The difference between NCR vs. FRACAS (Failure reporting, analysis, and corrective action system)

S

snowpenguin

#1
What's the meanning of the 'Fault' in FRACAS? Does it contain the defect of a pruduct? And in my company it is needed to fill a Fault Notice Record while finding out a noconformance. In my opinion the relationship between 'Noconformance' and 'Fault' is just like cause to consequense. But now I am comfused. I am very appreciated if someone help me out of this!
 
Elsmar Forum Sponsor

Bev D

Heretical Statistician
Staff member
Super Moderator
#2
This may only be a language problem.
There is no complicated definition or meaning to the words.

The 'F' in FRACAS (Failure reporting, analysis, and corrective action system) actually stands for FAILURE. It has no connotation or meaning that implies cause. In this case, faliure means the effect of the cause. Other terms often used in place of Failure in FRACAS are Problem or Data, etc.

I cannot explain why your company uses the term 'fault' instead of nonconformance. You would have to ask them. People and organizations often assign words without regard to their true meaning...sad but true.

To make these definitions somewhat complicated, read the following. In the most generally accepted definition of the words in the quality and engineering sciences:

'Defect' is typically a static thing; a nonconformance to a specified geometric feature or physical property. So a crack is a defect if the material is suppposed to be crack free. Likewise a length that is suppopsed to be between .9 and 1.1 but is actually 1.2 is a defect. In some countries, the term defect has legal consequences. In the United States courts of law, a defect has legal liability consequences and most legally sensitive companies will preclude the use of the term defect substituting the term 'nonformance' or other more benign term.

'Failure' is a dynamic event and the result of a defect, IF the tolerances for the 'defect' were properly engineered. properly specified defects will always result eventuallly in a failure of some sort. (Some defects require a condition for failure to result in an actual failure. This is the classical stress/strength interaction...)

'Nonconformance' is typically an event or condition that does not conform - or comply - to a stated requirement or procedure. You can think of a nonconformance as equivelent to a defect.

HOWEVER, many companies and customers have their own definitions of these terms and you must check those sources first as they generally supercede any 'commonly accepted' definition. For example, some people define a nonconformance to a procedure as a failure to folllow the procedure.
 
Last edited:
#4
Hi Bev, I have heard that the usage of defect is sensitive in the US by another statistician. I am glad to see your exact same explanation about "defect". I have been looking for an evidence/ a material to support my arguments about not using the term defect and replacing that with non conformance. Could you please share if you have seen any Orders or Law statements that speaks the same context of defects? Thank you!
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#5
Not sure of where I may have read this, probably in a book related to the auto industry. I remember having a book that dealt with how to handle legal implications...but I left the book to a colleague when i left the auto industry. I have been advised by several lawyers that the use of the term defect can be construed negatively by the courts and that I should use the term non-conformance. Of course defect and defective have specific meanings in quality statistics that relate to the use of the Poisson or Binomial distributions so we are in a difficult spot.
 
Thread starter Similar threads Forum Replies Date
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R What's the major difference between Green Belt and Black Belt in term of training and project Six Sigma 3
T Difference between a subcontractor and a supplier ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
H Difference between Stainless Steel 316 ASTM F899 and ASTM A276 Other Medical Device Related Standards 2
A Exact terms for a plating failure and difference between rejection rate and failure rate Manufacturing and Related Processes 9
M Difference between MSA and MSE? General Measurement Device and Calibration Topics 1
G What is the difference between discrete and continuous variables? Problem Solving, Root Cause Fault and Failure Analysis 5
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
S Difference between EU-MDR Annex IX and the Annex-combo X&XI EU Medical Device Regulations 2
T ISO 17025:2017 Clause 4.2.2 - The difference between "be notified" and "be informed" ISO 17025 related Discussions 4
Jimmy123 What is the difference between Error Proofing and Controls? ISO/IATF 16949 - Control Plans FMEA and Control Plans 16
C IEC 60601-1-8, difference between table 4 and annex D IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A What is the difference between Basic UDI-DI and UDI-DI? EU Medical Device Regulations 5
Q What is the difference between AS9100D 9.3.2.f and 9.3.3.a AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 7
M Aluminum - What is the difference between 6061-T6 and 6061-T651 (both per ASTM B211)? Manufacturing and Related Processes 4
P What is the exact difference between Risk and Opportunity in context of ISO 27001? IEC 27001 - Information Security Management Systems (ISMS) 7
S Difference between Surface Finish (Ra) and Flatness (GD&T) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
O Air Flow - Which is the operational difference between LAF (vertical and horizontal) and RLAF? Manufacturing and Related Processes 2
S What the difference is between Stub Acme & Acme thread? Oil and Gas Industry Standards and Regulations 1
S DO 178B - What is the difference between review and verification? Federal Aviation Administration (FAA) Standards and Requirements 1
T The difference between SOP and Kaizen Standardization Lean in Manufacturing and Service Industries 2
K Difference between intended purpose and intended use of the device EU Medical Device Regulations 9
Q What is the difference between normal and licensed internal auditor? VDA Standards - Germany's Automotive Standards 9
J What is the difference between Process Variation and Tolerance? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
O Difference Between PFMEA & Control Plan FMEA and Control Plans 3
S Difference between an Advisory Notice (ISO 13485) and a Field Safety Notice? ISO 13485:2016 - Medical Device Quality Management Systems 3
T Difference between "data analysis" and "management review" ISO 13485:2016 - Medical Device Quality Management Systems 4
Q What is the difference between 7.4.1 (2008) and 8.4.1 (2015)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Difference between uncertainty and expanded uncertainty of measurement General Measurement Device and Calibration Topics 1
S EASA Part 145 - The difference between non-certifying staff and Certifying staff Federal Aviation Administration (FAA) Standards and Requirements 2
S The difference between a Medical Device Accessory and Component Canada Medical Device Regulations 2
S What is the difference between a service request and a complaint? ISO 13485:2016 - Medical Device Quality Management Systems 2
I What is the difference between OOS/OOT Imported Legacy Blogs 3
A Definition Difference between Quality System Procedure and Standard Operating Procedure (SOP) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
Q Difference between Monitor & Measurement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T QA vs. RA - The difference between QA and RA Coffee Break and Water Cooler Discussions 6
A Difference between Discrimination and Least Count IATF 16949 - Automotive Quality Systems Standard 2
K Difference between Medical Electrical Equipment and Medical Equipment System IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Usability Standard - The difference between IEC 60601-1-6 to IEC 62336 Human Factors and Ergonomics in Engineering 1
S What is the difference between Verification and Validation of Test Reports? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
A Difference between ISO 9001:2015 Clauses 8.1 and 8.5.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M IATF 16949 Cl. 8.4.2.2 vs 8.6.5 - Is there any difference between these clauses? IATF 16949 - Automotive Quality Systems Standard 7
C What is the difference between "Overall Risk" and "Risk"? (ISO 14971) ISO 14971 - Medical Device Risk Management 10
C The difference between a Critical Dimension vs. Critical Characteristic Misc. Quality Assurance and Business Systems Related Topics 2
A ISO 9001:2015 - The difference between 6.1.1b and 6.1.1d - IMHO, d) implies b) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Difference between requirement for 4.4.1a (inputs) and 4.4.1d (resources needed)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R The difference between Feasibility Assessment and Contract Review Contract Review Process 2
V Difference between Non-Conformance, Variance and Deviation ISO 13485:2016 - Medical Device Quality Management Systems 7
A Difference between Environmental Impact and Risk ISO 14001:2015 Specific Discussions 7
A Difference Between Complaints and Feedbacks in terms of Follow-Up Actions Needed Customer Complaints 3
Similar threads


















































Top Bottom