An employee suggestion was received stating that if we did not document minor findings we could save the company +240 man hours to make those corrections.
What's your opinion? Should minor findings be written up for folks not following work instructions?

An employee suggestion was received stating that if we did not document minor findings we could save the company +240 man hours to make those corrections.
What's your opinion? Should minor findings be written up for folks not following work instructions?

The +240 hours, how was that determined?

In my opinion, if there is something that did not meet the requirements, it needs to be documented. If the finding isn't documented by the internal audit system it would most likely be documented during registration (if registered) audit.

An employee suggestion was received stating that if we did not document minor findings we could save the company +240 man hours to make those corrections.
What's your opinion? Should minor findings be written up for folks not following work instructions?

Dear Sir,
I feel that we should document all the findings however small the may appear. This is because it is very difficult to define what is small & what is a major NC. Most importantly once people get into the habit of not documenting the NCs, it is difficult to change.
The amount of money you will save by documenting the NCs, conducting root cause analysis, taking CAs & PAs, will be much more than the money/man hours you spend.
Major B V Naik

An employee suggestion was received stating that if we did not document minor findings we could save the company +240 man hours to make those corrections.
What's your opinion? Should minor findings be written up for folks not following work instructions?

I'll admit that we write up all findings, but we do word them in such a way to make them value-added to the organization and this includes considering the level of risk to the organization (i.e., what could potentially occur by deviating from the documented process).

How are your auditors writing up the findings? "People are not following the documented process?" Try this..."Documented process and actual practice do not match." This then takes the focus off of the people and has everyone asking why there has occurred. Yes, it could be people or, maybe the process has changed.

Essentially, rather than write up every single occurence, our auditors look to group the occurrences (if possible). If there is an apparently lack of adherence to the documented process within a department, the finding is written up as a Major issue, citing the individual examples as the evidence for justifying the level of the issue. This then requires root cause analysis by the recipient (go ahead and slap it on the Dept Manager's desk...get the big guy/gal involved!). Maybe people aren't following the document because it's wrong...maybe people have found a better way to do something but the document does not yet reflect this improved process with improved results. Let the recipient figure out WHY all of the little issues have added up to one biggie.

If you can not group the occurrences together, word the findings in such a way to highlight the level of risk to the organization. Imply environmental or safety repercussions...and if you aren't comfortable with writing the possible outcomes, ensuring that they are verbally explained in the closing meeting.

Another option to consider is that if you have so many occurrences of little deviations happening, it might be time for some data analysis which may spark "Recommendations for Improvement" to be discussed during your next Management Review. 240+ hours implies a few things...perhaps you have lots of deviations from the process or perhaps you have a lot of bad documents or perhaps your people aren't really fixing the issues (240 hours?!?! What the heck are they doing when they get this nonconformances?!?!)...time to delve a little deeper into the situation, my friend, and determine what is truly going on with your processes and documentation.

Should minor findings be written up for folks not following work instructions?If it is 'folks' plural, there is a problem. If it is one isolated incident, that's a whole different story.

If you find one person forgets to date a form once, for example, I wouldn't even write it up.
If one person does this many times, it's probably a training or discipline issue.
If many people do not complete documentation as required a corrective action investigation (Corrective action is the issue here) is warranted.

Write-ups do not take significant time. Corrective action investigations, typically, do take significant time.

An employee suggestion was received stating that if we did not document minor findings we could save the company +240 man hours to make those corrections.
What's your opinion? Should minor findings be written up for folks not following work instructions?

yes. not following work instructions is a non conformance. non conformances should be written up to show that you are monitoring the system.

but these write ups should address WHY the work instruction was not being followed in order to add value to the finding.
Is there a better way? Are the multiple acceptable ways? Is the process over documented such that there doesn't really need to be a work instruction? Is it simply laziness?

There shuold be a system to allow innovation. I've seen this done with a very simple deviation request that anyone can fill out and submit.
supervision then reviews the deviation and if it makes sense incorporates it into the process as acceptable practice.

An employee suggestion was received stating that if we did not document minor findings we could save the company +240 man hours to make those corrections.
What's your opinion? Should minor findings be written up for folks not following work instructions?

We're missing the point here. So, we know about the grading (and I've posted here many times that internal auditors shouldn't grade nc's, that's an external audit technique), but we don't know what's being written up as the content of the finding.

I can tell you from over 20 years experience of auditing and teaching auditing that being told "you're not following procedure/instruction" isn't a complete story. Management don't assume that the documentation is correct, and often it isn't. Therefore they only get confused and resentful of the findings, especially when the issue isn't on their 'radar screen'!!

In addition to the management response, auditors often forget to find out if the results the 'folks' get is any good, which is more to the point and is helpful in determining what to do to correct the situation.

It's a mantra auditors need to stop chanting. Get to the results of the process and be helpful to the 'folks', don't just give them half the story.......

Andy

PS I'm thinking you should take the employee with the suggestion and make them an internal auditor..........seriously(!)

An employee suggestion was received stating that if we did not document minor findings we could save the company +240 man hours to make those corrections.

What's your opinion? Should minor findings be written up for folks not following work instructions?

I am one to hold up the torch of employee involvement. But vocabulary such as the employee's suggestion is a dangerous combustible. Getting management on the path of saving money by reducing observations is the first nail in the coffin.

1. Are these minor findings coming from within (internal auditors)? If so, are they proficient enough in their training? Are they writing up the non-conformances appropriately?

2. If they are proficient and doing their job correctly, then your organization must have one mammoth quality system, with lengthy procedures around every corner.

3. If 1 and 2 are incorrect, you have management not enforcing the quality system. If they will change the culture and use the quality system, they will save a whole lot more than 240 man hours.

Write-ups do not take significant time. Corrective action investigations, typically, do take significant time.

For me this is the issue. All NCs should be written up, but only those that are repetitive, or that involve significant risk abd/or cost, etc. should require a formal corrective action investigation.

For me this is the issue. All NCs should be written up, but only those that are repetitive, or that involve significant risk abd/or cost, etc. should require a formal corrective action investigation.


You are incorrect in your assumption if you are performing QMS audits.

ISO 9001
8.5.2 Corrective action
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.

A NC means that something is broke. It's kinda like being a little bit pregnant.

Additionally the term FINDING is being used incorrectly. If you are going to be referencing something like ISO 19011 get the terms correct in their usage to help "folks" to understand the real issues.

ISO 19011:2002, Clause 3.4
audit findings
results of the evaluation of the collected audit evidence (3.3) against audit criteria (3.2)
NOTE Audit findings can indicate either conformity or nonconformity with audit criteria or opportunities for improvement.

Every small NC has the potential to become a big one. I'd also wager that NC's outnumber OFI's or PA's.

A NC means that something is broke. It's kinda like being a little bit pregnant.
Every small NC has the potential to become a big one. I'd also wager that NC's outnumber OFI's or PA's.

I agree! and a little bit pregnant is a good comparison.:lmao:

If you are talking about true system nonconformances, they need to be written up. if you are suggesting that I write up a nonconformance every time that I have to adjust a knob (within accepted parameters to keep the process in control) then no, those do not need to be written up.

An employee suggestion was received stating that if we did not document minor findings we could save the company +240 man hours to make those corrections.
What's your opinion? Should minor findings be written up for folks not following work instructions?Excellent idea of quantifying the savings. What about quantifying the costs associated (if any) of people not following work instructions? Is the lack of adherence to WI's leading to substandard products? If the lack of discipline is inconsequential, then you should question the value of having WI's in the first place.

You are incorrect in your assumption if you are performy QMS audits. ISO 90018.5.2 Corrective action The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.

But read on ... "Corrective actions shall be appropriate to the effects of the nonconformities encountered." So if the effect is negligible, why go to all the effort to initiate a CAR? Document the NC so it is available in case we find additional occurrences (e.g., during later audits) which might then indicate a need for CA.

But read on ... "Corrective actions shall be appropriate to the effects of the nonconformities encountered." So if the effect is negligible, why go to all the effort to initiate a CAR? Document the NC so it is available in case we find additional occurrences (e.g., during later audits) which might then indicate a need for CA.

Because, you can only determine whether or not a corrective action should be done if you first know about, and analyze the reason for the nonconformance? I'm sorry, but way too many people do not realize that there is a diffence between a corrective action (action that is planned and completed to eliminate the recurrence of a failure or nonconformance, based upon the seriousness, risk and financial gains and losses) and the actual identification of a problem (failure, nonconformance).

For someone to actually believe that it is better to not identify the nonconformance in the first place as a money saving method is unbelievable to me. On the other hand, for someone to think that every time you identify a problem you have to put the same amount of work and money into a fix, is equally idiotic. Do not throw a $20,000 fix at a $10 problem!

So if I understad correctly, every 'finding' or deviation from the documented process is a 'nonconformance'. Once we have identified a nonconformace, a CAR will always be created to determine the cause/origin of the deviation, regardless of the seriousness of the deviation. Only the seriousness of the nonconformance will determine the amount of time/effort needed to resolve the problem (close the CAR).

If this is true, is there any value or need for keeping 2 records, one for nonconformances and another for CARs generated from internal audits?

MtlGuy

So if I understad correctly, every 'finding' or deviation from the documented process is a 'nonconformance'. Once we have identified a nonconformace, a CAR will always be created to determine the cause/origin of the deviation, regardless of the seriousness of the deviation. Only the seriousness of the nonconformance will determine the amount of time/effort needed to resolve the problem (close the CAR).

If this is true, is there any value or need for keeping 2 records, one for nonconformances and another for CARs generated from internal audits?

MtlGuy

No, you're not right. :nope:

A "finding" is the end product of evaluating audit evidence against audit criteria.

A fiinding could be conformance, non-conformance, observation, OFI or whatever.

A non-conformance is the non-fulfillment of a requirement (deviation if you choose).

As for how they (NC's) are handled that is up to each individual organization to determine, but must be in line with the requirements of the particular management system. Here's what 9001 states in part...

8.5.2 Corrective action
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.

Does this mean that "all" NC's must be corrected? Well that's the expectation. A big question is "What organization would want to operate with full knowledge that something is broke and not try to fix it?" Is there a some expectation that the problem will be self correcting? I'm sorry, but when people ask "should I fix my flat tire?" while still expecting to be able to drive down the highway I have to say "DUH!"

I don't see a need for two records. I keep them on the same spreadsheet.

Audit report number
Area audited
NC number (each one gets its own row)
Comments
Date issued
Response due date
Response date
Short description of the NC
Short description of the action to be taken
Expected completion date
Project it's involved with, or "N"
Responsible person
Is it a simple document update? Y/N
Is it on track? Y/N
Reaudit date
Closure date

The cool thing about spreadsheets is that they can act like databases; the data can be sorted. You can have 10 years' worth of data and choose to only look at those not on track.

I've attached an example. A lot of the cells have been formatted to do things like turn colors when a due date is less than one week away, or late. That helps me prioritize.

Wow Jennifer, what a great/comprehensive spreadsheet. I will definitely try to create something similar for our organization using your spreadsheet as a base (althought modifying it slightly to reflect the ISO 13485:2003 standard), if that's ok.

I'm just curious, did you create this, or is there some wonderful repository of tools/spreadsheets/checklists available that I'm unaware of?

Thanks to both you and Randy for the prompt/informative responses.

You're welcome. Feel free to adapt as you need to.

The tracking log is a model we've used for a long time. In the last couple of month I've added the status, formatting and charting of response time.

The Audit Results workbook is a reworked version of a nice attachment that Crusader posted a few months ago. The ability to do that is just one very cool thing about The Cove. Maybe after you adapt it for ISO 13485(2003) maybe you can attach the result to share.

Check out the list of attachments here (http://elsmar.com/Forums/fileslist.php), do a search via the menu in the tool bar above (yellow text) or look through the threads by subject.

A non-conformance is the non-fulfillment of a requirement (deviation if you choose).

As for how they (NC's) are handled that is up to each individual organization to determine, but must be in line with the requirements of the particular management system. Here's what 9001 states in part...

8.5.2 Corrective action
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.

Does this mean that "all" NC's must be corrected? Well that's the expectation. A big question is "What organization would want to operate with full knowledge that something is broke and not try to fix it?" Is there a some expectation that the problem will be self correcting?


here in lies the dilemma concerning corrective for non-conformances detected during internal audits:

8.2.2 Internal audit
...The management responsible for the area being audited shall ensure that actions are taken without undue delay to
eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions
taken and the reporting of verification results (see 8.5.2).
From this I woudl interpret that all nonconformances regardless of severity of effect detected durign an audit woudl require Corrective Action as to Cause. (not merely remedial action). I guess we could debate the interpretation of a "nonconfomrance". Is the failure to fill out a single field of a single form by a single operator a nonconformance? if so, it's a CAR.

I don't think many of us would debate the flat tire thing, but many of us would debate the form thing...

here in lies the dilemma concerning corrective for non-conformances detected during internal audits:

8.2.2 Internal audit
...The management responsible for the area being audited shall ensure that actions are taken without undue delay to
eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions
taken and the reporting of verification results (see 8.5.2).
From this I woudl interpret that all nonconformances regardless of severity of effect detected durign an audit woudl require Corrective Action as to Cause. (not merely remedial action). I guess we could debate the interpretation of a "nonconfomrance". Is the failure to fill out a single field of a single form by a single operator a nonconformance? if so, it's a CAR.

I don't think many of us would debate the flat tire thing, but many of us would debate the form thing...


Well Bev that's all well and good, but read what I said..."there is an expectation of corrective action for all NC's" and yes, it is not stated that ALL must be actually be corrrected. So do this will ya. Knock a small hole in the oil pan of your car and drive around expecting your engine to continue to run as if everything was normal.

There is an old, old story about "For the want of a nail...." it has great truth within it.

Additionally, here's waht might be a revelation for some folks, the need for corrective action can come from reasons other than the audit.

yes Randy I understood your point. All NC's found in an internal audit require corrective action. and they require corrective action as to cause. My point was: what truly consititutes an NC? I know full well what happens when an oil pan gets a hole in it. that isn't the kind of NC I was referring to.

Is a single missed field in a single form by a single person really an NC? Should the auditor be looking for things that have a bigger affect on the organization?? and can they not write up the single trivial isolated event?

My point was: what truly consititutes an NC? I know full well what happens when an oil pan gets a hole in it. that isn't the kind of NC I was referring to.

Is a single missed field in a single form by a single person really an NC? Should the auditor be looking for things that have a bigger affect on the organization?? and can they not write up the single trivial isolated event?


Nonconformity = nonfulfillment of "a" requirement.

One form wrong out of a million meets the definition. Does the auditor issue one? What is the risk to customer satisfaction, to the environment or to peoples safety? (depends on management system being audited) One of the desired attributes of an auditor is to be decisive, so decide.

What the auditor looks for during an audit and how deep the auditor looks should be decided based upon the objectives, scope and criteria of the specific audit.

Randy, I agree with you (I know you might not like that!;) ) that any departure from requirements is an NC - by definition. It is the ability to apply judgement to the situation that makes the difference between auditors.

I regularly tell new auditors that the easiest thing to do is raise everything - that way there is no judgement required. The effect of doing so would be to tee everyone off and turn them against audits.

Look at the consequences and the impact of the NC that has been found and then decide. I believe it is OK to find an NC and not raise it if the consequences are not significant.