Batch record expertise · Ergonomic batch record
Records that come back for correction, piled-up reviews, finished batches waiting to be released: we simplify your batch records and restructure their review flow, so they are right first time and go through review without waiting.
30 to 60%of unnecessary data removed from batch records
80 to 90%right first time at the end of production, compared with 0 to 10% before
−20 %review time, thanks to fewer correction loops
46 → 34 daysaverage release lead time in one month, thanks to the redesigned review flow
40+sites supported in simplifying their batch recordsAverages observed on our assignments since 2018.
The batch record is a traceability medium, not a control tool.Its review checks the quality of the traceability, not the compliance of production.
Tuesday, 6 pm, the batch is finished. Two weeks later: “a signature is missing on page 12”. The operator is on leave, nobody remembers. What would have taken two minutes on the day takes two weeks, and meanwhile release is on hold.
A simple record isn’t enough if it then waits days in a review queue. We work on both, together or separately.
Less data, a structure that follows the shop floor, errors that jump out: the record is right first time.
Clear review rules, review done on the line and a managed flow: the record goes through review without waiting.
We follow the actual sequence of operations, where they take place and how teams are organised, to remove the back-and-forth in the document that causes omissions.
structureshop-floor reality
Multiple signatures, copied dates, parameters already recorded elsewhere: the C.O.B.R.A. tool analyses each data item with 13 questions to keep only what is useful.
C.O.B.R.A.useful data
11 ergonomic principles create reflexes when filling in and reviewing: omissions jump out and are corrected immediately.
11 ergonomic principlesright first time
When everyone reviews everything, nobody is responsible. We focus each review on real needs and set rules for direct correction, visible in the record.
review rulesdirect correction
On-line review, at the workstation and with a suitable checklist, detects errors while the operator is still there. No record leaves production without being reviewed: final compilation takes 24 hours.
on-line reviewtraceability in-process checks
A short ritual and duration indicators, from end of production to end of quality review, make visible the records that are waiting and quality assurance’s real workload.
throughput timeflow management
Packaging records where the operator was constantly writing, with in-process checks scattered over several pages. A “per shift” structure, copied data removed, times rather than dates.
A sterile filling record in which the operator entered one data item per minute. The C.O.B.R.A. analysis, item by item, with the production teams and QA, objectively determined what had to stay.
Records reviewed at the end of the batch and errors detected days later. Review documents rewritten, direct correction rules, on-line review per shift and flow management, from production to QA audit.
Two tracks in parallel, which you can also run separately: simplifying your records, and restructuring their review flow.
We produce the first ergonomic batch record with your teams. It sets the rules and framework for the whole site: guiding principles, structure, review rules.
Several people are coached in parallel on the following records. Each follows the same steps as we did in phase 1, but they do the work.
For a few weeks or months, your coachees roll out to the rest of the records. Regular check-ins unblock them as soon as they get stuck.
A large volume of records to handle? The Effective Quality Brigade takes on part of the roll-out, using the same method.
with the Effective Quality Brigade
We design the new way of working with you along three lines: review rules, on-line review and flow management.
Updating standards, training on the new way of working, communication, setting up management and change management.
Three months of shop-floor support to secure execution: an intensive first month, then two lighter months.
We help you design a batch release room: a dedicated space where records are reviewed, tracked and unblocked.
batch release roomIt’s a batch record rebuilt to follow shop-floor reality: the actual order of operations, where they take place, how teams are organised. Unnecessary data is removed and the layout makes omissions and errors stand out, so they are corrected immediately.
Above all, data copied several times: multiple signatures, copied dates and times, parameters already present in the raw data. Our C.O.B.R.A. tool (Content Of Batch Record Analysis) analyses each data item with 13 questions to objectively assess its usefulness. Across more than a hundred records analysed, 30 to 55% of the data requested isn’t useful.
Yes. The approach is aligned with regulatory requirements and each removal is justified by a risk analysis. Our clients have in fact had positive feedback in inspections and customer audits, thanks to records that are clearer for operators.
It means reviewing the record during production, at the workstation, with a suitable checklist, rather than at the end. An error found on the line is corrected in two minutes with the operator present; found two weeks later, it takes half a day and blocks release. Review becomes an in-process check of traceability.
It’s the time between the end of production and the end of the quality review. It is what delays batch release. We measure it, manage it with the teams, and restructure the review flow to reduce it.
Not necessarily straight away, but an ergonomic record prepares the ground: the structure is aligned with the real process and the amount of data to integrate goes down, which directly affects the project cost. Ergonomic records are also perfectly suited to the “paper on glass” format.
Tell us about your situation in thirty minutes. We’ll tell you where to start: the record, the flow, or both.