spring 2015
 

NON CONFORMANCE REPORTING (1)

  • 2. WHAT IS AN NCR ? • A report issued when a product, process or procedure does not comply with the set standards for a product, process or procedure under inspection. • An NCR is any significant deficiency. • A means of tracking actions. • A tool to put right things that are going wrong. • A means of stopping repeated errors.
  • 3. WHAT IS AN NCR ? • NCR’s are used to record findings from internal and external audits that require addressing. • Work that was not built as indicated in approved drawings • Work that fails to meet specified tolerances as established in project specifications.
  • 4. WHAT IS AN NCR ? • Work that is being performed using non- approved methods or standards • When the testing and inspection plan is not followed as agreed • When testing results demonstrate that the product does not meet established and approved standards • When a material is used and has not been approved as a substitute (equal or similar)
  • 5. When design is not accurate and does not represents actual field conditions When the approved procedure was not followed and quality defects have been identify by the project team.
  • 6. THE IMPORTANCE OF NON CONFORMANCE REPORTING
  • 7. For want of a nail a shoe was lost, for want of a shoe a horse was lost, for want of a horse a rider was lost, for want of a rider an army was lost, for want of an army a battle was lost, for want of a battle the war was lost, for want of the war the kingdom was lost, And all for the want of a little horseshoe nail.
  • 9. Why was the Kingdom lost? Because the war was lost. Why was the war lost? Because the battle was lost. Why was the battle lost? Because the army was lost. Why was the army lost? Because the rider was lost.
  • 10. Why was the rider lost? Because the horse was lost. Why was the horse lost? Because the shoe was lost. Why was the shoe lost? Because the nail was lost Why was the nail of the shoe lost? .............................?
  • 11. PCD-QSC-SOP-05 DIFFERENT TYPES OF NON CONFORMITY IDENTIFIED IN CPD ACTIVITIES • NON CONFORIMITY RELATED TO PROJECT PROCURED MATERIAL. • NON CONFORMITY RELATED TO SERVICE CONTRACT DEVIATIONS. • NON CONFORMITY RELATED TO END USER (CUSTOMER)COMPLAINTS.
  • 12.
  • 13.
  • 14. BS EN ISO 9001:2008 8.5.2 Corrective action The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered. A documented procedure shall be established to define requirements for a) reviewing nonconformities (including customer complaints), b) determining the causes of nonconformities, c) evaluating the need for action to ensure that nonconformities do not recur, d) determining and implementing action needed, e) records of the results of action taken , and f) reviewing the effectiveness of the corrective action taken.
  • 15. BS EN ISO 9001:2008 8.5.3 Preventive action The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems. A documented procedure shall be established to define requirements for a) determining potential nonconformities and their causes, b) evaluating the need for action to prevent occurrence of nonconformities, c) determining and implementing action needed, d) records of results of action taken , and e) reviewing the effectiveness of the preventive action taken.
  • 16. Root Cause Analysis Difficulties in tracking down the root causes Where do you draw the line? At the Joint Venture? At the Parent Company? At the Client? At the Regulator? At the Big Bang – creation of the universe? What are the stop rules? There are no natural break-points, only artificially imposed ones. The goal is to establish what happened and how to stop it happening again. The logical stop point would seem to be where managers might reasonably be expected to exercise control A sad story will help to illustrate this point
  • 17. What was supposed to happen? • ________________________ • ________________________ • ________________________ • ________________________ • ________________________ • ________________________ Why was there a difference? • ________________________ • ________________________ • ________________________ • ________________________ • ________________________ • ________________________ What actually happened? (and did we get hurt?) • ________________________ • ________________________ • ________________________ •________________________ • ________________________ • ________________________ What have we learnt? Plus actions • ________________________ • ________________________ • ________________________ • ________________________ • ________________________ • ________________________ Root Cause Analysis
  • 18. I will not close out the NCR if the evidence is not provided or the action to prevent recurrence is not adequate. Closure Approval: Closure: The Closure must be completed in full With all the evidence.