But if there is no policy....

Stop doing it, then B. The common sense approach would be the obvious solution for grown-ups, but won’t defend you against ambulance chasers/parents/arse coverers...
 
Part of this may depend on what you define as a policy. In the pharma industry a policy is the top document of the pyramid, what we use to call the 'motherhood and apple pie' document. We had one policy for a whole factory that essentially said we'd follow a specific ICH standard, which was in itself a pretty generic document. Statements like "The process will be validated" occur without the least clarification as to what this means. Below that you got ever more detailed layers of procedures and records that actually told you how do do it and where to write it down. there's also the ubiquitous phrase "to comply with local regulations" that avoids the need to rewrite everything when some civil servant moves a couple of commas around in the regulations because he's bored.
The first time I reviewed a primary care PPG file the opening document stated 'This Practice Shall Have a Policy for the Prescribing of Antibiotics'..............................that was it! To be fair, the development of quality management in UK healthcare (assurance in the US) was, with some exceptions in Surgery, Laboratory and Pharmacy, a procrastinated and uneven affair. By the time more UK physicians became aware of the evolution from the Hammurabi code to the more formal measurement and assessments of Shewart/Deeming/Juran the US JCAHCO had been up and running for some decades (c. 1951). While doctors were articulate in developing Clinical Protocols they were somewhat mystified when it came to the more administrative elements of PPG.s. It was an opportunity for me to roll my sleeves up and assist - and it was a most rewarding venture in terms of personal and professional development.
Much has changed (I think/hope), and I believe the intent is to retain the 'quality' function in all of its dimensions as an integral aspect of education and training within each of the clinical professions.
 
Thank you for the replies so far.

To spice things up a bit, consider that the management person who would have been responsible to implementing any such policy was aware of previous failings of other management types, and by doing nothing he did not have to tell of them.

How does that change the way things look?
Depends how brave one is feeling. I'd probably analyze the problem first, put the 'draft' analysis through option C) and see if anything from B) would be amenable to suitable modification. I'd write out the analysis & consequences element and, if a solution(options) had been found, add that (them), and then prepare for upward transmission. The outcome could be anything from, as @Fang_Farrier says, ringing a mate or having a quick google, up to a detailed service paper (or civvie equivalent).

The next step would depend upon what degree of control I had or was willing to assume. If I thought I could do something I either would, without reference to higher up the food chain, or I'd send my situation paper upward with an "I intend to ..." (or equivalent) clause, which would put the onus on a grown-up to stop me, and then go ahead if I heard nothing back.

If politics was going to be a real issue, I'd write the paper in such a way that I was a mere ignorant underling seeking advice from management ... and send an info copy sideways to somebody with a potential interest (eg, QA). Or play other such games - lots of places have change software-driven change processes these days that make it more difficult to avoid issues.

My preferred method was to seek forgiveness, not permission. Sometimes people were happy that a situation had just gone away, most of the time the higher-ups were more than capable of either working out a good defence for their previous inaction or taking the credit for a junior's initiative. Not always possible, though, and sometimes you've just got to move on, whilst leaving a paper trail behind you.

All a bit arm-wavy, I'm afraid, without a bit more detail.
 

Fang_Farrier

LE
Kit Reviewer
Book Reviewer
Part of this may depend on what you define as a policy. In the pharma industry a policy is the top document of the pyramid, what we use to call the 'motherhood and apple pie' document. We had one policy for a whole factory that essentially said we'd follow a specific ICH standard, which was in itself a pretty generic document. Statements like "The process will be validated" occur without the least clarification as to what this means. Below that you got ever more detailed layers of procedures and records that actually told you how do do it and where to write it down. there's also the ubiquitous phrase "to comply with local regulations" that avoids the need to rewrite everything when some civil servant moves a couple of commas around in the regulations because he's bored.
Many of our HR policies and procedures have the phrase "at manager's discretion" in them.

Unfortunately as a board we have just had a QC led investigationand subsequent report into bullying which oft mentions unfairly applying such policies and procedures!
 

Fang_Farrier

LE
Kit Reviewer
Book Reviewer
Depends how brave one is feeling. I'd probably analyze the problem first, put the 'draft' analysis through option C) and see if anything from B) would be amenable to suitable modification. I'd write out the analysis & consequences element and, if a solution(options) had been found, add that (them), and then prepare for upward transmission. The outcome could be anything from, as @Fang_Farrier says, ringing a mate or having a quick google, up to a detailed service paper (or civvie equivalent).

The next step would depend upon what degree of control I had or was willing to assume. If I thought I could do something I either would, without reference to higher up the food chain, or I'd send my situation paper upward with an "I intend to ..." (or equivalent) clause, which would put the onus on a grown-up to stop me, and then go ahead if I heard nothing back.

If politics was going to be a real issue, I'd write the paper in such a way that I was a mere ignorant underling seeking advice from management ... and send an info copy sideways to somebody with a potential interest (eg, QA). Or play other such games - lots of places have change software-driven change processes these days that make it more difficult to avoid issues.

My preferred method was to seek forgiveness, not permission. Sometimes people were happy that a situation had just gone away, most of the time the higher-ups were more than capable of either working out a good defence for their previous inaction or taking the credit for a junior's initiative. Not always possible, though, and sometimes you've just got to move on, whilst leaving a paper trail behind you.

All a bit arm-wavy, I'm afraid, without a bit more detail.
In my experience, the upper levels are often grateful for you to bring them the solution to the problem which they should have had in place in the first instance.
 
Sorry if this seems vague, but that is for a reason.

What do you think an organisation governed by rules should do if something happens that does not fit into the existing policies?

a) Do nothing.

b) Find the policy that is the closest match to the new situation, and amend it as required.

c) Deal with it using common sense, taking into account legal obligations and recommendations from a Subject Matter Expert.

d) Other.....?
d - other.
Send an email to the most senior person in your direct management chain. Explain that a situation has arisen for which there is no policy. Set out how you learned of the issue, why it hasn't been dealt with by predecessors, and the steps you've taken to ID policy; and the potential consequences of the issue not being dealt with.
To be proactive, offer to take forward action to develop a policy, or to speak to the relevant people.
This is a good approach as it lets your bosses know that you are conscientious, puts the issue and risks in their lap (making it a shared problem and not just yours) and gives you some control over how the issue is resolved.
 
Many of our HR policies and procedures have the phrase "at manager's discretion" in them.

Unfortunately as a board we have just had a QC led investigation and subsequent report into bullying which oft mentions unfairly applying such policies and procedures!
You don't get the word 'discretion' in a pharma SOP. "At managers discretion" is a loop hole made to be driven through so I'm not surprised that it's happened, or that whoever wrote it is now in the dock, possibly literally.
 
d - other.
Send an email to the most senior person in your direct management chain. Explain that a situation has arisen for which there is no policy. Set out how you learned of the issue, why it hasn't been dealt with by predecessors, and the steps you've taken to ID policy; and the potential consequences of the issue not being dealt with.
To be proactive, offer to take forward action to develop a policy, or to speak to the relevant people.
This is a good approach as it lets your bosses know that you are conscientious, puts the issue and risks in their lap (making it a shared problem and not just yours) and gives you some control over how the issue is resolved.
AKA do nothing but cover your arse.
 
AKA do nothing but cover your arse.
No. If you are working for an organisation with a chain of command of more than a few people, you need to highlight the issue, and get it dealt with formally. If you go ahead with a local solution, you may miss a flaw that will later undermine your solution; there may be wider policy or practice ramifications you are unaware of. Your local solution may have wider applicability, etc.
You can of course highlight the issue and propose a solution.
The dept. I work for recently had a similar situation. A security situation arose and there was no process in place. On the ground, we used common sense to solve the matter but then escalated the issue and our ideas for solving it.
 
No. If you are working for an organisation with a chain of command of more than a few people, you need to highlight the issue, and get it dealt with formally. If you go ahead with a local solution, you may miss a flaw that will later undermine your solution; there may be wider policy or practice ramifications you are unaware of. Your local solution may have wider applicability, etc.
You can of course highlight the issue and propose a solution.
The dept. I work for recently had a similar situation. A security situation arose and there was no process in place. On the ground, we used common sense to solve the matter but then escalated the issue and our ideas for solving it.
Your original post didn't say that, now it's a good way forward.
 
In my experience, the upper levels are often grateful for you to bring them the solution to the problem which they should have had in place in the first instance.
While any quality analysis and improvement program needs to be conceptually embedded within the 'upper levels', its execution must be operationally embedded at the lowest level of desired effect........otherwise it is doomed to failure.
Totally agree with the need to 'anslyse' the problem but this must involve those who actually carry out the various functions involved in related processes if the issues are to be properly identified, understood and improved.
ETA: Could I have a black coffee, one suger.....this is terribly early for a QC meeting.......:cool:
 
In most organisations, the preferred method is to drop it in the lap of the most junior of the senior staff or whoever is prepared to step up and deal with it, while preparing to take credit if it works or shit all over them if it doesn't.
 
Depends on where those management types are now, who signed what, and how they react to failure. If they're his bosses, have a habit of shooting messengers and their signatures are on the defective document then it may be expedient to keep quiet. Funnily in my experience that sort of person was often conveniently missing when the policy had to be signed and their deputy had to pp it for them, thus allowing them the luxury of playing Teflon™ shoulders if anything went wrong.
That’s why I never PP anything without some record that they are content with me to do so on their behalf - not ‘instead’ of them.
 
First IA drill should be to apply current policy where at all possible. This can expose potential problems like:

1. There’s no appropriate policy

2. There’s a ‘near fit’ but existing documentation doesn’t make it clear whose role it is to interpret existing policy.

If there’s no way to apply existing policy then it depends on urgency. If the benefit of ‘c’ outweighs the risk of winging it, then c, on the understanding that it need to be followed by ‘d’ (redrafting policy) unless this is a clear one off.

If there’s no urgency, straight to ‘d’.
 
Sorry if this seems vague, but that is for a reason.

What do you think an organisation governed by rules should do if something happens that does not fit into the existing policies?

a) Do nothing.

b) Find the policy that is the closest match to the new situation, and amend it as required.

c) Deal with it using common sense, taking into account legal obligations and recommendations from a Subject Matter Expert.

d) Other.....?
C is my approach and as the SME for everything I am beyond reprieve. Oh I forgot I am not @PhotEx
 

Yokel

LE
First IA drill should be to apply current policy where at all possible. This can expose potential problems like:

1. There’s no appropriate policy

2. There’s a ‘near fit’ but existing documentation doesn’t make it clear whose role it is to interpret existing policy.

If there’s no way to apply existing policy then it depends on urgency. If the benefit of ‘c’ outweighs the risk of winging it, then c, on the understanding that it need to be followed by ‘d’ (redrafting policy) unless this is a clear one off.

If there’s no urgency, straight to ‘d’.
First IA drill should be to apply current policy where at all possible. This can expose potential problems like:

1. There’s no appropriate policy

2. There’s a ‘near fit’ but existing documentation doesn’t make it clear whose role it is to interpret existing policy.

If there’s no way to apply existing policy then it depends on urgency. If the benefit of ‘c’ outweighs the risk of winging it, then c, on the understanding that it need to be followed by ‘d’ (redrafting policy) unless this is a clear one off.

If there’s no urgency, straight to ‘d’.
What about in a situation where option a - doing nothing - is likely to protect management reputations at the expense of the individual who has been treatment in ways not compliant with accepted norms and extant policy - and concealing the truth disadvantages that individual due to being excluded?
 
What about in a situation where option a - doing nothing - is likely to protect management reputations at the expense of the individual who has been treatment in ways not compliant with accepted norms and extant policy - and concealing the truth disadvantages that individual due to being excluded?
Then you’re f**ked.

The assumption of any policy/SOP/doctrine is that they will be applied. If someone at the top of the process goes off reservation there’s nothing to be done until someone above (or a regulator) pays attention.

Hence ‘whistleblowers’.
 
What about in a situation where option a - doing nothing - is likely to protect management reputations at the expense of the individual who has been treatment in ways not compliant with accepted norms and extant policy - and concealing the truth disadvantages that individual due to being excluded?
You mean like a "well-hung, 6' 6" person of male appearance and a basso profundo voice rocking up one day in high heels and a mini skirt, demanding to be known as Tiffany and making a fuss about not being allowed to use the female toilets despite policy saying the 'she' should" kind of way?

It depends entirely upon the organization. HR are supposed to deal with workforce exclusion issues, but if they're part of the problem ... Some companies have periodic management-workforce briefings and the subject could be raised there in front of a large audience, say by asking what the policy surrounding X is and then asking how management would react to an individual being treated like Y, then pounce (at the time or later).

Another possibility is to look at why the individual is excluded and trying to bridge that gap somehow (I had somebody working for me who had been badly overlooked for promotion and wage increases. I tend to believe 97% of problems are training related so trained him, made a fuss up the line and got him to the level he should have been at; he shouldn't have been treated in the way he was at all, but that was all glossed over; didn't care, I got what he wanted out of it)
 
What about in a situation where option a - doing nothing - is likely to protect management reputations at the expense of the individual who has been treatment in ways not compliant with accepted norms and extant policy - and concealing the truth disadvantages that individual due to being excluded?
You are not 'fecked', but you would be getting 'fecked'. The solution, the only solution, is the collection of evidence, overtly or covertly.

The first piece is/are the organizations 'extant policy(ies); the second is the expression of 'accepted norms' which may be revealed through case examples that show the precedence of alternative 'treatments' within the same or comparable circumstances. A third evidential element is the existence of industry applicable regulations including, but not limited to HR and H&S. A fourth possibility is 'statutory' rules.

You need to be able to show that 'treatment' is outwith "accepted norms' by defining what those norms are, how they come to be 'accepted', by whom (e.g., they could be 'informal', but reasonably represent the expectatio s within the workforce and or 'industry'). You then need to provide evidence of breach of policy (organizational, industrial or statutory).......any such breach(es) are likely to also constitute a breach of contract. Other documentation that will be needed are therefore a copy of the Contract of Employment (Legally required to be given to an employee), a copy of an Employee Job Description (which should be consistent with any applicable organizational, industrial or statutory policies and procedures) and a copy of any performance reviews conducted by a designated supervisor (who has demonstrable competence in conducting such a review).

No, not 'fecked at all.
 
You are not 'fecked', but you would be getting 'fecked'. The solution, the only solution, is the collection of evidence, overtly or covertly.

The first piece is/are the organizations 'extant policy(ies); the second is the expression of 'accepted norms' which may be revealed through case examples that show the precedence of alternative 'treatments' within the same or comparable circumstances. A third evidential element is the existence of industry applicable regulations including, but not limited to HR and H&S. A fourth possibility is 'statutory' rules.

You need to be able to show that 'treatment' is outwith "accepted norms' by defining what those norms are, how they come to be 'accepted', by whom (e.g., they could be 'informal', but reasonably represent the expectatio s within the workforce and or 'industry'). You then need to provide evidence of breach of policy (organizational, industrial or statutory).......any such breach(es) are likely to also constitute a breach of contract. Other documentation that will be needed are therefore a copy of the Contract of Employment (Legally required to be given to an employee), a copy of an Employee Job Description (which should be consistent with any applicable organizational, industrial or statutory policies and procedures) and a copy of any performance reviews conducted by a designated supervisor (who has demonstrable competence in conducting such a review).

No, not 'fecked at all.
I'm not sure, from context, that the above is a major source of the OP's problem. It seems to be what to do with such evidence, eg who to present it to with a view to the 'exclusion' going away and the non-management involveds' heads remaining intact. 'Management' can be awfully good at finding other rules to deal with 'situations' that they find uncomfortable or threatening.
 

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