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STANDARDS COMPLIANCE
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LCSIS Supports Quality and Configuration Management Standards - ISO 9000, ISO 10007, EIA/IS-649, MIL-STD-973, CMII
LCSIS - the Life Cycle Support Information System - has been designed to be compliant with a number of commercial, government, and educational standards to ensure that data can be properly entered, maintained, processed, and disposed of in a myriad of environments.
Typical Product Life Cycle - A typical product life cycle will usually consist of 6-8 steps. These steps are usually a progressive buildup to the eventual deployment of your software application. LCSIS uses a 7 step process.
Configuration Management Standards
LCSIS was developed in accordance with the curriculum requirements of the Institute for Configuration Management (ICM), Arizona State University. Specific attention was paid to the details of ICM's CM Software Input and Output Requirements, dated January 13, 1995. This document describes the CM software requirements needed to support a CMII oriented CM process. Physical item hierarchy, physical item-to-document linkage, baseline, and the change process were closely followed.
To ensure that the system could be used in a military environment, both as a production tool and as a management or auditing tool, MIL-STD-973 (Configuration Management) requirements were incorporated. Designers paid particular attention to multiple concurrent baseline management and detailed configuration status accounting.
Particular attention has been paid to the models contained in Electronic Industries Association (EIA) draft Interim Standard EIA/IS-649, Configuration Management, including the Change Management and Configuration Management Sophistication Models. Additional consideration was paid to Typical Status Accounting Information Across the Product Life Cycle.
Because many LCSIS users are engaged in international business, the contents of the International Organization for Standardization's publication ISO 10007, Quality Management - Guidelines for Configuration Management were examined in detail to ensure that LCSIS complies with required international quality standards.
ISO 9000
The ISO certification process begins with a strategic decision to assess the enterprise-wide environment of your company, determine process improvements, and assign the necessary resources to achieve certification and maintain the standard. LCSIS PDM is a proactive step toward ISO 9000 compliance. Specific quality issues addressed by LCSIS features are described in the following paragraphs.
ISO 9000 Requirements Supported by LCSIS Vault Features
In keeping with the management responsibility clause of ISO 9000, LCSIS embeds relevant company policy in change control and workflow features and makes it available throughout the organization by the use of the electronic vault. The LCSIS vaults, workflow task templates, and workflow folders help ensure that your quality systems are complete and documented. The interconnection between vault and baseline structure makes objective standards always available in context.
In the same way, production, installation, inspection and testing procedures are available to product designers. All quality records related to LCSIS processing are retained; additionally, authorized users may attach records documenting quality matters external to LCSIS - from a vendor who does not have LCSIS access, for example - to related LCSIS information.
The company's contract review procedures, embodied in a LCSIS workflow template and documented by associated narratives, are stored in the LCSIS vault. These procedures are available to designated reviewers, including customers who are given LCSIS access.
Checklists and reference documents, such as regulatory requirements, industry standards, and existing engineering notebooks, are attached to product structures under development, through vault entries, in support of ISO 9000 design control goals.
The LCSIS vaults provide rigorous document control. In LCSIS, the term "documents" includes all digital objects - word processing files, scanned image files, CAD drawing files, audio or video files, etc. LCSIS electronic vaults make the current version of documents available by default, although users may elect to view a specific prior version. The reduced floor space required by the electronic vaults makes it practical to maintain copies in disaster storage. Only designated users may update vaulted documents by using the automated LCSIS change control process. Because all users are referencing the same electronic copy of the document, changes are instantly available to all LCSIS users.
Users subject to purchasing clause requirements can enter notes about vendor quality performance, as well as any documentation related to vendor certification and other vendor correspondence, into the electronic vault and attach the vault entry to the appropriate part. In addition, inspection records for purchaser supplied products (customer supplied goods for incorporation into the product) can be entered into the LCSIS electronic vault against the associated item.
Relevant inspection, measuring, and test equipment standards are instantly available from the LCSIS vault, as are handling, storage, packaging, and delivery practices applicable to the product, which are associated with the appropriate baseline(s) when placed in the vault.
All quality records are saved in the LCSIS vault or in electronic folders linked with workflows and automated processes. The electronic format preserves the legibility of the documents (in fact, legibility can often be improved for scanned documents), and provides a systematic method of storing the documents and associating them with the proper quality processes. The electronic format also makes it practical for authorized remote users, particularly customers, to view quality records.
ISO 9000 Requirements Supported by LCSIS Baseline Features
Design control clause elements addressed by LCSIS baselines include attaching checklists and reference documents, such as regulatory requirements, industry standards, and existing engineering notebooks, to product structures under development by completing vault entries. LCSIS also offers comprehensive, automated change control through BOM, as-planned, as-built, and as-modified baselines.
LCSIS baseline and parts features support purchasing clause requirements. LCSIS maintains an approved vendor list against each part in the database. Parts data can be retrieved for specific baseline line items, or through a powerful query against the entire parts database. Inspection records for purchaser supplied products can be entered into the LCSIS electronic vault against the appropriate baseline item.
LCSIS configuration baselines establish clear product identification and traceability for each product, permitting unique, unambiguous marking of components, assemblies, and products. The as-built product serialization tracking feature can also be used for product batch tracking. Product structure and as-built serialization data ensure that the product undergoing inspection and testing is adequately identified. Product baselines also provide data for handling, storage, packaging and delivery functions to identify the product in sufficient detail. Product handling practices applicable to the product are associated with the appropriate baseline(s) and placed in the vault.
Finally, in support of ISO 9000 servicing clause requirements, LCSIS permits authorized users - in the service department, for example - to submit a trouble report to design engineering. Users can monitor the status of submitted reports, and receive a workbasket message regarding the disposition of their trouble report.
ISO 9000 Requirements Supported by LCSIS Change Control Features
To support management responsibility requirements, LCSIS change control features reflect relevant company policy and make policy statements available throughout the organization in the electronic vault. The trouble reporting feature provides feedback on product quality from installation and servicing functions.
LCSIS change control processes and related folders help ensure that the quality system is complete and documented. The task initiation and flow of information controlled by defined processes ensure that the intent of the Quality Manual is realized in practice.
In the same way, design control of BOM, as-planned, as-built, and as-modified baselines is achieved through LCSIS change control features.
Proper document control is assured with LCSIS - only designated users may update vaulted documents using the automated change control process. Because all users are referencing the same electronic copy of the document, changes are instantly available to all LCSIS users.
LCSIS offers an automated formal review and approval process for deviations and waivers to support control of nonconforming products.
ISO 9000 Requirements Supported by LCSIS Workflow Features
Similar to LCSIS change control features, LCSIS workflow features codify relevant company policy and make it available throughout the organization in the electronic vault in support of management responsibility goals. The user/role assignments and tasking in workflow templates clearly define responsibility and authority for quality related matters. For example, a workflow could be scheduled to direct the Quality Manager to perform a periodic review of the quality system.
The LCSIS workflow task templates and workflow folders help ensure that quality systems are complete and documented. The task initiation and flow of information controlled by defined workflow templates ensure that the intent of the Quality Manual is realized in practice. All quality records related to LCSIS processing are retained; additionally, authorized users may attach records documenting quality matters external to LCSIS - from a vendor who does not have LCSIS access, for example - to related LCSIS information.
The company's contract review procedures, embodied in a LCSIS workflow template and documented by associated narratives stored in the LCSIS vault, are available to designated reviewers, including customers given LCSIS access. The LCSIS workflow-guided review ensures consistent contract review processing and records retention.
LCSIS workflow user/role assignments and tasking in workflow templates clearly define responsibility and authority for design and development matters, satisfying numerous design control requirements. For example, a workflow task could direct production to examine drawings attached to the workflow for realistic production tolerances, queue the drawing package to a checker, or initiate a design review by third parties given LCSIS access. Checklists and reference documents, such as regulatory requirements, industry standards, and existing engineering notebooks are attached to these workflow (or to product structures under development, using vault entries). Workflow can also be used to schedule periodic calibration of measurement devices used in product development.
Task folders associated with LCSIS work flows provide users with detailed work instructions - to comply with ISO 9000's process control clause - for the workbasket task. The folders also contain inspection and testing plans. Test results and inspection records can be attached electronically to the workflow folder.
LCSIS workflow templates can be used to schedule designated personnel to perform calibration, inspection, and re-calibration of inspection, measuring, and test equipment. As with all LCSIS workflow activities, users can attach notes, reports, etc. These workflow ensure that only goods that have passed all inspections are released to the customer, in accord with inspection and test status requirements.
To provide control of nonconforming product, LCSIS offers an automated formal review and approval process for deviations and waivers.
Handling, storage, packaging, and delivery workflow can be used to ensure that stored products are inspected for deterioration on a regular basis.
All quality records are saved in the LCSIS vault or in electronic folders linked with workflow and automated processes. These files can be backed up onto CD-ROM, WORM, or other reliable media for long-term, tamper-free storage.
Internal quality audits can be regularly scheduled with workflow templates. Templates designed to route the audit task to management at key steps in the audit process provide high visibility to this important function. Of course, records of the audit remain associated with the audit workflow instance.
To enhance servicing quality, LCSIS permits authorized users - in the service department, for example - to submit a trouble report to design engineering, initiating a workflow process. Users can monitor the status of submitted reports, and receive a workbasket message regarding the disposition of their trouble report.
Summary
LCSIS gives managers the tools they need to replicate and improve existing manufacturing processes. LCSIS, with its comprehensive data control, tracking, and reporting functionality is a cost-effective way to implement quality and configuration management standards compliance in a complex manufacturing environment. LCSIS's object-oriented data vaults and powerful process control capabilities enable you to establish ISO compliant processes, monitor them on a regular basis, and enhance them continuously. |