A Performance Management Tool

Mismatches of production capacity between manufacturing levels will give rise to multiple lots at a lower level being accumulated into a single lot or order at a higher level or to a single lower-level lot being issued to multiple higher-level lots or orders. Mis­matches of production capacity within a manufacturing level will cause sub-lots to be created, which may be evident from the pattern of material issues or of product receipts.

The lot traceability system will reveal all instances of multiple lot issues or receipts and of significant processing time variations between successive lots of the same material or between related materials at different levels. These may be reported automatically as exceptions. Excessive or repeated multiple lot occurrences will

demonstrate capacity mismatches and the consequent need to replan or replace equipment or to redesign processes.

Many materials and most finished products have specified expiry dates, after which they should not be shipped or used or both. Others require to be re-validated periodically to confirm potency, concentration, etc. The lot traceability system will report lots reaching or exceeding their expiry or retest dates, and may transfer these delinquent lots automatically into another reserved or non-issuable status.

The lot traceability system in this instance not only helps to control lot dating but also reports on delinquency. Management will wish to ensure that the number of such delinquent lots is kept to a minimum to reduce material and overhead costs. Naturally the consequences of a lot passing its expiry date are more serious than those of passing a retest date. Expiry and retest date information is always available lot by lot and can be separately analysed if required to supplement the standard information.

Pharmaceutical companies are no more immune from the batching syndrome and end-of-week syndrome, where recording of mate­rial movements is delayed for subjective reasons, than any other type of company. As elsewhere, these delays can have serious effects on data integrity with receipts being recorded before issues, produced lots being used elsewhere before recording is complete for the originating order, events being recorded sepa­rately and differently from materials, etc.

The lot traceability system will reveal, because of the detailed time-stamped operator-linked transaction data stored by it, the true nature of such recording delays and discrepancies. Many of them may further be highlighted by lot traceability system excep­tion reporting. Not only is the need for good data integrity even stronger in pharmaceutical manufacturing operations than else­where, management has a better chance of identifying and cor­recting the problem thanks to the additional level of detailed recording dictated by and made possible through the lot traceabil­ity system.

The preceding section has shown how a number of important manufacturing performance indicators can be generated via a lot traceability system. The data maintained by such a system is an important resource, but is too often neglected.

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