A Performance Management Tool

This vital data has been somewhat neglected in pharmaceutical environments. Yet, incorporating various time elements such as clean-down, equipment reconfiguration, make-ready and valida­tion, it provides one of the keys to reducing campaign sizes, increasing flexibility and responsiveness, and reducing cost [4, 6]. The systematic recording and analysis of changeover time is beyond the capabilities of either a conventional lot traceability system or a conventional material control system, except by a deductive process comparing one order with its successor.

A material control and lot traceability system that can record by-products, however, can be used successfully for changeover recording if the critical equipment is designated appropriately in the system, e.g. as a tool (a special type of recursive by-product), and given a lot identity.

This time is the actual time taken to process (manufacture or pack) a single unit of the material being produced or a complete manufacturing order or perhaps a single lot if one order represents multiple lots. The time extends from the start of the first manu­facturing operation (or from the last material issue necessary before manufacturing can start) to the recording of the first completed unit or transportable quantity such as a pallet load or the last such completed unit or transportable quantity.

The lot traceability system contains details of every issue and receipt transaction. Apart from the date and time of the start of the first manufacturing operation, which a lot traceability system will not normally retain, all other data required to construct a full lead time picture is resident in the lot traceability system, whether manufacturing orders result in one lot or in multiple lots.

These time elements together represent the time required for manufactured or purchased material to pass from a received but uninspected status to full approval or possibly rejection or refer­ral.

It would be possible for a lot traceability system to record sampling and analysis operations as equivalent to manufacturing orders but this is unusual. More common is for a Laboratory Information Management System (LIMS) to be linked to the lot traceability system so that approvals or other status changes can be transmitted automatically from the LIMS to the lot traceability system. Alternatively, status changes may be recorded directly in the lot traceability system or material control system. Addition­ally, if the sample quantities are significant they should be recorded as material movements, with accompanying time-stamp data.

In any case, the lot traceability system contains as a minimum full data on time, date and operator identity of every status change transaction. A longer-term picture of actual analysis lead times can therefore be built up material by material, and can be used to confirm and update the planning records for anticipated lead times, and to serve as a focus for necessary management action.

To be Continued

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