The documentary record is important, particularly for products manufacturers, but care must be taken that policies are in place and pitfalls are avoided
IT IS vitally important to the proper development of a product to encourage an open exchange of ideas, to make certain that the product is developed within proper protocols and then to document these facts and the reasons design decisions were made. Communication in the design, testing and production process is paramount and it is for this purpose that manufacturers keep records.
The primary purpose of a documents management program lies in the management, retention and destruction of electronic and hard documents in the course of the day-to-day operations of a business. It assists the manufacturer to build a better and safer mousetrap by creating a library for new product design and performance, to comply with certification and reporting requirements, and to respond to calls for information--sometimes many years after the individuals involved have departed.
However, in an age when product liability litigation in the American market is a given, and where it is growing elsewhere, manufacturers must assume that their records will be discovered and, if at all possible, used against them. How those records are created and maintained will be crucial when the company finds itself on the witness stand.
Creation of a comprehensive documents management or retention policy as early as possible is an important component of presenting a "product story" in litigation of almost every type. Credible engineers involved in the design of the product become even more credible when their testimony is supported by documents. Documents are useful to establish that manufacturers have explored problems and have done what was appropriate to close any open issue. Documents also can be helpful in impeaching the testimony of turncoat employees. For all these reasons, it is critical that manufacturers tightly control the creation and retention of their documents.
A carefully developed documents management program is crucial to the successful operation and development of any business, not merely a products manufacturer, and many general issues in developing and maintaining such a program apply across the board. The selected topics in this article focus on products liability issues as examples, but other businesses also are all too often engaged in litigation, or are required to file or maintain documents for a myriad of governmental regulations, or are targets of governmental action. Whether prosecuting a plaintiff's business tort or commercial claim, complying with European Community environmental directives, or seeking credits under sentencing guide lines, the company must have the documents to support its claim or show its compliance with applicable laws.
DOCUMENT MANAGEMENT FOR PRODUCT MANUFACTURERS
A. Government and Industrial Standards
A proper documents management and retention program begins with the creation of a system and library that includes these standards on a current basis and alerting designers to changes. Compliance with governmental and industry standards is a minimum requirement in product development and in the defense of a product.(1) Whatever type of documents management policy is adopted, it is essential that the policy comply with applicable governmental regulations. For example, the Office of the Federal Register publishes the Guide to Record Retention Requirements, which digests provisions of U.S. federal laws and regulations relating to record-keeping requirements. The guide describes (1) what records must be kept, (2) who must keep them and (3) how long they must be kept.
B. Design Review System and History of Design
Manufacturers should establish clear and coherent product history records stating the reasons why they chose certain design alternatives or followed certain procedures. …