Thomas A. Crane 2010Supplier Quality 1 Supplier Quality 1. Choose the Right Supplier Audit the Supplier’s Business Verify the Supplier’s Capability 2. Measure Supplier Performance Measure the Supplier’s Quality Performance Measure the Supplier’s Service 3. Develop Supplier Relationship Supplier site visits to communicate concerns Offer suggestions for process capability CTQ control level improvements Encourage development of a continuous improvement program and use of Lean/Six Sigma tools Three aspects of a good Supplier Quality Program

Thomas A. Crane 2010Supplier Quality 2 Supplier Quality 1. Critical Suppliers Critical Suppliers provide parts or materials that are critical to the functionality of your finished product, or are critical to the safety of your employees or the safety of the end user of your product. 2. Major Suppliers 3. Minor Suppliers Not all Suppliers are equal. Some Suppliers are more business critical and require more attention to develop strategic relationships. One way to subdivide Suppliers is to evaluate the parts or materials they provide. Suppliers can be divided into three categories. Major Suppliers provide parts or materials that are important to the efficient production of you product. Parts or materials that have CTQs designated for process control purposes can cause lost productivity, down-time, and higher scrap costs when these parts or materials are out of spec. Minor Suppliers provide parts or materials that do not affect safety, functionality or production of your products. Parts or materials from minor suppliers are normally readily available stock parts or materials, or are available through multiple suppliers.

Thomas A. Crane 2010Supplier Quality 3 Supplier Quality The path to good supplier quality: Critical and Major Suppliers Identify potential suppliers Perform business audit Communicate specifications Sample parts/material approval Pilot run of production quantity Approve supplier Measure Supplier performance Develop Supplier Relationship Minor Suppliers Identify potential suppliers Communicate specifications Sample parts/material approval Run line trial with sample parts/material Approve supplier Measure Supplier performance

Thomas A. Crane 2010Supplier Quality 4 Supplier Quality Identify potential suppliers Choosing potential suppliers is motivated by a myriad of reasons, cost, service, location, leveraging of corporate buys, etc. Regardless of the motivation for adding a new supplier, it is essential to communicate as much as possible during the initial process of requesting quotations. The more information about the parts or material specification, SPC data and certification requirements, expected stocking levels, and packaging and delivery requirements that you can share with the potential supplier the more accurate their quote will be.

Thomas A. Crane 2010Supplier Quality 5 Supplier Quality Perform business audit For critical or major suppliers a business audit should be done before doing business and then on a periodic basis determined by the supplier’s performance. The business audit should include all aspects of the business including: Organization and Management Operational Goals (metric that support the goals) Financial Stability Growth Plan PricingSupplier/Customer Interface (Customer Focus) Management ResponsibilityDocumentation Procedures Change Control Quality PlanningTraceability, Inspection and Testing Process Control and SPCProcess Control Levels (L1, L2, L3 or L4) Metrology Corrective Action and Problem Solving Cost of Quality Technical Capability Handling Storage, Packaging, DeliveryTraining Continuous Process ImprovementMaterials Management Scheduling/Quick ResponseProductivity Facility/Equipment/Layout/CapacityPackaging Equipment and Tooling MaintenanceEquipment/Tooling Design and Qualification Sub-tier Supplier ResponsibilityReliability, Qualification and Audit Testing Employment PracticesEnvironmental and Worker Health & Safety A score card for the audit can be developed to aid in evaluation and development of improvement plans. Each of the categories are scored based on objective evidence shown during the audit. A minimum score can be established to help avoid potentially weak suppliers.

Thomas A. Crane 2010Supplier Quality 6 Supplier Quality Communicate Specifications CTQ Flow-down review and Drawing Updates: The clear communication of specifications and expectations are essential to the success of any supplier quality program. This process begins with your own internal review of CTQ flow-down (see appendix A), drawings, specifications, regulator requirements, and packaging and delivery requirements. These should all be reviewed internally to ensure they clearly convey all the requirements for parts or materials being ordered from the supplier. Review specifications with Supplier: After any updates or modifications have been completed, all the drawings, specifications, regulator requirements, and packaging and delivery requirements should be reviewed, in detail, with the supplier to ensure they are clearly understood. Requirements for SPC data for CTQs and material certifications should be included in the specifications. Review Service Requirements: Service requirements should be included in the specifications in order to make the expectations clear. Expected lead times, stocking levels, any special packaging or shipping requirements, and any lot traceability requirements need to be clearly stated. Verify that the service requirements are understood by the supplier. Review the Supplier Score Card Metrics: Explain the aspects of the Supplier Scorecard Metrics and verify that the supplier understands how their performance will be evaluated (see Measure Supplier Performance section below). Most suppliers will respond to performance metrics if they understand their importance. COMMUNICATE, COMMUNICATE, COMMUNICATE

Thomas A. Crane 2010Supplier Quality 7 Supplier Quality Sample parts/material approval Supplier should supply a minimum of 30 parts with capability data on any CTQs identified or material analysis with a sample of the material analyzed. Supplier should provide Gauge R&R data for measurements systems used to measure the parts or analyze the raw material. If a third party lab is used, then the lab name and address along with the Gauge R&R data from the lab should be provided. Audit the data submitted by measuring the parts or having the material analyzed. This is done to validate the supplier’s capability to measure parts. Perform a line trial with the sample parts or material to verify that they perform properly in your product and that they do not introduce any issues in your production processes. Communicate results to the Supplier. Pilot run of production quantity Order a production quality of parts from the supplier for a pilot run. Supplier should supply capability data for the production run (and/or material certifications) with the parts or material identified with a lot number. Track the use of the parts or material through your production and note any change in production efficiencies, down-time or increases in scrap. Communicate results to the Supplier

Thomas A. Crane 2010Supplier Quality 8 Supplier Quality Approve the Supplier Once the sample parts are approved and pilot run is successful the supplier should be added to the approved supplier list for the parts or material tested and approved All new suppliers should be monitored closely to make sure they can provide quality parts with quality service over an extended period of time. This may require more frequent calculation of their supplier score using the metrics described in the Measure Supplier Performance section below. Measure Supplier performance Measuring the supplier’s performance is a combination of both the quality level of the supplied product as well as the service level provided by the supplier. Quality: Part/Material level PPM Supplier Level PPM Supplier compliance to SPC data or material certification submittal requirements Responsiveness to Corrective Actions Requests and effectiveness to corrective actions taken Service: On-time delivery / Promises kept Order accuracy (item numbers and quantities correct) Compliance to packaging and/or shipping requirements A score card should be generated on a periodic basis and communicated to the suppliers. Corrective actions should be requested if one of the metrics fall below desired level.

Thomas A. Crane 2010Supplier Quality 9 Supplier Quality Develop Supplier Relationship You should develop a strategic relationship with critical suppliers and many of the major suppliers. If possible you should periodically visit the supplier and personally discuss their performance metrics (both good and bad). Encourage suppliers to apply Lean/Six Sigma tools to reduce waste and improve process stability and capability. Help them to understand the power of these tools and how to use them to improve the control levels on CTQs to at least an L2 level (see appendix A for details on control levels). Work with the suppliers to develop continuous improvements projects directed at PPM reduction, improvements to OTD and order accuracy, productivity projects that lead to improved productivity and reduced cost, and project to improve their cost of quality. Projects should be well defined, with stated results that are measurable, and have a well defined timeline and owners identified. Developing a personal relationship with suppliers provides quicker resolution to quality or service issues, as well as improved overall quality and service.

Thomas A. Crane 2010Supplier Quality 10 Supplier Quality - Appendix A CTQ Flowdown Quality Functional Deployment (QFD) Identify customer’s CTQ’s (VOC) Translate customer CTQ’s to product-performance CTQ’s Identify Low level Red X’s that impact Parts/Process CTQs Prioritize the Red X’s Assign current control levels L1, L2, L3, or L4 L1 and L2 control levels are desired for each CTQ CTQ Flow-down -- Identify What to Measure Marketing – Technology – Quality - Manufacturing CTQ flowdown is a form of Quality Functional Deployment (QFD). It is a process for making sure that the Voice of the Customer is reflected in the design and manufacturing of products. CTQ flowdown begins with the voice of the customer and the design process. Understanding the customer needs and expectations along with any regulatory requirements (captured and documented) is the first step. Translating those needs and expectations into product design and easy to understand specifications is the next step. (This is an essential step, both internally for your production and externally for Suppliers) Producing products that meet the design specifications and therefore meet the customer needs and expectations and all regulatory requirements is the final result. A robust Product Design Rationalization process is crucial. Technology design reviews with Quality and Manufacturing are essential for successful CTQ flowdown. CTQ control levels L1 – Mistake Proof (product, part, and/or process designed to ensure the CTQ is met without operator intervention) L2 – Early Warning (SPC is used to monitor part dimensions and/or process parameters to maintain control of CTQ within specification limits. Data can be reviewed for continuous improvement opportunities.) L3 – Operator Dependent (When L1 or L2 control level is too costly or improvement project is a lower priority, then L3 is acceptable if proper safeguards are in place. Clear control plans for process setup and operation, first piece and in-process inspections with data recorded, and frequent quality audits of procedures and records are needed for L3 control level to be effective. L4 – no quality plan (For a true CTQ, this level is never acceptable.)