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| Introduction
The ANSI/UL 1998 standard is focused toward 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, ANSI/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. A 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. The process of defining what is necessary for compliance with a software engineering process standard such as “ANSI/UL 1998 Standard for Software in Programmable Components” is often confusing and laborious because the directions contained in the standards are unclear or ambiguous. To aid in determining what is actually “required” by the document in the way of physical evidence of compliance, the experts at SEPT have produced this checklist. This checklist is constructed around a classification scheme of physical evidence comprised of policies, procedures, plans, records, documents, audits, and reviews. There must be an accompanying record of some type when an audit or review has been accomplished. This record would define the findings of the review or audit and any corrective action to be taken. For the sake of brevity this checklist does not call out a separate record for each review or audit. All procedures should be reviewed but the checklist does not call out a review for each procedure, unless the standard calls out the procedure review. In this checklist “manuals, reports, scripts and specifications” are included in the document category. When the subject standard references another standard for physical evidence, the checklist does not call out the requirements of the referenced standard. The Author has carefully reviewed the document “ANSI/UL 1998 Standard for Software in Programmable Components” and defined the physical evidence required based upon this classification scheme. SEPT has conducted a second review of the complete list to ensure that the documents’ producers did not leave out a physical piece of evidence that a “reasonable person” would expect to find. It could certainly be argued that if the document did not call it out then it is not required; however if the standard was used by an organization to improve its process, then it would make sense to recognize missing documents. Therefore, there are documents specified in this checklist that are implied by the standard, though not specifically called out in the document, and they are designated by an asterisk (*) throughout this checklist. If a document 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 “Verification Plan" could be a part of the "Design and Development Plan". 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 the organizational requirements do not call for this physical evidence for a particular project, this should also be denoted with a statement reflecting that this 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 these documents could vary from paragraphs to volumes depending upon the size and complexity of the project or business requirements. General Principles of the “ANSI/UL 1998 Standard for Software in
Programmable Components” Checklist
Using the Checklist
Detail Steps
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| 1. The title of the documented evidence specified by the checklist (document, plan, etc) agrees with the title of the evidence being planned by the organization. | Record in checklist that the organization is compliant. |
| 2. The title of the documented evidence specified by the checklist (document, etc) disagrees with the title of the evidence planned by the organization but the content is the same. | Record in the checklist the evidence title the organization uses and record that the organization is compliant, and the evidence is the same although the title is different. |
| 3. The title of the documented evidence specified by the checklist (document, etc) is combined with another piece of evidence. | Record in the checklist the title of the evidence (document, etc) in which this information is contained. |
| 4. The title of the documented evidence specified by the checklist (document, etc) is not planned by the organization because it is not required. | Record in the checklist that the evidence is not required and the rationale for this decision. |
| 5. The title of the documented evidence called out by the checklist (document, etc) is not planned by the organization and should be planned by it. | Record in the checklist when this evidence will be planned and reference a plan for accomplishing the task. |
| Components of the Checklist
This checklist is composed of 9 sections:
All reasonable questions concerning this checklist or its use will be addressed free of charge for 60 days from time of purchase, up to a maximum of 4 hours consultation time. Warranties and Liability
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| ANSI/UL 1998 CLAUSE NUMBER and NAME | POLICIES and PROCEDURES | PLANS | RECORDS | DOCUMENTS | AUDITS AND REVIEWS | |
| 3 | Risk Analysis | . | . | . | . | . |
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3.1
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3.2
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3.3
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3.4
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| 4 | Process Definition | . | . | . | . | . |
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4.1
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4.2
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4.3
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4.4
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4.5
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4.6
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4.7
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Traceability Matrix Report Records |
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4.8
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5
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Qualification of Design,
Implementation and Verification Tools |
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5.1
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Qualification Records |
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5.2
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Records |
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Software Design | . | . | . | . | . |
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6.1
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6.2
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