How to do a Root Cause Failure Analysis

[peter_traina]

Hi Peter

I am looking at the Corrective action plan you were so kind to show us

One question, - I will sound super stupid here, but what is omission??

isnt the description the same??


again , I am new to it, and even though we got registered 3 years ago, we never got any NC so I never had to deal with it before

In my understanding was- we get NC
next step is - containment - if there is any - to stop the bleeding
then it is corrective action that includes - root cause and corrective action
plan

Never heard of omission????

Moncia,

That is correct... Get NC, Stop bleeding, CA including Root Cause...

My word "Omission" is my stab at a Root Cause for a problem that was/is simply a "Whoops, I missed that" NC!!! Don't know of anyone that has all the Stds, Regs, Essential Reqs, etc., etc., etc. memorized???
So, I got a minor NC for failing to reference a document, and in another minor NC, I got whacked for putting the reference in the wrong place (different doc.)
So, my big question to all the "Old Timers" around here, is what is your Root Cause for "I missed it" or "I was Ignorant", or "It was an Ommission"?
Root Causes might be... "I'm Stupid", I can't afford the latest and greatest Revision of any given Standard, each time it comes out at $ [email protected]$#%.00 dollars, or I can't afford an army of people to stay current on every little document that we've ever referenced!!!!!

So, Men and Women with great wisdom, what shall be my Root Cause for these agregeous errors??! Anyone....anyone at all??

 

[Big Jim]

Hi Big Jim!

First, let me thank you publicly! Sounds as if you've literally written the book on this stuff!
Secondly, I should have explained myself more clearly when I started this ...sorry.
I am 25 yrs. into this business... know all about 5 Whys, 8D, Fishbone diagrams, Fault Tree, pareto, PFMEA etc., etc.
So, let me re-explain my question/problem...
The Auditor has given us minor nc's for documentation issues only... for example:

Description​

Clause/​

Annex​

Root Cause​

Planned Actions​

Due Date​

Responsibility​

NON-CONFORMITY
The process to ensure that devices are correctly classified is not effective.
REQUIREMENT [Annex IX, Section II]
Application of the classification rules shall be governed by the intended purpose of the devices.

If the device is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. Accessories are classified in their own right separately from the device with which they are used.
OBJECTIVE EVIDENCE
The Generator and associated accessories were not classified in their own right.
Annex IX, Section II
Omission:
.
Review and revise Essential Require :mg:ments (ER) documents for our products currently being sold in the EU and those pending approval for sale in the EU to reflect product and accessory classification (ER-1004; ER-1005; ER-1006; ER-1007; ER-1008).
Review and revise SOP-1010 titled ‘Essential Requirements and Technical Documentation’ procedure to include the requirements of Annex IX, Section II.
Review and revise SOP-1019 titled “Procedure for Compliance with the Regulatory Aspects of the MDD” to include the requirements of Annex IX, Section II.
Establish training record for appropriate personnel for document changes.
9/18/11
Regulatory/Quality
NON-CONFORMITY
The solutions adopted to fulfill the essential requirements are incomplete.
2.1 REQUIREMENT [Annex I, ER 4]
ER 4 states that the characteristics and performances are not affected during the lifetime of the device as indicated by the manufacturer. The product lifetime must be declared along with the rationale for its calculation.
OBJECTIVE EVIDENCE
The product lifetime was not defined, nor was any supporting documentation provided.

Article 3 Annex I



2.1 Contact contract manufacturer, and determine lifetime of RF Generator based on components/materials within the generator. Document lifetime and rationale within ‘product specification’ documents and reference lifetime in applicable ‘essential requirements’ (ER) documents.

9/18/11
Regulatory/Quality

2.2 REQUIREMENT [Annex I, ER 12.1a]
For devices which incorporate software…, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.
OBJECTIVE EVIDENCE
The manufacturer has not referenced any standards or procedures relating to software life-cycle processes.
Article 3 Annex I
Omission:
Did not reference an appropriate state of the art standard relating to software life-cycle processes established during the design process for the RF Generator.
2.2 Review standard ISO 62304:2006. Determine if existing RF Generator documentation requires additional action based on gap analysis. Review and revise as required the product specification PS-1002 titled ‘RF Generator Software Requirement’ specification to indicate reference to ISO 62304. Add reference that includes ISO 62304 to applicable ‘essential requirements’ (ER) documents. Review and revise existing document DOP-1024 titled ‘Software Development Life Cycle’ to indicate requirements of ISO 62304.
Establish training record for appropriate personnel as required.
9/18/11
Regulatory/Quality
The clinical data did not fully meet the requirements of Annex X in the following aspects:
NONCONFORMITY
The clinical evaluation process is inadequate
REQUIREMENT [Annex X, Section 1.1] ‘clinical evaluation’, where appropriate taking account of any relevant harmonized standards, must follow a defined and methodologically sound procedure based on:
Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where: -there is demonstration of equivalence of the device to the device to which the data relates, and – the data adequately demonstrate compliance with the relevant essential requirements…
OBJECTIVE EVIDENCE: The manufacturer has not provided evidence to demonstrate equivalence of the device to the device to which the data relates.
Annex I, 6a Annex X
Omission: Comparative device information was not summarized within established clinical evaluations performed.
Clinical Evaluation has been performed and documented most recently through nContact documents EXD-1171 and EXD-1175. Action is to add a table to one of these evaluations summarizing the design comparison information between nContact devices and competitor’s devices.
9/20/11
Regulatory/Quality

NONCONFORMITY
The user documentation does not fully support the claimed compliance with EN 60601-1-2
REQUIREMENT [EN 60601-1-2:2001 (clause 6.8.3.201)]
For all EQUIPMENT and SYSTEMS, the ACCOMPANYING DOCUMENTS shall include the following information: Table 201, Table 202, the applicable tables 203/205 or 204/206.
OBJECTIVE EVIDENCE
The accompanying documents did not include the tables of guidance and manufacturer’s declaration regarding electromagnetic emissions and immunity.

Annex I, ER2
Omission:
Some of the 60601-1-2 requirements for statements of electromagnetic emissions and immunity were incomplete in the RF Generator’s Operator’s Manual.
Review the requirements of EN60601-1-2:2001, Clause 6.8.3.201. Revise RF Generator Operator’s Manual LBL-1095 as required to include table of guidance and statements regarding electromagnetic emissions and immunity.

9/20/11
R&D and Quality

NONCONFORMITY
The labeling requirements have not been fully met
5.1 REQUIREMENT [Annex I, ER 13.3(a)] The device label must bear the name and address of the manufacturer.
OBJECTIVE EVIDENCE
The RF Generator Label does not include the address of the manufacturer.

5.2 REQUIREMENT [Annex I, ER13.6(p)] The Instructions for Use must contain…(the) degree of accuracy claimed for devices with measuring function.
OBJECTIVE EVIDENCE
The RF Generator IFU does not include the degree of accuracy of the power.

Article 3
Annex I, ER 13
Omission:
A separate label with address was not applied directly to RF Generator.









Omission:
The degree of accuracy stated in the product definition was not included in the IFU.
5.1 Add a label to the RF Generator indicating the nContact address. Revise internal build documents as required to reflect new label.









5.2 Revise the RF Generator Operator’s Manual LBL-1095 to indicate the degree of accuracy of the power output.

9/20/11
Quality and Regulatory


So, this is my Corrective Action Plan...and as you can see, most of the "Root Causes" are "Omission", as in, I Missed It! What do they want me to say or do?? Root Cause... pay more attention?? or Make certain that I have read the latest Rev.? Not always reasonable for a very small company (<30, with all mfg. contracted)

Thanks for the compliment!

I don't know if it can be found anywhere in a standard, but there is an attitude about cause that is pretty much a requirement from any certification body that I know of, and that is something based on a teaching of Edward Deming. Deming taught that it is never the fault of a person, it is always a fault with the system.

As a result, resolutions that say "human error" or anything that seems related to it, are not acceptable. Whenever you come up with a "human error" answer, you need to rethink it until you can figure out what failed in the system.

Someone once told me that it always boils down to a documentation issue or a training issue. I'm not sure it is always that simple, but that should get you off "human failure".

 

[Moncia]

Moncia,

That is correct... Get NC, Stop bleeding, CA including Root Cause...

My word "Omission" is my stab at a Root Cause for a problem that was/is simply a "Whoops, I missed that" NC!!! Don't know of anyone that has all the Stds, Regs, Essential Reqs, etc., etc., etc. memorized???
So, I got a minor NC for failing to reference a document, and in another minor NC, I got whacked for putting the reference in the wrong place (different doc.)
So, my big question to all the "Old Timers" around here, is what is your Root Cause for "I missed it" or "I was Ignorant", or "It was an Ommission"?
Root Causes might be... "I'm Stupid", I can't afford the latest and greatest Revision of any given Standard, each time it comes out at $ [email protected]$#%.00 dollars, or I can't afford an army of people to stay current on every little document that we've ever referenced!!!!!

So, Men and Women with great wisdom, what shall be my Root Cause for these agregeous errors??! Anyone....anyone at all??

2 of mine would also fall into "I am stupid" category

 

[peter_traina]

Thanks for the compliment!

I don't know if it can be found anywhere in a standard, but there is an attitude about cause that is pretty much a requirement from any certification body that I know of, and that is something based on a teaching of Edward Deming. Deming taught that it is never the fault of a person, it is always a fault with the system.

As a result, resolutions that say "human error" or anything that seems related to it, are not acceptable. Whenever you come up with a "human error" answer, you need to rethink it until you can figure out what failed in the system.

Someone once told me that it always boils down to a documentation issue or a training issue. I'm not sure it is always that simple, but that should get you off "human failure".

Hi All~

Well, Big Jim, as a Quality Professional, I couldn't agree more! Thank you and everyone else for their input!

That said, there are instances where the "root cause" is nothing more than an anomoly... fix it and move on. As a company, we should not be "creating" elabororate Root Cause Analysis' for MINOR Non-conformances with documentation, unless of course, it's a systemic problem...and that would be a MAJOR, not a minor.

Ok, so I submitted my Plan, had it rejected for the Minors listed above (no Root Cause Analysis'), and then I updated it by adding the word "Omission" (as in, "I accidently omitted it...") for the Root Cause, for all 5 NC's...and guess what...!!??
The Auditor accepted it! All is well!
Now I just follow up on the fix (CA), and I'm done! It took nearly 4 wks, countless hours of brainstorming, asking Why, phone calls and faxes back and forth w/ the Auditor, and blogging with you folks, and it all came down to one word..."Omission"!
Now ain't that somethin' ?!?!

 

[ashishmaggo08]

Re: Root Cause analysis

Dear Monica,

As i read your conversation you need to do the rrot cause analysis as per the why why analysis technique. it is really very easy to find out real cause of the problem. for getting exact cause of the problem you need to ask 4 time why then you will come with the cause.

thanks

ISO Std. Section : 8.5.2 Process : Corrective & Preventive Action
Type of Nonconformity : Major 0 (Special Audit Required)
Major 0
Minor 

Established nonconformity (Requirement, Nonconformity, Evidence):
Requirement: The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence.
A documented procedure shall be established to define requirements for a) reviewing nonconformities b) determining the causes of nonconformities.

Nonconformity: Sample audited: 1 Was incorrectly classified as preventive action instead of corrective.
2. Had incorrect statement of the problem
3. Had incorrect root cause.
Evidence: PA 7.4 dated 9/8/2010



and number 4
this one I fought him on for 2 hours
still dont agree
it should be left as it was - preventive

 

[Moncia]

Re: Root Cause analysis

but not that easy when you are coming up with stupid answers
hahahhahahha

 

[Moncia]

Re: Root Cause analysis

OK

almost done
got all he root causes
now, one of - I hope- few last question for the problem

I got super useful Corrective action plan from Peter - thanks once again !!!!!!!!!!!!!

when one of our corrective action will be ongoing employee training - simply some people here just dont own a computer and since our system is online - we need to make them comfortable using it (the NC was, employees did not know how to access it)

So, back to my question, when the action is a continuous training - we will created a yearly schedule - the Due Date for the plan will be "ongoing" or should we put the date of our next registrar's audit??/

what do you think guys???
thanks

 

[Chance]

Re: Root Cause analysis

So, back to my question, when the action is a continuous training - we will created a yearly schedule - the Due Date for the plan will be "ongoing" or should we put the date of our next registrar's audit??/

IMHO: You should do it what's best suit to your company needs not for the auditors. You can put yearly dates.. etc.

 

[Chance]

Re: Root Cause analysis

I got super useful Corrective action plan from Peter - thanks once again !!!!!!!!!!!!!

Monica,

We started using Apollo Root Cause Analysis. I am not trying to advertise it here but it seems better than 8D.

Other Covers here, please let me know what you think.

Foundations of Problem Solving : http://www.apollorca.com/training/foundations

 

[Moncia]

Re: Root Cause analysis

so can I just put "ongoing" into the due date box???
it will be ongoing