ISO Certificate Tracking
Michael’s team of buyers maintains the most current copy of each supplier’s ISO certificate on file, but their method of tracking it is unique. On each purchase requisition, the buyer is required to look up the expiration date of the certificate and write this date on the requisition. Therefore, if a certificate is nearing its expiration date, the buyer will request an updated certificate along with the next purchase order. If the supplier fails to provide an updated certificate, the incoming inspection team could place the next shipment on hold until the updated certificate is received. This mechanism ensures 100% compliance.
Use of Quality Manuals
The team requests quality manuals from suppliers, but the manuals are used by the supplier auditing team to plan audits. The manuals list all the relevant supplier procedures, and there is a process interaction diagram that the audit program manager uses to plan the audit agenda.
The team has done an exceptional job of working with other departments in the company to develop a detailed supplier questionnaire that is specific to the needs of orthopaedic contract manufacturing. The questionnaire covers aspects such as raw material traceability and incoming inspection methods—critical for preventing use of metals that might be out-of-specification. The questionnaire also includes questions about inspection equipment that the supplier has available to perform final inspection and to generate statistical process control (SPC) charts.
Reduced Sampling Justification
The company uses the last piece of information in the supplier questionnaires, supplier SPC capabilities, as a strategic competitive advantage. Most suppliers are forced to absorb the cost of performing 100% incoming inspection of all dimensions for purchased components from second tier suppliers. This company uses SPC data to categorize supplier tiers. If a supplier provides SPC data as part of the documentation for each lot of components shipped, then incoming inspectors review SPC data to verify that the process parameters match validation run data. If data analysis indicates that process parameters resulted in an abnormal data distribution for any dimension, incoming inspectors perform inspection of that dimension(s) using a tightened sampling plan. All other dimensions are sampled on a normal or reduced sampling plan—based upon the process capability for each dimension.
“Dock to Stock”
The team also requests that SPC data is emailed in advance of parts. This gives the inspectors more time to review documentation and helps the company adjust their schedule to compensate for possible component supply shortages. SPC reports are requested in a standardized format with color coding of the process capability for each dimension. Any suppliers that use this format, and consistently demonstrate that their processes are at least 99.9% capable of meeting customer specifications, are eligible for the “Dock to Stock” program. “Dock to Stock” parts receive a special acceptance sticker, and parts are moved to inventory without incoming inspection. Not all customers allow this, and therefore this option is tracked at the individual component level and documented in the company’s MRP system.