QA and only QA, or Jack of all Duties? Crossing Departmental Boundaries

normzone said:

Well, there's all these nails, and to top management I look like a hammer.

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Your Management Team should look at Section 5: LEADERSHIP

I believe that they don't quite understand what that means.

I describe as feeling like the nerds doing everyone else's homework. For example, they want to change a process and its documentation. They show you what they want changed and have tons of information and ideas until you say-"fantastic, I can give you a CI number" and suddenly it's just something they thought you would want to change, and they don't have time to do all of that.

Hanna B said:

I describe as feeling like the nerds doing everyone else's homework. For example, they want to change a process and its documentation. They show you what they want changed and have tons of information and ideas until you say-"fantastic, I can give you a CI number" and suddenly it's just something they thought you would want to change, and they don't have time to do all of that.

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If you think of such a situation like a problem solver instead of an issuer of numbers for (and filing clerk of) change documents, you would see this as an opportunity to educate staff and streamline the organization by pointing out the value added and, ultimately, time saved when the folks who will implement the changes are directly involved in transferring all that "information" into the changes and evaluating the efficacy and value of the changes in real time.

Well, THAT was an interesting trip down memory lane - I had to have one of those flashback scenarios (cue special effects from your generation's video) to remember what triggered this post. I'm thankfully with a different employer since then.

Same challenges, better paycheck and work (mostly) from home - closest I'll ever get to retirement. The biggest challenge is that there's only forty hours in a day.

Wes Bucey said:

If you think of such a situation like a problem solver instead of an issuer of numbers for (and filing clerk of) change documents, you would see this as an opportunity to educate staff and streamline the organization by pointing out the value added and, ultimately, time saved when the folks who will implement the changes are directly involved in transferring all that "information" into the changes and evaluating the efficacy and value of the changes in real time.

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Could you please advise on the practical steps to transform this into a QA initiative where QA plays a problem-solving role?
We've been following these steps, but as Hanna mentioned earlier, it often seems to result in delays.

1. We regularly send reminders to process owners to review SOPs and relevant quality documents annually or whenever there are changes in systems or processes. Typically, QA becomes aware of these changes through informal communication or official announcements.

2. However, we often end up having to ask the process owners for details about the changes and also end up amending the SOPs ourselves. This leads to lengthy discussions, back-and-forth exchanges, and sometimes it takes over a year to update the quality documents, which is not owned by QA.

Thought of issuing NC to these process owners for failing to update the SOPs, despite reminders and offers to discuss, but that doesn't seem to be an effective solution. People tend to react negatively to NCs for such matters.

How can we implement a positive reinforcement approach to encourage process owners to willingly update all quality documents?
I'm no longer in the QA role but anticipate taking it on again in the future as the business requires. I expect to face the same challenges again.

Your instructor's perspective on focusing strictly on QA/QC to avoid dilution of your primary Quality responsibilities is a common and valid viewpoint in the field of Quality Assurance (QA). It's essential to maintain a clear delineation of roles and responsibilities to ensure that each team or department can focus on their core functions and expertise.

Murni Ahmad said:

Could you please advise on the practical steps to transform this into a QA initiative where QA plays a problem-solving role?
We've been following these steps, but as Hanna mentioned earlier, it often seems to result in delays.

1. We regularly send reminders to process owners to review SOPs and relevant quality documents annually or whenever there are changes in systems or processes. Typically, QA becomes aware of these changes through informal communication or official announcements.

2. However, we often end up having to ask the process owners for details about the changes and also end up amending the SOPs ourselves. This leads to lengthy discussions, back-and-forth exchanges, and sometimes it takes over a year to update the quality documents, which is not owned by QA.

Thought of issuing NC to these process owners for failing to update the SOPs, despite reminders and offers to discuss, but that doesn't seem to be an effective solution. People tend to react negatively to NCs for such matters.

How can we implement a positive reinforcement approach to encourage process owners to willingly update all quality documents?
I'm no longer in the QA role but anticipate taking it on again in the future as the business requires. I expect to face the same challenges again.

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I sense
[old guy speak for "common knowledge among experienced hands for DON'T ASSUME PROCESS HOLDERS HAVE KNOWLEDGE HOW TO SYSTEMATICALLY REVIEW PROCESSES AND EVALUATE CHANGES"]
the root cause of the apparent disconnect is that communication is NOT a two-way process. Typically, "reminders" from Quality are just "noise" to the targets of the reminder because those targets see themselves as the only ones doing real work.

Ultimately, it's a culture problem which must be recognized before it can be remedied to benefit the organization. Often, the issue stems from the top down.
REMEMBER: "Tails don't wag dogs!"

Wes Bucey said:

I sense
[old guy speak for "common knowledge among experienced hands for DON'T ASSUME PROCESS HOLDERS HAVE KNOWLEDGE HOW TO SYSTEMATICALLY REVIEW PROCESSES AND EVALUATE CHANGES"]
the root cause of the apparent disconnect is that communication is NOT a two-way process. Typically, "reminders" from Quality are just "noise" to the targets of the reminder because those targets see themselves as the only ones doing real work.

Ultimately, it's a culture problem which must be recognized before it can be remedied to benefit the organization. Often, the issue stems from the top down.
REMEMBER: "Tails don't wag dogs!"

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I think this more accurately speaks to my frustration. I've done everything I can to facilitate communication and get people to value ownership, as have previous women in my position. Unfortunately, this habit is deeply engrained. When doing this year's audit, I went back to the very first one from 18 years ago and the trend is clear. Fortunately, upper management has made some significant changes this year to position people to better involve those on the supply and sales side in following the processes they helped create according to the DCNs reviewed along with past audits. I'm less the filing clerk type and more the person who spent the 10 previous years trying to get 3–5-year-olds to do things they didn't want to do either so Quality Assurance is a pretty good fit in that regard.

Interesting that six years later, it seems nothing has changed. I too face a constant ask of piling more hats on top of my head. Yes, we are a small startup so that's to be expected, however some of the asks don't make a lot of sense. While I'm all for making myself valuable to the company and at the same time expanding my knowledge and experience (this has happened tremendously here and I'm really happy about it), I do also encounter those instances where something is presented to me as a task I'll do "just this once" because of whatever circumstance but you KNOW if you do it once, it's likely just going to become yours for...ever? This situation and the hats that really don't fit are the ones I try to dodge. Sometimes successfully, mostly not.

@normzone , does the fact that you are at a different company now hint at how this whole situation worked out for you? Did you regret crossing that boundry?

FRA 2 FDA said:

Interesting that six years later, it seems nothing has changed. I too face a constant ask of piling more hats on top of my head. Yes, we are a small startup so that's to be expected, however some of the asks don't make a lot of sense. While I'm all for making myself valuable to the company and at the same time expanding my knowledge and experience (this has happened tremendously here and I'm really happy about it), I do also encounter those instances where something is presented to me as a task I'll do "just this once" because of whatever circumstance but you KNOW if you do it once, it's likely just going to become yours for...ever? This situation and the hats that really don't fit are the ones I try to dodge. Sometimes successfully, mostly not.

@normzone , does the fact that you are at a different company now hint at how this whole situation worked out for you? Did you regret crossing that boundry?

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The boundary crossing was not an influence - while I was not enthused about it, I found effective/efficient methods to deal with being pushed across the boundary. My previous employer grew weary of my insistence that we meet customer requirements and they "decided to go a different direction". Just as well, all things considered.