How to be more efficient in Medical Device QA and save money?

S

SteveK

#1
We had our annual Management Review meeting recently as required by ISO 13485/9001. The MD raised a requirement for efficiency targets i.e. in all departments including Quality. Now we are a small medical device company (less than 30 people on site) and I guess our quality systems are pretty much ‘mature’ (according to our auditors anyway!). I am the only Quality Assurance person (Manager) and apart from giving myself a good stern talking to, I am a little lost in how to set meaningful targets or measuring my efficiency (or otherwise). Apparently the efficiencies should lead to cost savings i.e. the main driver for this exercise – so I suppose I could sack myself (main QA cost being my salary, plus using stationary and purchasing the odd Standard from time to time)!

Obviously I try to have preventative (and corrective) actions in place to stop any costs relating to potential quality issues – such as reducing defects, complaints, returns etc. However, these are often outside my direct control e.g. the customer orders the wrong item (Sales Department), they have tampered with a device (Customer), our courier decides to have a head on crash thus causing some transit damage (Production/Dispatch), item costs too much (Purchasing Department), customer does not like the colour of the device (Design Department) or they were overcharged (Accounts).

Using less paper and printer ink might save a few bob in my case– any other money saving ideas through efficiencies for a Medical Device QA Department (Manager)?

Steve
 
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yodon

Staff member
Super Moderator
#2
Hmm... Clearly your first failure was not being inefficient earlier. :)

So where do you spend most of your time? Do you have to do much firefighting or is it all just routine stuff?

Maybe you can push the angle that your efficiencies are realized throughout the organization. Ooh... maybe take a cue from the 'green' initiatives and have efficiency credits (kind of like the carbon credits). Sorry, getting a little crazy (I'll blame the Texas heat). Maybe you can glean some ideas from here, though.
 

harry

Super Moderator
#3
................. However, these are often outside my direct control e.g. the customer orders the wrong item (Sales Department), they have tampered with a device (Customer), our courier decides to have a head on crash thus causing some transit damage (Production/Dispatch), item costs too much (Purchasing Department), customer does not like the colour of the device (Design Department) or they were overcharged (Accounts). ..................
Elevate yourself to the position of a 'coach' and these are the areas where a lot can be gained from coaching and influencing.
 

sagai

Quite Involved in Discussions
#4
Hi Steve!

I would suggest some ...
- trends of non conformities over external/internal audits , having less and less due to result of the continuous improvement of the QMS of your company, lack of CAPA means savings in spending time and money on their elimination,
- I would a bit spend on the opportunities may hidden in complaint management, as a potential next area for improvement,
- the continuous improvement also means that you do not bind your company into stupid unnecessary non productive work related rules by the QMS because of expertise on regulatory real needs and as such, you also save on that way money for the company.
- driving the company on improvement via continuous persuasion of the management (e.t.c.: MRs)

Regards
Sz.
 
S

SteveK

#5
Thanks for trying guys!

In last external audit – no NCs. Last internal audit a few weeks ago led to a couple of minor CAPAs – in fact we seldom have many overall issues of NCs and that includes suppliers and our production operations (very occasionally there is the odd cock-up though). I keep a PDCA log of our ‘continuous improvement’ activities - these have recently included some colour differentiation of one of our product lines, improving servicing labelling to avoid customer confusion, extra labelling to stop customers loosing small items in packaging etc. In reality we do not get too many customer complaints – fairly recently invested in some new packaging equipment to avoid the worst effects of the head on collisions I indicated (alright - rough handling!). Things really are mainly routine (as raised by Yodon – and I have looked into low carbon footprint type stuff and I wish we had some ‘Texas Heat’ – swap you for some North of England rain!) and there is not really any slack (I also make sure we are not tied down by any silly rules etc and I am quite good on the management persuasion/coaching side of things).

Steve
 
R

rgmain

#6
In some form or another (Written or Verbal) there must be business stratigy mapping which peaks at the quality objectives, there is where you will find cost savings. Think business management system not quality management system.
 

Attachments

S

Sybarite

#7
One potential target for cost savings or increased efficiency is looking at turn-around-times for business processes that touch QA. For example, if manufacturing DHR's must be reviewed by you or your team before a batch can be released, then begin measuring how long it takes and identify ways to speed it up.

I would suggest doing some "voice of the customer" work, treating internal functions such as operations as your customer. You may discover some pinch-points that you can address and increase efficiency, or at least customer satisfaction.
 

DannyK

Trusted Information Resource
#8
Suggest to map your processes and set goals or targets for the outputs. You can then measure of the effectiveness of the processes.
You can also look at cross training. If you or another key person was not at work, who would do what. One of the objectives or targets could be related to having a flexible work force so that you or other key employees can take a vacation once in a while.
 

sagai

Quite Involved in Discussions
#9
Hi Steve!
who does the internal audit in your company in order to preserve "auditor do not audit its own work" concept?
Thanx, Regards
Sz.
 
S

SteveK

#10
Hi Steve!
who does the internal audit in your company in order to preserve "auditor do not audit its own work" concept?
Thanx, Regards
Sz.
A member of production (trained up by me) conducted the internal company audit - however I (as QM) did the audit of his (production) area. The last external auditor was OK with this to preserve "not auditing own work".

Steve
 
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