Are they ready? Production readiness reviews.When placing an order for a substantial quantity of a new product, a company has many concerns. Most are addressed during an initial source selection, when the vendor's basic abilities and product area have been investigated, along with price, delivery history, concurrent engineering approach, and so forth. In addition, there are prototype hardware deliveries that permit your engineers and technicians to verify the robustness of the design, and proper integration with the remainder of the system. Performance also will have been verified at the environmental extremes. However, the prompt-delivery of a few engineering test units does not guarantee that a vendor can consistently provide a product on time and to specifications. In other words, is your vendor ready to turn out the quantities that you need in a timely fashion? The first item of interest is the physical capability to produce; the key word here is quantities. A vendor must have sufficient equipment and space to manufacture, test, pack, and ship the items and sufficient personnel with adequate and timely training to do these tasks. If the vendor does not currently have the resources, there must be a time-phased set of plans (including financing) to show that he will be able to keep pace with the demands of your schedule. These plans may include a new building, space rental, tooling or machinery procurement, upgrading of electrical service, and so forth. Personnel needs may be filled by internal transfers, hiring and training new workers, or subcontracting. If a shortfall is found in either the physical plant or personnel planning, it needs to be remedied immediately. The next item of concern is long-lead parts and materials. Has your vendor performed a production readiness review (PRR) on his vendors? The vendor's purchasing department must know the latest lead-times. You do not want to be the victim of a schedule slippage because your vendor cannot get timely delivery of the items needed to manufacture your product. In the same arena is the possibility of obsolescence. Are all the components projected to be available (at the same or decreasing cost) through the life of the program, including the items that may be needed for repairs long after the last unit has been shipped? Scarce or discontinued items can wreak havoc with a schedule. A retest with a modified design early in the production cycle is a small price to pay for the assurance that your vendor's manufacturing system will not have delivery problems later. The availability of production tooling and test equipment must also be assured. Usually, the prototype units are manufactured by engineers and technicians using whatever tools and equipment are available. However, your vendor's production engineering staff has to think in a larger sense and procure equipment oriented towards volume production. After the production tooling and test gear have been identified, questions must be asked about when it will arrive and how soon it (and the operators) will be qualified. On your end, your final design review should have checked on the availability of engineering drawings and found them complete. Your next question should be how well they are translated into work instructions to be used by assembly and test personnel, and when the work instructions will be implemented. If the work instructions are not yet finished, make sure that this will not affect early deliveries negatively. You should also confirm that your vendor can adequately validate work instructions with a well-documented and proven procedure. The skills necessary for the various tasks should not be beyond the skill levels of the available personnel. Now that the more mundane preliminaries have been addressed, issues currently in the forefront of manufacturing systems interest may be examined. Be aware, however, that shortcomings in any of the areas mentioned above can cause serious programmatic problems, as can deficiencies in a modern manufacturing system. The first of the "hot-button" areas to examine is selection of key product characteristics. Does the vendor's assessment of what is key agree with yours? If not, now is the time to resolve the discrepancies. The vendor's key product characteristics need to be those that you are using for interface and integration. They will have the most impact on the final system if not controlled adequately. How the vendor is controlling the selected key product characteristics must also be examined. If they are properly tied to key manufacturing processes controlled by means of SPC or automated machinery, then there should be few problems with the end products. The key manufacturing processes should be identified logically. (Both Boeing's D-1-9000 and the automotive industry's QS-9000 provide good methodology for doing this.) Appropriate controls can then be established to assure that they are maintained within acceptable limits. Next, validate the process capability of the key manufacturing characteristics. Whether to use a process capability index (Cpk) goal of = [is greater than] 1.33 (true 4-sigma capability), a goal of Cpk = [is greater than] 1.5 (Motorola's "6-sigma" capability), or some other minimum Cpk goal must be negotiated between you and your vendor. The differences in projected maximum defect rate (63ppm vs. 3.4ppm) will not make as much of a difference in the real world as the systematic effort used by a company to attain or exceed its chosen goal. The vendor's validation plan is even more important than the selection of a key process Cpk goal. When is the validation of key process capability, using production equipment and personnel, to take place? What is the mitigation plan to assure delivery of acceptable product before validation is complete and/or if the process proves to be incapable? It is prudent to assess independently the risk of the vendor not achieving a key process capability goal and to formulate contingency plans to improve his process if there is a shortfall. Finally, reassess the vendor's overall product assurance system. Even if a survey was conducted as part of the initial source selection process, it is beneficial to re-examine the vendor's QA proactivity, certified vendor system, flow-down of key characteristic requirements to its subcontractors, general use of meaningful SPC, and effectiveness of its closed-loop corrective action system. A good start is an assurance system compliant with ISO-9000, QS-9000, or some other industry standard, but compliance with just one of these standards is not sufficient to guarantee manufacturing system readiness for timely delivery. A robust, affordable design produced by a concurrently involved manufacturing group is only the first step towards rate production. Your company needs to be assured of on-time delivery of good product as well. Make sure that all your key vendors are as ready to produce as you are so that neither a high-tech "hot button" nor a low-tech sleeper spoils your production schedule. Edmund S. Fine is a senior engineer specializing in manufacturing and product assurance. He is currently employed by the Advanced Systems Group of Sverdrup Corp. in Huntsville, Alabama, as a consultant to the U.S. Army. |
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