Improvement Plan for existing QUALITY TEAM

v9991

Trusted Information Resource
Any plan would have to suit the specific requirements&scenario...
However, the broad approach(template) would be more or less same...

what are your comments on below template/section to recommend the improvement plan/outlines !!! (btw, this is an plan for an already existing&functioning team scenario)
So, improvement is envisioned in following four broad areas...
1) Quality objectives ( effectiveness :- impact on product, customer, outcomes )...basically compliance to current status.
2) Quality improvements (impact on status-quo ) ... basically improvement of processes.
3) Team Management ( efficiencies :- organization of team, its tactics, knowledge sharing )... efficiency etc.,
4) team member (competency building)
 
Last edited:

v9991

Trusted Information Resource
I would like to hear from you all experts out there and probably get inspired.

how do you plan for monitoring/improve (effectiveness and efficiencies) your quality team and impact-created by your quality team.

i understand that each specific scenario&time requires different approaches/solutions, but like to hear from experts about what worked and what didn't.

And also recommendations/thoughts about same are very much welcome.
 

Pancho

wikineer
Super Moderator
I would like to hear from you all experts out there and probably get inspired.

how do you plan for monitoring/improve (effectiveness and efficiencies) your quality team and impact-created by your quality team.

i understand that each specific scenario&time requires different approaches/solutions, but like to hear from experts about what worked and what didn't.

And also recommendations/thoughts about same are very much welcome.


I'm not sure I know what you mean by "quality team". Is it the inspectors and other QA personnel? Or the iso 9000 def for "audit team"? Or a small group in the organization that is in charge of the QMS? Or process owners? Or "top management"? Or the whole company?

If the last, then in answer to your question, ISO 9001 is how we do it.
 

v9991

Trusted Information Resource
I'm not sure I know what you mean by "quality team". Is it the inspectors and other QA personnel? Or the iso 9000 def for "audit team"? Or a small group in the organization that is in charge of the QMS? Or process owners? Or "top management"? Or the whole company?

If the last, then in answer to your question, ISO 9001 is how we do it.

I think I understand ISO 9001 part of it.... which mandates some objectives - monitoring - reviews etc., ( :tg: most of times, its something external/mandated/imposed/obligation etc., ;) )

here I am referring to a small group in the organization that is in charge of QMS. ( and this is typically in the development R&D environment)
 

Pancho

wikineer
Super Moderator
We have a "quality committee", but truth be told, it doesn't do much anymore. Maybe it just obsoleted itself. And that's a good thing.

The committee's original main activities were documenting and maintaining the QMS. These activities were taken over by everyone in the company shortly after we adopted a wiki as our platform for the QMS and empowered everyone to edit system documents. Now the committee's main activity is to sit with external auditors at the beginning and end of such audits.

The wiki's collaborative environment allows everyone in the company to improve processes and documentation. People new to wikis worry that their use will lead to chaos and poor documents, but the surprising fact is that wiki content improves rapidly instead. Everyone wants to be at their best when their work is on display companywide, and small improvements accumulate. Seeing this is fun and fosters teamwork, breaking both silos and glass ceilings.

So, maybe we should disband our quality committee, or better yet, enlarge it to name everyone a member. But then our auditor will probably be even less inclined to pickup the after-audit-dinner bill.

Here's another take on wiki use for managing quality.
 

Chennaiite

Never-say-die
Trusted Information Resource
I think the approach shouldn't be any different from proving impact of any other team, for that matter. And why should it be.

What Responsibilities QMS team holds in your Organization. How is it linked to your R&D objectives and in turn to your Organization's overall Vision/Mission, etc. Who are your Internal/External Customers and what are their needs. What are the Variation observed in the Process handled by the team and What are the Variations in the Process outputs. Understanding Variations does help in identifying meaningful Performance Indicators for the team. Unless otherwise these are clearly established, its quite difficult to prove your positive impact on measurable terms. Of course, we may claim walking NC-free out of External audit, lot of improvements in the process, etc, but ultimately the data has to speak on our behalf.
 

v9991

Trusted Information Resource
Of course, we may claim walking NC-free out of External audit, lot of improvements in the process, etc, but ultimately the data has to speak on our behalf.
thats exactly where the " - - - " is...
being an R&D environment, we do not have any external audit...
any product launch/tech-transfer is the core function of R&D...not us/QA
any improvement system specific or product specific does go through a technical review committee....hence its scrutinised-subjective (priorities & discretion!!!)
... so on and so forth...

i was just wondering why does QMS rely so much heavy on generic CAPA process.
its quite not often atleast in pharma to see it integrate with some specific methadologies and tools for problem solving or improvements... viz., QMS (i agree these tools also come with they own set of process steps but still i believe there is tremendous value in adopting&integrating them into QMS)

the point is it will help bring objectivity to the whole process. (atleast in the areas of problem solving and improvements!!! )
 
Top Bottom