Synopsis of Activity
When specifying what is to be purchased, many companies and government agencies use detailed drawing packages to define the end product by component. This method facilitates outsourcing, interchangeability, and commonality of goods received by different manufacturers. This, however, requires the purchaser to maintain internal R&D, drafting, and engineering resources, or to use outside resources, for these activities. Recently, many end users have reorganized their procurement processes to push the product development costs back to the manufacturers. This method uses performance criteria to establish desired outcomes rather than component drawings which define the product. For example, rather than designing a specific size cup, made out of a certain material, in a specific shape; the performance criteria, like temperature ratings and volume, and any other limiting factors, would be requested. This allows manufacturers to use COTS (commercial off the shelf ) products or to incorporate experiences gained through past programs to develop creative solutions. Both processes have their limitations, and both require specialized support that can be provided by BEC Corporation. This document deals with the latter procurement process and attempts to offer a brief explanation of the activities performed when evaluating a manufacturer's ability to conform to the need of the client.
Most, if not all, quality programs require an approved vendor list from which items can be ordered. This list contains the names of those vendors who have been audited to verify that their internal processes conform to some quality standard. However, products are sometimes required that have never been previously manufactured by an "approved" company. This "approval" process is where BEC Corporation is recognized as an industry leader. For several years now, we have performed supplier qualification programs for multi-million dollar projects and the process we have created has proven to be successful. This process is composed of three (3) sections: Pre-qualification, Design Review, and Manufacturing. All of the sections are not required for all contracts. What steps are necessary depends on the cost and critical nature of the item being purchased. The following paragraphs describe the activities performed during each of these sections:
The pre-qualification process consists of a preliminary design review, a quality systems review, and a general assessment of the manufacturing capabilities; and is the only step performed on all perspective manufacturers. The intent of this process is to determine whether the manufacturer is capable of meeting the requirements of the contract and to recommend any additional amendments to protect the interest of the end user. It eliminates the manufacturers who do not have the capacity, the experience, or the necessary controls to ensure conformance to specifications.
The preliminary design review looks at the viability of the proposed item(s) to be manufactured. The type of information reviewed depends on where the company is in the design process. The information supplied is compared to the customer's requirements and a determination is made as to whether or not the design can, or will, meet the requirements. The general dimensions are reviewed for form, fit, and function. Test reports are compared to performance requirements. And, if required, testing is witnessed or participated in. If necessary, the materials are evaluated by a metallurgist or polymer specialist for applicability to pertinent conditions. Any concerns are identified and the projected impacts on the program are stated.
The quality systems review is an audit of the company's infrastructure in accordance to the relevant quality documents (i.e., GMP, ISO, API, etc...). Major and minor observations are reported to the client and a recommendation as to the impact on the prospective project is rendered. If critical components are outsourced, it is recommended that the quality systems audit be performed on those sub-contractors as well.
The general assessment looks at headcount, equipment utilization, shrink rates, and other parameters and evaluates the manufacturer's ability to achieve schedule. The results of the preliminary design review and the quality systems review are compiled with the general assessment of the manufacturer's capabilities and a summary report comparing each perspective manufacturer is submitted.
Formal Design Review
Once the contract has been awarded, the manufacturer is contacted to schedule a formal design review. This review focuses on the engineering drawings and supporting calculations. A tolerance stackup is performed on the critical components, and calculations for major load bearing components are reviewed. Material specifications are compared to any approved material lists and, if available, Finite Element data is evaluated. A summary report is created listing all findings and submitted to the client.
Prior to manufacturing the first article, a review of the manufacturing process is performed. This review looks at the machine/tool qualification, maintenance records, inspection procedures, outside vendor processes, and process routers. Third party hold points, witness points, and special inspection/process identifiers are verified on the routers. Once the manufacturing process is approved, the first article is run. Final assembly is witnessed, and any functional or product testing of the first article is performed. If no further involvement is required after the first article, a summary report of the first article run is compiled and submitted to the client. If further activities are required, manufacturing monitoring continues until production is completed. Activity reports are submitted either weekly or monthly, and a final report is generated upon program completion.