Document control of spreadsheets

[RR1]

I currently use various excel spreadsheets in workbook formats: examples are

QI workbook contains:

1. QI logs/ status for current year and previous year
   
2. Audit template of scheduled and ad-hoc audits/ planning for next year
   
3. spreadsheet of SABRE/ SHOT reports cross- ref to the QI numbers
   
4. Quality metrics
   

Equipment workbook contains:

1. Equipment log
   
2. Temperature mapping schedule
   
3. Calibration schedule
   
4. PPM schedule
   
5. Cleaning schedule template
   

I also have excel workbooks for training, management stuff, specific quality stuff. I am sure many of you also use spreadsheets- but how do you manage these with your senior team? How many people do you allow access to modify if these are on a shared drive?

Thanks.

[bmsjbatt]

Hi Rashmi,

For both of these areas (BTW our equipment stuff is mostly done on Q-Pulse), the only people with access are ; myself as QM, the BBM, SPOT and Senior in BB. but it is only accessed in a heirarchical manner, that is, the SPOT is responsible for anything ward based, the BBM for all lab based unless he is unavailable then the Senior acts as deputy with SPOT support, I just act as general dogsbody to monitor and tidy up occasionally.

[RR1]

Hi Jo, how do you document control these spreadsheets/ workbooks?

As this was one given as a non-conf. at inspection, I have since then added a spreadsheet reference, and version number to control the actual template for each worksheet. These details are then held (in another spreadsheet!!!), and will have a formal review date.However, as these are still developing they will most likely be reviewed much more often.

My staff are concerned with being able to trace back the previous versions of the spreadsheet, so how do you hold these? How relevant is it to hold the previous formatted template anyway?

Thanks

[bmsjbatt]

Hi Rashmi,

What reference did they give to accompany the Non conf?? If they didn't give a reference I would argue the non conf. or ask them to reference the regulation they are using to support the N/C.

I would agree that the Format of the worksheet can be document controlled and be part of your usual document review cycle and link it's review to that of the SOP that it is mentioned in, but the worksheet itself cannot be controlled as it is a working document, provided that each action / entry can have an appropriate date and signature attached to it (could always use the track changes function in excel?)

For our QI worksheet I have shamelessly stolen and modified your spreadsheet and it was accepted as a suitable worksheet by our MHRA inspector when we sent it to him to close a post inspection N/C of us not having an overall monitoring tool.

Hope this clears things up a bit:)

[RR1]

Hi Jo, the following was cited:

Documentation was inadequate in that:

Equipment calibration and servicing spreadsheets were not appropriately controlled

(Ref: SI 2005/50 9(1)a,b,c,d,e EUGMP 1.2 (iii);vi;2.9;4.2;4.3;5.21;5.23;annex 15#22;#43).

But thinking about this further- I do print the equipment spreadsheets off and attach on our lab wall for staff, so the citation is correct, these should have all had a reference /cross- ref'd to an sop.

Have you managed to adapt the QI worksheet into an Access database? That's my next step- as I gather Access is far more flexible.

thanks for your help.