Overview

If a company produces products that have software in a programmable component that possibly could cause bodily harm, they need to adhere to safety standard UL 1998. This SEPT checklist is designed to ensure that the required artifacts (procedures, plans, records, documents and reviews) have been produced to meet the requirements of UL 1998. While helping you meet the UL standard, it will also save you time and money while doing so.

The UL 1998 Standard

The UL 1998 standard is focused on application-specific, non-networked software in a programmable component that is embedded in a product for which a failure may result in injury to persons.  In addition, UL 1998 is a reference software standard intended to be used in conjunction with any product specific safety standards that address safety requirements for the identified programmable component and the product hardware.

The software configuration of a microprocessor based programmable component typically includes the operating system or executive software, communication software, micro-controller, input/output hardware, and any generic software libraries, database management or user interface software.

Background of SEPT Checklists

For 25 + years Software Engineering Process Technology (SEPT) has produced checklists for international and national process standards. They have been produced for Medical Devices, Quality, Security, and Software processes.

Organizations buy and use these checklists to perform a gap analysis between what a particular standard requires and what their organization does. This

1. Ensures that all the artifacts cited in the standard are addressed,
2. Provides traceability between artifacts in the standard and the organization's process step that produces the artifact,
3. Demonstrates that the organization has followed “best practices” in case of litigation,
4. Reduces cost by procuring an “Off the Shelf” checklist rather than developing one internally,
5. Ensures use of a checklist compiled by a company experienced in deciphering standards and verified by domain experts.

How the UL 1998 SEPT Checklist was Constructed

The first step in construction of the checklist was to determine all of the artifacts (procedures, plans, records, documents, or reviews) that the standard requires. Sometimes what constitutes required physical evidence (artifacts) to meet the UL1998 standard is difficult to identify. To bridge this gap the author and SEPT experts have identified items of physical evidence called out in the standard based on their knowledge of the document and their experience in the standards field. Each item of physical evidence that was identified by these experts is listed in the checklist as an artifact - a procedure, a plan, a record, a document, or a review.

Sometimes we call out an artifact that is not expressly required by the standard. In such cases, we flag that artifact with an asterisk (*) to indicate we suggest that it be produced even though it is not specifically called out by the standard. If an artifact is specifically called out by UL1998, it appears in the checklist without an appended symbol.

Whenever a review takes place, there must be an accompanying record of some type indicating that the review has been performed. This record would define the findings of the review and any corrective action to be taken. For the sake of brevity this checklist does not call out a separate record for each review. All procedures should be reviewed but the checklist does not call out a review for each procedure unless the standard calls out that the procedure be reviewed. Where records are cited as artifacts, reviews of the records are not included, but we would expect a review to be held.

The author has carefully reviewed the UL1998 Standard and defined the physical evidence required based upon the classification scheme of procedures, plans, records, documents, and reviews. SEPT’s engineering department has conducted a second review of the complete list and baseline standard to ensure that the documents’ producers did not leave out a physical piece of evidence that a “reasonable person” would expect to find. If an artifact is called out more than one time, only the first reference is stipulated.

There are occasional situations in which a procedure or document is not necessarily separate and could be contained within another document. For example, the “Software Design Operation and Safety Features Document” could be a part of the “Software Design Document”. The author has called out these individual items separately to ensure that the organization does not overlook any facet of physical evidence. If the organization does not require a separate document, and an item can be a subset of another document or record, then this fact should be denoted in the detail section of the checklist for that item. This should be done in the form of a statement reflecting that the information for this document may be found in section XX of Document XYZ.

If organizational requirements do not call for a physical evidence for a project, this should also be denoted with a statement reflecting that the physical evidence is not required and why. The reasons for the evidence not being required should be clearly presented in this statement. Further details on this step are provided in the Detail Steps section of the introduction. The size of documents called out in the checklist and the standard itself can vary from paragraphs to volumes depending upon the size and complexity of a project or business requirement.

Required artifacts gleaned from the UL1998 standard have been transferred into checklist tables, based on the type of artifact and the standard section in which they occur. In total, there are 208 artifacts identified by SEPT in the checklist, of which 69 are required and 139 suggested.

This is a checklist to help you meet FDA requirements for electronic records and signatures. The checklist uses a classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. Identifying over 50 pieces of physical evidence, this checklist clarifies what is required for compliance to this standard by providing an easy-to-use product evidence list.

A quality product at a reasonable price, this checklist will save you time and money, and aid you in meeting certain governmental requirements.

New! Interested in an unlimited 5-year corporate license for this product? Contact Stan Magee at stanmagee@smartwire.net.

Now! The experts at SEPT have produced a checklist for this major software engineering standard: "General Principles of Software Validation - Final Guidance for Industry and FDA staff. The Checklist uses a classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. The Checklist clarifies what is required for compliance by providing an easy-to-use product evidence list that will assist any software organization in meeting the requirements of this guide. A quality product at a reasonable price; this checklist will save you time and money, in meeting governmental requirements.

The experts at SEPT have have created a checklist to help ensure that the you have complied with the requirements specifed in the FDA document, "Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, as amended in 2005 by FDA's guidance on compliance for cybersecurity.
The Checklist provides an easy-to-use classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. The Checklist clarifies what is required for compliance through a product evidence list that will assist any software organization in meeting the requirements of these FDA guideline.
Use of our checklist will save you time and money, and may aid in meeting governmental requirements.

SEPT has produced a checklist for the FDA Document, "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices." This is a "must have" for all quality managers and engineers involved in this FDA document. The Checklist uses a classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. This standard calls out or suggests over 120+ items of physical evidence. The Checklist clarifies what is required for compliance by providing an easy-to-use product evidence list that will assist any organization to meet the requirements of this important standard.

New! Interested in an unlimited 5-year corporate license for this product? Contact Software Engineering Process Technology (SEPT) for more information!