Real Time Review™ of Batch Records can be quite a departure from the current review process in most Life Science companies. It will typically mean migrating from the commonly found process in which you find multiple stages and levels of review, by several Manufacturing and QA personnel, to a quicker, more efficient review process.
The standard processes have evolved in an attempt to “make doubly (or trebly) sure” that errors are detected. However, they are characterized by review queues/backlogs at every stage of the work stream, with punitive correction/rework loops associated with each one. This “queued” process is also exacerbated by inadequate definition or clarity around what must be reviewed at each stage, usually leading to several non-value-added reviews of the same thing.
Even after going through multiple levels of review there is still a poor Right First Time (RFT). This leads to very long lead times for documentation review, resulting in a lot of running around and ‘pulling’ from QA to get batches dispositioned when they are required. It also becomes common-place to process/package at risk and ship under quarantine.
Implementing Real Time Review™ in manufacturing means that the major parts of both production and QA reviews are performed on the floor during the manufacturing/packaging process. There are a number of benefits of moving review closer to the time of entry, including improved RFT, shortened correction loops and decreased review cycle times.
To deal with poor batch record RFT in many sites there are semi-regular documentation training sessions, usually precipitated by an increase in the number of errors in batch records. There is often limited success with these training sessions, where people are assembled in a room and made to sit through a PowerPoint presentation containing many abstract errors.
A more useful form of training is the continuous training opportunity provided by Real Time Review™. In this scenario the close link between the error being made and the presence of an expert who can explain, in person, how to correctly rectify the error is a much more meaningful training process. This is also useful in areas where there are a number of contractors working or where there is a high turnover of employees. It also provides a direct link to QA where operators can give feedback and ideas on ways to improve the batch record.
This physical interaction between the reviewer and operator also removes the opportunity for confusion which often occurs when the communication is happening through Post-its®. It’s not uncommon to have batch records cycle through a corrections loop more than once due to a misunderstood Post-it® comment.
Direct interaction between the reviewer and operator can greatly reduce the time taken for documents in the corrections loop and reduces movement of batch records, meaning there is less need for the chasing and finding of records, which can come to represent a significant portion of a QA reviewer’s day.
Also, in situations where corrections are made closer to when the entry was added, the operator is more likely to remember what the entry should have been, making the correction more straightforward. Early review also has the opportunity for catching mistakes which would lead to starting investigations earlier in the process, or preventing the continued processing/packaging of a product which is not saleable.
There are a number of entries which can be reviewed in real time and others which can only be reviewed after the Batch Record is 100% completed (such as LIMS references, final review of alarms etc.) Part of the preparation for Real Time Review involves identifying these different types of entries, along with clearly defining the prescribed review process (i.e. which entries are being reviewed at each level of review) and designing ways in which the responsibility is assigned.
Overall, once these types of entry are distinguished, we end up with a much shortened ‘final’ review by production and QA, which reduces the effort and cycle time for lot disposition.
Having implemented Real Time Review™ in manufacturing settings, as one part of an overall Lean QA project in many sites, BSM has experience in managing this mindset change, resulting in greater project success and sustainability. Coupling Real Time Review™ with other elements of a Lean QA project, including leveling, standard work and visual management, results in reduced time from manufacture to release, increased RFT and increased productivity.
Check out my other blog on Three Ways our Batch Records set us up for Failure (and how to address them!)
This blog was written by Adrian Fegan, Principal Consultant at BSM-USA. If you would like further information on Real Time Batch Record Review or any other aspect of Real Lean, send an email to Adrian Fegan.