I assume you're referring to a KPI on the auditor's part. The CB does get extra $$ for non-conformances -- so there's that.
8D on Audit Non Conformance -- Incomplete Document
- Thread starter Golfman25
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Randy
Super Moderator
And there it is. I remember somewhere that ANAB was under a belief that unless a NC per audit day was identified it might not be up to par, maybe Sidney or someone else might have some insight, I've checked the ANAB rules and can't find it so it's just a guess. If it were a rule I know the beyond myself there would be others that wouldn't agree with it because of its diminishing objectivity & impartiality.
Randy
Super Moderator
Ideally it would be best to do it during the audit when identified and not at a closing where everyone and his brother not involved are there.
Do a certificate transfer, you don't have to put up with crap like that. I've done transfers just for that.
Back to the question at hand. It seems my CB wants both a correction and a corrective action. According to the Auditing Practices Group guidance (and I don't know how much weight they carry), there are times when both a correction and corrective action are not always appropriate and either/or may be sufficient on it's own. It also addresses evaluation of the need for comprehensive root cause analysis based on the nature of the findings and whether they appear to indicate a systemic failure.
If I do my correction -- add the boxes to the org chart I have part 1. The problem is when I do my root cause and 5 whys I get stopped at about why #3. Start with Problem: "assigning roles/responsibilities is not entirely effective."
Why 1: Org chart doesn't identify all roles i.e.; operators.
Why 2: Because those roles are identified in applicable procedures
Why 3: Because that is allowed by the standard (i.e.; org chart is not required).
Thus, no root cause because their is no non-conformance. This would seem a perfect application of the above guidance which indicates a correction would be all that is necessary. I am missing something. What am I missing? Thanks
If I do my correction -- add the boxes to the org chart I have part 1. The problem is when I do my root cause and 5 whys I get stopped at about why #3. Start with Problem: "assigning roles/responsibilities is not entirely effective."
Why 1: Org chart doesn't identify all roles i.e.; operators.
Why 2: Because those roles are identified in applicable procedures
Why 3: Because that is allowed by the standard (i.e.; org chart is not required).
Thus, no root cause because their is no non-conformance. This would seem a perfect application of the above guidance which indicates a correction would be all that is necessary. I am missing something. What am I missing? Thanks
Tagin
Trusted Information Resource
If you are going to accept this as an NC, then you can't really say 'root cause is that there is no NC', which is in effect what you are doing there.
Do you specify anywhere in your QMS how you handle 5.3? E.g., is there anywhere where you say that "Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization in the following way..."?
If not, then the absence of that text could be your root cause, and the corrective would be to implement such text. For the NC, you have the text refer to the org chart as the method used. Later on, after the NC is closed, you can update the text to refer to your desired method (referencing them in your process/procedure docs, etc.).
In writing such text, you'd probably also want to explicitly list how you handle sub-clauses a-e of 5.3.
I may have no choice. The truth hurts. They wrote the damn thing. They can do the work and update the finding.
As part of our "quality manual" we have a clause matrix that identifies where in our system each and every statement in the standard is addressed. For 5.3 we identify two places -- the org chart and relevant procedures. Maybe that is something I can work with. Thanks.
I want to write: based on the shared level of frustration and presentation... the "combative" adjective may not be wholly inappropriate.
Without "taking sides", I can believe that there are gaps in the organization's implementation of training/responsibility if the only things that exist are:
I work for a manufacturer where lots of people have the same job title, but the jobs each person can perform are based on training curricula that get assigned to individuals, and the training (curricula/assignments) for each employee are regularly reviewed for correctness. As a manager, I have the responsibility to assign necessary curricula to my direct reports; as an employee I have to make sure I have correct training and curricula for any job I am asked to do. Specifically: I have maintained training for certain jobs that are typically executed by people with a different job title. There are others with my job title that can't do those jobs. Additionally, the WI (and curricula) are required to be regularly reviewed. This approach also allows us to avoid the perception that somehow people higher in an organizational hierarchy can successfully execute 100% of all the WI for the people that report to them: We explicitly use the (A)ccountable (I)nformed (R)esponsible model for curricula assignments.
Perhaps the auditor wrote the observation/finding in a way that is less than helpful, perhaps it is plainly wrong. I suggest that the root cause shouldn't be "an auditor gave a us a finding", even if this is how it is perceived.... as this is going to be a very poorly implement CA.
Without "taking sides", I can believe that there are gaps in the organization's implementation of training/responsibility if the only things that exist are:
- Work Instructions that call out job titles
- An org chart where all people have a job title
I work for a manufacturer where lots of people have the same job title, but the jobs each person can perform are based on training curricula that get assigned to individuals, and the training (curricula/assignments) for each employee are regularly reviewed for correctness. As a manager, I have the responsibility to assign necessary curricula to my direct reports; as an employee I have to make sure I have correct training and curricula for any job I am asked to do. Specifically: I have maintained training for certain jobs that are typically executed by people with a different job title. There are others with my job title that can't do those jobs. Additionally, the WI (and curricula) are required to be regularly reviewed. This approach also allows us to avoid the perception that somehow people higher in an organizational hierarchy can successfully execute 100% of all the WI for the people that report to them: We explicitly use the (A)ccountable (I)nformed (R)esponsible model for curricula assignments.
Perhaps the auditor wrote the observation/finding in a way that is less than helpful, perhaps it is plainly wrong. I suggest that the root cause shouldn't be "an auditor gave a us a finding", even if this is how it is perceived.... as this is going to be a very poorly implement CA.
Fair enough, but sounds like you come from a much larger organization. I have about 20 people, total. Most have been here 10+ years.
So what would you say the root cause is for the "ineffectiveness" of assignment of roles and responsibilities? From an audit standpoint, how can "effectiveness" be determined without a determination as to whether employees know their roles/responsibilities?
Personally: I am not a great fan of 5-Whys for problem solving... but even the adherents will recognize that there is no logical rationale regarding the number "5".
Obviously: the auditor should have issued the observation in such a way that the non-conformance should be well understood (by the CA team, by the org, by the third-party).
I don't work at the company, so what follows is speculation: Is it possible that the "root cause" is that titles on an org chart do not 100% align with job duties/responsibilities, such that for any given human with a specific job title there may not be evidence which demonstrates that human is trained to execute the job responsibility?
The argument that anyone with a given job title must be trained to do the assigned work doesn't pass the red-faced test for me, because if this was true a company ought to be able to make the case that no employee has to attest they did any work by name... they could simply write down their job title.
I don't want to propose action items to address this finding, but my guess is that (1) formally documenting specific training assigned to the humans, (2) updating the WI to indicate which training is specifically necessary to to execute any given WI, would be enough to erase any doubt that someone was ever trained, or trained at the time of execution. For a small company, I wouldn't expect you need to lean that hard into a training overhaul, but it doesn't seem unreasonable to document when individuals are qualified to execute certain WI.
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