Change Management for Recipes 

Use

Depending on the branch of industry and product, manufacturers in process industries must comply with different legal requirements as regards the planning, documentation, and release of recipes. For this reason, recipe management offers different editing methods allowing different levels of freedom during recipe editing and guaranteeing change documentation of a varying extent. Depending on the recipe type, the editing method can either be freely chosen or is firmly defined.

This section provides an overview of the editing methods available in recipe management and the functions that you can use to evaluate the editing steps performed.

Integration

Recipe editing is not only regulated by the editing method but by status management as well. You use the recipe status, for example, to release recipes and protect them against improper changes.

Depending on the recipe type, status management can be active or inactive, it can take dependencies between change states into account, and you can enhance it using your own status profile. In this way, your process will become more or less strictly regulated depending on how you decide to combine editing methods and status management.

See also: Status Management and Scope of Application

Prerequisites

The required combination of editing method and status management has been activated for your recipe types (see Customizing for Recipes, IMG activity Recipe Settings). If you have to comply with the requirements of Good Manufacturing Practices (GMP) for the pharmaceutical industry or a similar standard, we strongly recommend:

●     Activating status management for your recipe types

●     Specifying that change master records be used

Features

Recipe Editing

Function	Description
Recipe Editing Without Change Master Records	This function enables you to freely create and change recipes on a key date. Changes you make are logged in change documents. However, you do not get a change history in the form of different change states.
Recipe Editing With Change Master Records	This function enables specially authorized users to plan, create, and document change states in a detailed manner. Changes you make are logged in change documents as well. In addition, you obtain a change history in the form of defined change statuses.

Recipe management only supports change master records with date validity but not with parameter effectivity.

Evaluating Changes

Function / Procedure	Description
Evaluating the Use of Change Master Records	You evaluate which change master records are used in recipes and formulas as well as their scopes of application. You receive an overview of the change states and scopes of application created using a particular change master record.
Evaluating Change Documents	You evaluate the change documents created for a recipe or change state. You receive information about the values that were changed, the person who changed them, and the date when they were changed.