How Traceability Turns Quality Assurance Into Quality Insurance

April 2016

A good quality management software application can do a great job of calculating statistical data, managing control limits, documenting test results, and managing test plans. But quality management and compliance with regulatory requirements—as well as the policy imperatives of companies and their customers—requires bullet-proof documentation and traceability that involves the entire technology infrastructure represented by your ERP system.

Quality management and process control are assumed. The resulting data is no-doubt stored in the systems and available for analysis and reporting. To complete the picture, though, it is necessary to trace components, ingredients and products from the source, through manufacturing and storage, and out through the distribution chain to the ultimate customer. That traceability, if done right, need not be a burden to operational personnel nor a complication that impacts process efficiency.

The key is in capturing data at the source, at the time of the activity, using automation and auto-ID technology. The detailed data is stored in a comprehensive database with appropriate tools for retrieval and analysis.

In some industries, full traceability is required. In others, it’s just good practice. In the event of a quality problem or product failure, full traceability can isolate the affected products and greatly limit the extent of any recall or corrective action. In less dire circumstances, traceability can be an aid to product performance analysis, improvement initiatives, material and supplier evaluation, and service planning, to name a few.

Traceability means full identification of each component, batch or lot number (if appropriate), source, any documentation associated with the receipt, and other information. As those components and materials are used, the date/time, batch, and product information is attached to the transaction record. Through the production process, it is also sometimes useful to capture equipment and operator details, environmental conditions and measurements, or test results. Finished goods tracking, to the same level of detail, provides a record of product movement, environmental conditions (if appropriate), and chain-of-custody through the supply chain.

All connected in a comprehensive database, end-to-end traceability allows full documentation to be available to support the above-mentioned objectives:

  • Compliance
  • Quality assurance
  • Minimizing risk
  • Product improvement

Not all of this detail is necessary in every situation, but having full traceability is a kind of insurance. It may never be needed, but if you ever do need it, you, your customers, stockholders, and regulators will be very glad you have it.

What objectives does traceability help you achieve in your business