Multiple Specifications
Definition
Different inspection specifications for an inspection characteristic in the quality management area. These different specifications may include customer requirements, requirements specified by pharmacopoeia or authorities, country-specific legal requirements, or internal company requirements. Such specifications, for example, may consist of different tolerances or characteristic attributes.
Use
You should use multiple specifications if your materials or batches must conform to different specifications because they are used for different purposes. When you define different specifications for a material, the system will check these specifications when inspection results for the material are valuated. You can valuate a batch on the basis of multiple specifications and determine the "suitability" of the material, which can subsequently be taken into account when dispatching the material. This suitability can help you determine whether or not the batch can be delivered to a specific customer or area.
Structure
The multiple specifications for an inspection characteristic always reference the material and another object such as a customer, country, or pharmacopoeia.
A multiple specification may consist of a release specification and a shelf-life specification: the release specification is checked by the system when the multiple specifications are valuated, while the shelf-life specification serves as information only (for example, in a quality certificate).
Release specification (internal specification)
The release specification (or internal specification) specifies the release requirements. The release requirements are the tolerances against which a material is inspected and the tolerances that must be fulfilled when a batch is released. These specifications must be fulfilled in order to be able to sell or use the batch (these specifications are checked when the multiple specifications are valuated). A release specification, as it applies to multiple specifications, can be object related. Release requirements can therefore exist for both the standard specifications as well as for other object-related multiple specifications.
Shelf-life specification (external specification)
A batch can only be stored for a limited amount of time (shelf life). During this time, the shelf life requirements must be fulfilled. These specifications are broader than the release specifications, for example, because the potency of active ingredients may decline over time. These are the specifications with which the customer is normally familiar. They are recorded in the shelf life or external specification and certified on a quality certificate. If shelf-life requirements are not explicitly specified, then the release requirements also apply for the shelf life.
You do not inspect against the shelf-life specification; this data is provided for informational purposes only, for example, for the printing of the quality certificate.
With multiple specifications, only one release specification and one shelf-life specification can exist for an inspection characteristic and an object (two different specifications for a single set of multiple specifications). You can also just work with release specifications.