Show TOC

 Sample Management (QM-IM-SM)

Purpose

The Quality Management (QM) application component includes comprehensive functions for processing and managing physical samples during goods receipt and in production . The Sample Management component supplements the existing QM functions for processing samples by allowing you to:

  • Flexibly plan the drawing of physical samples

  • Identify physical samples on the basis of unique, client-specific keys

  • Record inspection results for physical samples

  • Manage the physical-sample data in the system

Sample Management supports many of the requirements in the process industry for documenting and tracking the physical samples drawn in quality inspections. It provides the QM component with many of the functions that are typically found in Laboratory Information Management Systems (LIMS).

Implementation Considerations

Sample management capabilities are particularly important in the food, chemical, and pharmaceutical industries, where products are often subjected to complex chemical, organic, and physical quality inspections. You should consider implementing Sample Management if your company needs to:

  • Process different types of physical samples (for example, goods receipt samples, production samples, competitor samples)

  • Draw different categories of physical samples (for example, primary samples, pooled samples, and reserve samples)

  • Define procedures for drawing physical samples based on different inspection processing procedures

  • Plan sufficient quantities of physical samples for multiple inspections

  • Store and track physical samples for a specified period of time

Integration

The functions of the Sample Management component (QM-IM-SM) are integrated with the QM functions for planning inspections, processing inspection lots, and recording inspection results.If you want to process and manage physical samples using the Sample Management component, you must also implement the following components:

  • Quality Planning (QM-PT)

  • Quality Inspection (QM-IM)

Features

Sample Management gives you increased flexibility and control in the following areas:

Inspection planning
  • You can create sample-drawing procedures to define your strategy for creating and drawing physical samples. For example, you can specify:

    • Which categories of physical samples should be drawn (for example, primary samples, pooled samples, and reserve samples)

    • How many physical samples must be drawn

  • If your materials are delivered in different types of containers, you can define different procedures for drawing physical samples from different container types.

  • To activate the functions for sample management, you must assign a sample-drawing procedure to a task list. As a result, the information in the sample-drawing procedure applies to all materials that are inspected with the task list.

Inspection processing
  • The system automatically creates physical-sample records for all planned physical samples when it creates an inspection lot A unique physical-sample number identifies each physical sample.

  • The system assigns all physical samples that were created automatically for an inspection lot to a physical-sample drawing . Using this number, you can determine how many physical samples were drawn from an inspection lot and how many pooled and reserve samples were created.

  • In addition to the planned, automatically generated physical samples, you can create physical samples manually.

  • You can record inspection results for all automatically and manually created physical samples.

  • When you make the usage decision for an inspection lot, you can display an overview of all processed physical samples with their respective statuses.

  • You can track the physical samples after the inspection by recording the physical sample location data in the physical-sample records.