Eliminating human error

 

No matter how many checks and inspections are put in place, humans are prone to lapses in concentration and making mistakes. With manual systems, a large part of your staffing cost is checking whether colleagues have made mistakes and then putting them right.

Ci-DMS chosen to help deliver productivity and GMP compliance in pharmaceutical manufacturing plants in the USA and Thailand

Catching errors early

When an operator strays from standard operating procedure or makes a mistake in recording, the impact can be minimised if it is identified and rectified right away. However, if an error does go unnoticed the cost implications can be substantial. Even a small mistake can result in an entire batch being rejected, with all the material, production resources and staff time wasted.

The limitations of paper

With paper-based instructions and records, there is no easy way of checking whether operators have started to take shortcuts that expose you to mistakes, nor whether they are completing records diligently, or treating them as a check-box exercise.

With the volume of information and detail in paper batch records, it is very hard for anyone to spot anomalies or variations from standard operating procedure. It is only during the final batch approval process that errors are likely to be picked-up.

Ci-DMS from CI Precision installed at weigh & dispense booths at Eisai

Automating operations and recordkeeping

With an MES system, such as Ci-DMS, the most error-prone manual operations are automated, together with checking and recordkeeping.

The chances of errors are minimised as manual operations are automated and all data entry is validated, whether it is from a barcode, an integrated piece of equipment or the keyboard. If Ci-DMS registers any discrepancies, they are flagged-up immediately and the process halted, preventing the risk of production delay and batch failure.

Supporting checking and supervision

Any MES will keep detailed, accurate batch records; with Ci-DMS this information is presented to auditors and QPs in a form that makes it much easier to review, so they can work quickly while having the greatest chance of spotting any anomalies.

Ci-DMS helps you identify any problematic procedures that need to be redesigned, as well as highlighting any operators who need additional training or intervention.


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