Three Ways our Batch Records set us up for Failure (and how to address them!)

One of the ways we can improve Batch Record Right First Time (RFT), and hence throughput time, is by improving the Batch Record design.  By reengineering the document we can reduce the opportunities to make errors.  Batch Record (BR) redesign is an important part of a Lean QA (Lean in Quality Assurance) project, because it not only addresses RFT and throughput time, but it also leads to a reduced review effort (and hence workload) for manufacturing and QA reviewers.

1. Redundant entries

Over time, BRs become large, unwieldy documents, due to successive changes and additions, usually as a result of investigations or deviations.  The record content and sequence often deviates from the current manufacturing process.  While the process may have been improved/changed, the BR has stayed the same, so there can be several entries which are “N/A”, or do not impact the quality of the batch.  Other common examples are multiple “sign/date” entries for concurrent steps, which are always performed by one person at one time, and therefore could be consolidated as a single “sign/date”.  All such redundant entries offer opportunity for error!  So, given that the number one error usually found in batch records is “missing entry”, the removal of unnecessary entries is a great way to improve RFT.

2. Excessive Transcription

The second most common error found in batch records is usually “transcription error”: either transcription of values from (validated) process equipment, or transcription of data from one page of the record to another.  Making use of validated systems and attaching print-outs or reports instead of re-writing them further reduces the need for operator entries.  Remember:

The more entries that exist within a record the more opportunities for errors!

Tackling transcription and redundancy can lead to a big decrease in the number of entries.  In previously completed projects we have found a 20-50+% decrease in entries.  (The range usually depends on how long the BR/product has been in production.)

3. Poor Document Design & Sequencing

Now that we are left with the entries which are critical to quality, we should lay them out in a logical manner.  It is common to find that operators have to flip backwards and forwards in BRs to fill in required entries, thus increasing the likelihood of entries being missed.  Even within single pages entries can be disorganized.

Clear, visual document design makes it very obvious when an entry is missing or wrong, and can be considered to have three cornerstones.  First, address BR sequence by designing the BR to follow the process as closely as is practical.  Second, all entries should be on one side of the page where possible, and their location highlighted by using shading/colors/visual indicators.  Third, make the review of the document easier by highlighting (again, using shading/colors/visual indicators) who is responsible for reviewing what on each page, and also what their review should be determining.

By critically examining the batch records and redesigning them in a logical, well-laid-out way we can reduce errors, reduce the need for corrections loops and thus shorten the time needed to complete and review a Batch Record.  The reduced effort required by both operators and reviewers results in improved quality, and also improved productivity!