FR

Case study · Batch records

From 0 to 90% of batch records right first time, with 65% less data

On this site, which produces commercial and development batches, no record left production without correction. After coaching on about ten records, the site’s teams took over on nearly 280 records.

CDMO · solid dosage forms · 600-person siteRoll-out in progress

The results

0 → 90 %of records right first time at the 1st review
100 %right first time at QA review
−65 %of data to be entered in the records
1 min → 2 min 30between two data entries by the operator

Results measured on the batch records actually finalised.

The starting point

  • A commercial solid dosage production site, which also produces development batches.
  • No record right first time at the first review, at the end of production.
  • One data entry every minute on average: a constant burden for operators.

What we did together

  1. Analyse the recordEach data item screened with our C.O.B.R.A. tool (13 questions), and the structure compared with the actual sequence on the shop floor.
  2. We do it for youA first prototype built with the team, following our 11 ergonomic principles, then tested in production.
  3. You do it, we coachThe site’s teams design the following records, with our support at each step.
  4. Define who reviews whatTargeted review rules and direct corrections, to avoid back-and-forth.
  5. You roll it outThe site extends the approach to its other records, with regular support sessions.

More reliable, and much lighter

Right first time at the first review, and volume of data to enter (base 100 before the project).

BeforeAfter
Packaging

4 records coached, then 78 records rolled out by the site.

Manufacturing

4 records coached, then 94 records being rolled out by the site.

Development

2 records coached, then 105 records being rolled out.

An autonomous site

the method has been handed over: the teams simplify their records on their own.

Our takeaways

The coaching covers only about ten records: it’s the handover of the method that then lets the site simplify hundreds of records by itself.

The approaches used

Our advice if you’re getting started

  • Start with a few well-chosen records: they serve as models for all the others.
  • Train internal writers: they are the ones who will carry out the roll-out.

Do your batch records always come back with corrections?

Let’s talk about your records: together we’ll analyse a typical record and what it costs you in review.