OMNIPLESS MINIMUM REQUIREMENTS FOR MANUFACTURERS

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1 PURPOSE: The purpose of this document is to describe the minimum level of requirements that Omnipless expects from manufacturers of Omnipless designed components. Table of Contents 1 Scope Means of understanding Approved suppliers and Sub-Contractors Material Identification Traceability Storage Lean Manufacturing Skills, Facilities and Equipment Skills Equipment and Facilities Process Capability Process Control Definitions Techniques Yield Analysis Run Charts Analysis Planning and Scheduling Routing Work Instructions Jigs and Fixtures Inspection Equipment Calibration Reports Inspection Levels Maintenance of Records Finished Goods Storage Packaging Reports Marking Returned and Non-Conforming Goods Rework and Repair Corrective Actions Revision Control ESD Requirements Risk FMEA Form #: 875-A0051 Issue 2.0 PAGE 1 OF 11

2 1 Scope The suppliers described in this document are those suppliers that are classified as manufacturers, i.e. they manufacture components that are under Omnipless design control. The term Manufacturer also applies to Printed Circuit Board Assemblers. 2 Means of understanding In this document, the use of words shall, should, must, will, may shall observe the following rules: The word shall in the text denotes a mandatory requirement. Departure from such a requirement is not permissible without formal agreement. The word should in the text denotes a recommendation or advice on implementing such a requirement of the document. Such recommendations or advice is expected to be followed unless good reasons are stated for not doing so. The word must in the text is used for legislative or regulatory requirements (e.g. Health and Safety) and shall be complied with. The word will in the text denotes a provision or service or an intention in connection with a requirement of this document. The word may in the text denotes a permissible practice or action. It does not express a requirement of this document. The requirements of this document shall be mandatory for S-Category Suppliers. The words shall, must and will applies, thus for S-Category Suppliers replace should with shall in paragraphs 3 onwards. 3 Approved suppliers and Sub-Contractors The supplier should have a supplier selection process that is used to maintain a list of approved suppliers, from which all materials are sourced. The supplier should keep records of the performance of these suppliers, in terms of quality and delivery schedule. These records should be used for reviewing the approved supplier list. These records should also be provided back to the suppliers, in order to encourage continuous improvement of the supply chain. As the purpose of approving suppliers is to establish a confidence in the quality and delivery schedule of manufactured product, Omnipless wishes to avoid approved suppliers sub-contracting work to unapproved second tier suppliers. Sub-contractors used by suppliers shall be approved by Omnipless. Where Omnipless specifies the manufacturer of a specific item or service, then this manufacturer shall not be changed without prior agreement, in writing. Where authority is granted by Omnipless, the flow down requirements and key characteristics, to sub-tier suppliers will be clearly noted in the purchasing documentation. Form #: 875-A0051 Issue 2.0 PAGE 2 OF 11

3 4 Material 4.1 Identification The supplier shall ensure that all raw materials are sufficiently identified so as to avoid the incorrect use of materials during manufacturing. 4.2 Traceability The supplier shall ensure that a system of traceability exits on all materials used in the manufacture of a product. According to the level of traceability required, by contract, regulatory, or as defined in the manufacturing documentation, the suppliers system shall provide for: o Where acceptance authority media are used (e.g. stamps, electronic signatures, passwords) the supplier shall establish and document controls for the media. o o o Identification to be maintained throughout the product life. All the products manufactured from the same batch of raw materials or from the same manufacturing batch to be traced, as well as the destination(delivery, scrap) of all products of the same batch. For an assembly, the identity of its components and those of the next higher assembly to be traced. For given product, a sequential record of its production (manufacture, assembly and inspection) to be retrieved. 4.3 Storage All Omnipless supplied materials shall be securely stored by the supplier in satisfactory conditions such that those materials are not degraded or misplaced. 5 Lean Manufacturing The supplier should adopt the principles of lean manufacturing placing emphasis in the following areas: o Resolving problems at source and applying the right first time approach to improve quality and productivity. o Reducing waste and inventory by removing non value added activities. o Implement a Continuous Improvement Plan to reduce costs and cycle times. o Developing long term relationships with its suppliers and customers through information and risk sharing. Form #: 875-A0051 Issue 2.0 PAGE 3 OF 11

4 6 Skills, Facilities and Equipment The supplier shall have the skills, facilities and equipment capable of providing a service, as offered to Omnipless, to industry leading standards. 6.1 Skills The supplier shall be able to understand and control their process capabilities, and be able to share this information with Omnipless as part of concurrent engineering development of new items for manufacture. 6.2 Equipment and Facilities The supplier shall have equipment and facilities capable of delivering the offered service to Omnipless. Equipment shall be repaired, maintained and calibrated to ensure a continued and reliable service to Omnipless. Repair and maintenance procedures should be documented. 6.3 Process Capability Definitions: Process Capability: A statistical measure of the inherent process variability for a given characteristic. The most widely accepted formula for process capability is six sigma. Process Capability Index: The value of the tolerance specified for the characteristic divided by the process capability. The several types of process capability indexes include the widely used C pk and C p The supplier shall be able to understand and control the Process Capability of their manufacturing processes, and shall be able to advise Omnipless on possible tolerances and results that can be reliably achieved. The supplier should be able to demonstrate the Process Capability of the various manufacturing processes using statistical analysis techniques on actual measured values. The supplier should have an understanding of the process variables that contribute to the variances of the production processes. Form #: 875-A0051 Issue 2.0 PAGE 4 OF 11

5 7 Process Control 7.1 Definitions Process Control: The methodology for keeping a process within boundaries; minimizing the variation of a process. Statistical Process Control (SPC): The application of statistical techniques to control a process. The term "statistical quality control" is often used interchangeably with "statistical process control." 7.2 Techniques The supplier should use Process Control techniques to optimise the manufacturing process to reduce the overall costs Yield Analysis The supplier should keep records of the yield of each manufactured item: o Yield at incoming inspection o Yield at each process point o Yield at outgoing inspection o % of goods returned by the customer. This yield information should be analysed and corrections implemented such that the quality of the product, and the overall cost, is continuously improved Run Charts Run charts are recommended to control processes directly at the processing stage, such that manufacturing of batches can be controlled rather than checked after processing. The generation of these run charts shall be real-time, in order for the chart to be effective. 7.3 Analysis Captured data shall be analysed and used to improve the process. o Analysis should be within a reasonable period of time to ensure that process corrections can be done prior to the manufacture of excessive scrap. o Failures should be analysed and communicated to ensure that concerned individuals understand the acceptance criteria. o Visual management techniques should be used to communicate the data to concerned individuals. o Metrics should have trigger points. When the results fall below these trigger points, corrective actions should always be actioned. o Concerned individuals should be made aware of the failures that result from their processes. Form #: 875-A0051 Issue 2.0 PAGE 5 OF 11

6 8 Planning and Scheduling The supplier shall demonstrate that it has considered all of the Supply Chain principles and have systems to manage the: o The ordering of raw materials and their inbound logistics. o Production Planning the system is sufficient to ensure that Omnipless will receive the manufactured items by the due date specified on the purchase order. o Warehousing and Distribution logistics. 9 Routing Each manufactured item (or batch of items) shall be accompanied through the manufacturing process by a job card. This card should identify the build status of the item, and be structured so as to describe the manufacturing flow, and also to provide a reference to the progress of the items through manufacturing. 10 Work Instructions The supplier shall maintain sufficient work instructions to ensure that the complete production flow for the component can be completed without input from any specific individual. This documentation shall also be sufficient to ensure consistent and similar processing of different batches of components. 11 Jigs and Fixtures Jigs and fixtures used by the supplier should be documented such that these can be replaced in the event of loss or damage. The jigs and fixtures should also be identified to ensure that the correct jigs are used as per the manufacturing instructions. Procedures shall cover the calibration and maintenance of jigs and fixtures. Form #: 875-A0051 Issue 2.0 PAGE 6 OF 11

7 12 Inspection The supplier is responsible for all inspecting and testing of components supplied to Omnipless, to verify that the components comply with the specified requirements Equipment The supplier shall have access to sufficient inspection equipment, such that the parameters specified on the manufacturing documentation can be checked and recorded during each manufactured batch of components Calibration This inspection equipment shall be maintained and calibrated. This calibration shall be traceable back to the national standard Reports The supplier shall keep records of inspection. These records shall be available for Omnipless review. Suppliers should be able to supply inspection reports with deliveries. The frequency of this reporting will be dependent on the type of product, and will be identified on the drawing. A certificate of conformance shall be supplied with each delivery. This certificate should detail the following as a minimum: o Omnipless PO number. o Drawing issue to which the components were manufactured. o The quantity of components delivered. o The level of inspection applied. o The availability of an inspection report Inspection Levels If the number of components that are to be inspected per batch is not explicitly identified by Omnipless, then the supplier shall use a standard procedure for determining the level of inspection. This inspection level should be justified by the supplier using statistical data Maintenance of Records Records created and controlled by suppliers are specified in the Terms and Conditions for the purchase of goods and services, including the retention of these records as well as the actions required prior to the disposal of these records. Form #: 875-A0051 Issue 2.0 PAGE 7 OF 11

8 13 Finished Goods 13.1 Storage Finished goods stored at the supplier shall be stored in a manner that prevents degradation of the product. Storage procedures should be documented. These goods shall to be clearly identified by part number and drawing issue Packaging Finished goods are to be packed for delivery to Omnipless. This packaging shall protect the contents during the processes of normal handling and storage. The packaging method shall be documented to ensure consistency Reports The supplier should maintain records for each delivery to Omnipless: o Time (No of days early/late) o Quantity delivered vs. quantity requested o Customer returns/rejects 13.4 Marking Packages shall be clearly marked to allow for quick and accurate identification at Omnipless. Packages should be marked as follows: Each package is to be marked with a printed label approximately 150 x100 mm in size, with the following information: i. Omnipless Part number ii. Issue of component iii. Number of sheets/panels (may not be applicable) iv. Number of individual components v. Manufacturer vi. Omnipless Purchase Order Number ****Please Note: Omnipless will in future be requesting this information to be in both human readable and barcode format. This will facilitate receiving and picking using bar-coded systems. An example is shown on the next page: Form #: 875-A0051 Issue 2.0 PAGE 8 OF 11

9 Part Number 478-A1234 Issue 1.3 Number of sheets/panels 20 Manufacturer METALGRAPHO Number of Components 320 Order number Space at least 90mm x 30mm for Omnipless Goods Receiving Number Label Example of marking of packages 14 Returned and Non-Conforming Goods The supplier shall have a procedure in place for handling and rework of returned and non-confirming goods. This procedure is to ensure: o The returned and non-conforming goods are to be kept separate and clearly identified so as not to be mixed with normal production. o The reason for the non-conformance is to be investigated, corrective action taken to avoid the recurrence of the problem, and containment actions taken to limit the extent of the problem. o Records of the reasons for non-conformance are to be maintained for the purpose of identifying trends. These records are to be made available on request to Omnipless. o The supplier is to provide a rapid-turn-a-round policy for goods returned for rework. This rework is to be treated as a higher priority than all new work. 15 Rework and Repair Procedures shall be in place for the rework and repair of non-conforming product, either identified at the supplier, or returned by Omnipless. o Rework should be done in accordance with a written instruction. o Repair shall be done in accordance with a written and Omnipless approved instruction. 16 Corrective Actions The supplier shall implement corrective actions to prevent the recurrence of non-conformances. These corrective actions should be documented. A structured approach should be followed for analysing the non-conformance and implementing a corrective action, and then confirming the effectiveness of the corrective action. A log of the progress of each of these corrective actions should be maintained. When requested, the supplier shall provide Omnipless with written progress reports on the implementation of corrective actions. Form #: 875-A0051 Issue 2.0 PAGE 9 OF 11

10 17 Revision Control Procedures shall be in place to control the revision status of: o Omnipless supplied documentation o Supplier generated documentation, including the job card o CNC programmes and manufacturing software These procedures shall include a check to relate the issue status as referenced on the Omnipless PO to the manufacturing documentation. 18 ESD Requirements Whenever a supplier handles or processes ESD sensitive assemblies, the following workmanship standard shall be complied with: o JESD625-A, Requirements for Handling Electrostatic-Discharge-Sensitive (ESDS) Devices. Staff that handle and work with ESD sensitive components and assemblies shall also be trained to the requirements of the above workmanship standard. 19 Risk The supplier shall take steps to mitigate production risks. Such risks may be: o Backup of PC records o Off-site record keeping for critical documentation and software o Ensuring sufficient training of personnel such that the manufacturing process is not dependant on particular individuals Process risks should also be analysed and made available to Omnipless. These risks should include: o Material supply o Equipment availability o Personnel resources o Transportation o Financial resources 19.1 FMEA The supplier should implement and maintain an FMEA process in order to identify and control risks associated with the manufacturing process. The FMEA should be updated with information from any failures, either found at Omnipless, or within the supplier s process. Form #: 875-A0051 Issue 2.0 PAGE 10 OF 11

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