Quality System

Scope

Quality System Elements

Element #1: Quality Management Systems

Quality System Manual
The supplier shall maintain an up-to-date manual describing its quality policies, system elements and objectives, and associated procedures. This manual shall include a current organizational chart representing the supplier's formal management structure. This manual shall be controlled by a formal means to assure it is current.

Designated Quality Official
The supplier's upper management shall include an appointed individual(s) who manages the product quality control and quality assurance system. This individual(s) must have the authority to advise manufacturing restraint or re-direction to non-conforming product conditions at the earliest time and administer preventive and corrective action plans when needed.         Top

Element #2 - Procedures (Process Documentation)

Quality System
The supplier shall develop and maintain documented procedures covering all phases of its quality system. Procedures shall be available to those who need them and for review by ESI representatives.

Inspection and Test Instructions
The supplier shall prepare and utilize documented inspection and test instructions to verify in process or finished product quality levels and assure optimum control to established standards. The supplier's inspection and test instructions and corresponding reports should consist of:

1. Control points or stations within the manufacturing process.
2. Product characteristics to be inspected.
3. Methods of measurement.
4. Frequency of observations.
5. Sampling Plans.
6. Acceptance/rejection criteria.
7. Nature and frequency of non-conforming conditions.
8. Material disposition as required.
9. Corrective action as required.
10. Other techniques normally utilized.

Customer Purchase Order Control
Purchase orders or contracts from ESI shall be reviewed by the supplier to ensure that they are understood, agreed to and that the supplier has the resources to meet product performance, quality, quantity, and schedule requirements. Procedures for purchase order or contract processing, approval and amendments shall be documented. Records of customer purchase orders or contracts or amendments shall indicate that the supplier and customer have reviewed them. The supplier shall promptly communicate any changes to appropriate departments.

Procedures
All documents affecting product quality shall be:

1. Reviewed and approved by appropriate authority prior to use.
2. Revision controlled to ensure the use of current and accurate issues.
3. Distribution controlled to ensure that all copies of documents affecting product quality are current and accurate.
4. Available to those who need them.

Training
The supplier shall define and document the training, skills and abilities required to achieve required product quality and provide for these needs. Records of training shall be maintained to show that those affecting product quality have appropriate skills, abilities and training.     Top

Element #3 - Measurement Systems

Measurement Equipment
The supplier shall provide and maintain the necessary inspection and test equipment to assure the collection of accurate and reliable product measurement data and conformance to specifications. This equipment, mechanical and electronic (i.e. digital, analog/dial optical/vision, moire fringe/diffraction grating, hard gages, fixtures, templates, test stands, etc.) shall be checked at appropriate established intervals to assure continued accuracy traceable to the National Institute for Standards and Technology (NIST).

To the extent necessary, a documented schedule, procedure, and record of calibration verification shall be maintained for the serviceable equipment. Unserviceable equipment will be identified and contained appropriately. Measurement equipment shall be available for review and use by ESI representatives.

Note: The inability to perform required inspection and testing within the confines of its own facilities does not relieve the supplier of the responsibility to verify conformance to specifications. In such cases, testing services must be procured by the supplier from qualified testing sources. ESI does not provide measurement equipment for supplier use; however, any existing gage design specifications will be provided upon request.

Advanced Measurement Equipment Analysis
The correlation of measurement data between supplier and ESI may not always be dependent on the accuracy of measurement equipment alone. Repeatability and reproducibility may play an important role in determining why one measurement instrument provides different results than another.

When correlation of measurement data cannot be confirmed after calibration check, an advanced equipment study can be conducted to quantify and statistically analyze repeatability and reproducibility to determine the level of equipment stability.     Top

Element #4 - Purchased Material Control

Acceptance of Purchased Material
The supplier quality system should include a quality management function to accomplish the following as a minimum:

1. Receiving inspection and test of incoming purchased material. This includes documented inspection and test plans specifying product quality characteristics and associated AQLs, measurement methods, acceptance sampling schemes, and any special instructions for insuring each shipment of incoming material conforms to applicable specifications and required "customer organization" product quality levels. Resulting inspection and test results shall be recorded in supplier performance history files. Material will be physically identified with regard to acceptance status prior to production use.
   
   The original inspection and test data corresponding to sub-contractor material certification and used as single acceptance criterion shall be maintained on file and verified by documented periodic assessment of the purchased material.
   
   Physical and chemical test reports for raw material shall be maintained on file by supplier or sub-contractor.
2. Periodic evaluation of sub-contractor performance against established source selection and retainment policies and criteria.
3. Maintenance of a list of approved subcontractors meeting quality criteria.

Material Containment and Corrective Action
Non-conforming purchased material shall be physically identified and maintained in designated hold areas pending documented disposition and corrective action.

Sub-contractors will be notified of all non-conforming material conditions via corrective action request whereby cause, action, and date of effectively can be documented.

Material Certification Process
The supplier shall maintain material and part certification comparable to the requirements specified in Certification Process when deemed necessary by supplier or requested by ESI.

Customer Supplied (Consigned) Material Control
The supplier shall identify, control, store and use material supplied by ESI for inclusion in product per documented procedures. Any ESI provided material that is lost, damaged or unusable shall be recorded and reported to ESI Purchasing immediately per documented procedures.     Top

Element #5 - Manufacturing Process Control

Inspection and Testing
The supplier will routinely perform first and last piece inspection and testing as necessary to verify conformance directly after manufacturing process set-up, changeover, tooling change out, or machine adjustment.

The supplier shall perform continuous product inspection and reliability testing of designated product characteristics, both variable and attribute per documented procedures. Appropriate check points in the manufacturing process and statistical sampling plans will be established to ensure targeted acceptable levels of product quality and compliance with all applicable specifications. Only product that has passed all required inspection and testing may be further processed. Acceptance of product by any sampling plan does not relieve the supplier of the responsibility to ensure all parts meet specifications.

Statistical Process Control (SPC)
ESI is committed to the application of statistical methods and advanced problem solving techniques in the manufacturing process. The supplier that has yet to adopt these popular methods of controlling and improving manufacturing process output is advised to consider doing so. ESI recommends the supplier apply SPC as a minimum to product quality characteristics designated "critical." The supplier may be requested under purchase order Supplier Quality Requirements to provide real time SPC data in support of the certification process. If control charts are used, they are to be maintained and regularly reviewed for process improvement and control limits adjusted accordingly. ESI also requires that all Suppliers implement a formal, continuous training program in SPC, problem solving, and design of experiment.

Process Capability Studies
Process capability is a measure of the ability to consistently produce parts within specification. Process capability can only be determined when a process is in statistical control. The supplier may be requested to conduct process capability studies over a specific production time period on select "critical" quality characteristics. Some critical product characteristics contain extremely "tight" tolerance limits crucial to product form, fit, and function and may warrant a formal machine or process capability study to identify and quantify variability. 

In-Process Operating Instructions
The supplier shall develop and maintain documented operating instructions for each routine step or operation within the manufacturing process. Such instructions shall be available to the production employee during training and as needed to aid in process control and help minimize manufacturing errors.

Material Tracking
The supplier shall maintain a permanent record of routine and special steps or operations in the manufacturing process and of what material or parts were combined to complete the finished product. A process control flowchart shall be provided for each product illustrating workstations, production sequences, material flow, and control points/stations. Inspection and test status of product shall be identified throughout the production process. In-process material from receipt through shipping shall be adequately identified per documented procedures.

Lot Control System
The supplier shall maintain a system of lot integrity control in the manufacturing process to prevent diversion of in-process material from its lot. When splits of parent lots are required, the segregated quantity shall be appropriately identified to maintain traceability to the parent lot. Applicable inspection and test documentation shall be traceable to production lot quantities and dates. As required under special quality clauses, the supplier shall provide unique lot identification or serialization.

Equipment Preventive Maintenance
The supplier shall maintain a documented equipment preventive maintenance program to help ensure uninterrupted process flow and minimal downtime. This should include:

1. Schedules for planned downtime
2. Trend analysis
3. Documented maintenance procedures
4. Corrective action and repair when required

Final Inspection
The supplier shall maintain documented final inspection procedures for verification of finished product and packaging and for contingency purposes as needed.

General
The supplier's facilities should be clean and well organized with good housekeeping practices. Product flow should be uniform and efficient.

Electro Scientific Industries packaging and delivery requirements as well as any special handling, storage, product protection and/or preservation requirements shall be documented and implemented.   Top

Element #6 - Product Documentation and Change Control

Product Drawings
The supplier shall ensure all current Engineering Change Orders (ECOs), product drawings and specifications are maintained in active product and/or quality control files. When retained, obsolete drawings will be physically identified and segregated from active drawings and specifications.

Pending ECO levels on Electro Scientific Industries product drawings are identifiable by the un-circled ECO letter/number. This indicates the ECO is pending approval. Manufacture and testing of prototype, first article, or initial production units in accordance with pending ECO level drawings are permissible; however, any subsequent manufacture of production units is not. An ESI Product Deviation must be approved by the ESI Supplier Quality Engineer and the Program Manager before production parts are shipped to ESI.

Purchase Orders
Electro Scientific Industries purchase orders, documented contractual requirements, and associated change orders will be maintained on file by the supplier for at least four years after completion of the purchase order or contract.

This Standard 
ESI reserves the right to periodically revise or upgrade this standard to accommodate future innovations and the need for continuous improvement in a competitive marketplace. This will be an online (web-based) document, and extensive changes made by ESI will be communicated to suppliers.

This standard shall be promptly updated upon receipt of change notices. Such changes are to be integrated into the supplier's organizational activities and quality system on or before the change notice date. Feedback in the form of change notice questions, suggestions, and appeals shall be directed to an ESI Purchasing representative or Supplier Quality Engineer.

Record Retention
Unless otherwise specified, the supplier shall maintain all relevant product, processing and quality system records for a minimum period of five years. These records shall be readily available for review by ESI representatives. Quality records shall be identified, collected, indexed, stored and disposed of per documented procedures and protected from damage or deterioration.

Change Control System
The supplier shall maintain a documented system to assure that engineering changes and deviations, both supplier and ESI generated, are consolidated, documented, and reviewed internally by Manufacturing, Quality Engineering and other appropriate functions. The supplier is responsible for notifying ESI Purchasing of any self-generated changes affecting product quality, reliability, packaging, delivery or appearance.     Top

Element #7 - Non-Conforming Material and Corrective Action

Identification and Containment of Material
The supplier shall ensure non-conforming material is promptly and accurately quantified (includes purging in-process and finished goods inventory), clearly identified, and physically segregated in designated hold areas. A non-conformance and corrective action report shall be initiated for material review pending disposition and immediate corrective action.

Material Review System (MRS)
The supplier will maintain a material review system for prompt and effective disposition of material and immediate corrective action in the most practical and concise manner.

1. Material Disposition Categories
   Scrap. Non-conforming material deemed unusable and unable to economically rework or repair. This can apply to screening defectives from a batch of material and salvaging the acceptable. Scrapped material should, when practicable, be conspicuously and permanently marked to preclude subsequent use in production.
2. Rework/Repair. Non-conforming material subjected to a planned manufacturing process with documented instructions for restoring and verifying that all non-conforming characteristics have been restored to specifications. This can apply to screening and reworking/repairing the defectives from a batch of rejected material. All material must be verified by process control or inspection prior to use.
3. Return to Supplier. Includes corrective action from supplier.
4. Use as is. Includes deviations requested by the supplier and approved by ESI for material containing minor non-conformance determined to be fit-for-use. Corrective Action by process improvement or specification change must always follow.

Corrective Action (Applies to internal and external systems, processes, and products)

The best corrective action is to prevent problems before they occur. ESI encourages suppliers to be proactive and stress problem prevention in their quality systems. Electro Scientific Industries SQE will notify suppliers of all non-conforming material received via an 8D, 5-why Supplier Corrective Action Request (SCAR). The SCAR is to be completed and returned to the Supplier Quality Engineer within 10 working days. The supplier shall investigate the cause and effect of non-conforming material conditions, identify the problem, and implement the following two types of corrective action:

1. Containment. Containment action provides quick response to a problem without searching for root causes (i.e., immediate customer notification of inadvertent shipment of non-conforming material, screening defectives from a rejected lot, reworking material until problem is resolved, etc.). Containment action is to be reported within 24 hours of initial notification.
2. Long-term. Long-term action attempts to isolate and overcome root causes and should be geared toward effectively preventing the problem from recurring. The effectiveness of corrective actions should be verified and trends should show continuous improvement.
3. Information Feedback The supplier shall provide ESI Purchasing with immediate notification of inadvertent shipment of incorrect or non-conforming material.       Top

Element #8 - Quality Assessments

Quality System Assessment
The quality system assessment is an independent review to verify by examination of objective evidence that key elements of the quality system are developed, documented, and effectively implemented in accordance with specified requirements. Determining assessment parameters requires careful planning and comes from first determining assessment objectives. The parameters are then compiled on a check sheet.

The supplier shall conduct an assessment of its quality system annually using the qualification assessment report provided or provide an equivalent report (example ISO-9000/QS-9000/TS 16949) indicating requirements are being met. This assessment should be conducted by employees not having responsibility for the areas being evaluated. Corrective actions resulting from these assessments should be implemented, recorded and reviewed with upper management.

Assessments shall be documented, filed, and made available for review by ESI Purchasing and Supplier Quality representatives.

Product Assessment
The product assessment is an independent review used to determine the actual level of product quality. Assessment findings are indicative of quality system effectiveness and production quality. The product assessment randomly samples the output of manufacturing by examining products from finished goods inventory ready for shipment to customers. The implementation and effectiveness of corrective actions shall be verified and trends should show continuous improvement.

Production Process Assessment
The production process assessment is an independent review to determine the capability of a particular manufacturing operation. This is sometimes referred to as a process capability study but includes the assessment of operating instructions. Appropriate corrective action should be taken when deficiencies are found.

Assessments may be conducted on production processes during product development, first article samples, initial production runs, or any time the need arises to quantify variability.     Top

Element #9 - Continuous Improvement

Value Engineering
The supplier is encouraged to participate in the ESI Cost Reduction Program. Technical knowledge and industrial expertise puts the supplier at the forefront for reducing material, manufacturing, and handling costs and improving quality and reliability through process optimization techniques. Recommendations are welcomed for new product designs, improvements to existing designs, and better methods of material packaging, handling, and delivery.

Quality Cost Analysis
It is recommended that the supplier maintain a quality cost collection and evaluation process to help target resources contributing most to wasted profit and to target processes with the most potential for improving product quality, reliability, and customer satisfaction. An overview of quality cost categories follows:

• Failure Costs (Internal and External): Failure costs are associated with all things found non-conforming as well as the evaluation, disposition, and consumer-affairs activities of such failures. Included are all materials and labor involved.
• Appraisal Costs: Appraisal costs are incurred while conducting inspections, tests, and other planned evaluations used to determine material and product conformance to requirements. This includes information pertaining to procedures and processes. All documents describing conformance of the product or service are relevant.
• Prevention Costs: Prevention costs are the costs of all activities undertaken to prevent defects or mistakes in design and development, purchasing, labor, and other aspects of beginning and creating a product or service. This includes all preventive and measurement actions conducted during the business cycle.

Continuous Flow Manufacturing (Demand Flow) 
ESI encourages suppliers to adopt Continuous Flow Manufacturing methods, because they result in increased throughput, reduced inventories, increased inventory turns and reduced non-conformance costs. Emphasis should be placed on increasing value-added activities and reducing non-value-added activities.

Design of Experiments (DOE)
Industrial Designed Experiments are an excellent, cost effective tool for improving manufacturing processes. Designed Experiments are a branch of applied statistics dealing with planning, conducting, analyzing and interpreting controlled tests to evaluate the factors controlling product or process parameters. ESI supports the use of this and other statistical tools, when used correctly, to improve our suppliers' processes.

Process Control Plan
Process control plan provides an effective way for supplier and ESI to achieve consensus on quality planning for new products and review any system changes made thereafter.

Suppliers are to develop and submit process control plans, which describe the quality planning for a specific part or family of parts. These plans should cover all affected designated characteristics specified by Electro Scientific Industries. Plans include, but not limited to, all manufacturing process within the supplier facility and all sub-contracted material and services. Each plan must be approved by Electro Scientific Industries SQE upon the initial submittal and follow-up changes.

Proprietary process details included on the plan should be identified as such. On such occasion, supplier may reserve the right to maintain these plans at their facility subject to review by Electro Scientific Industries SQE.

Product Control Plan
Product control plan is a written documentation of those product parameters deemed necessary to control the quality of material/services supplied to ESI. The plan addresses dimensions, specifications, certifications and includes all designated key characteristics specified by a team of Quality Assurance Engineers from ESI.

Suppliers are to prepare, maintain and follow a plan containing, as a minimum, a similar requirement, when defining the control of supplied product/services to ESI.

Failure Mode and Effects Analysis (FMEA)
Suppliers are to take an active role in training and development of design and process FMEA techniques within their organization.

FMEA is a disciplined analysis, which identifies and examines the potential modes of failure, the effects of these failures, and the potential causes of failure. It also evaluates the occurrence, severity, and detection of the failure through a Risk Priority Number (RPN). FMEAs are used to eliminate or reduce potential failure modes and serve as the basis for providing effective follow-up and corrective/preventive action plans prior to mass production. RPNs of greater than 64 need to have identified appropriate corrective actions.

Quality Function Deployment
Quality Function Deployment is a method of translating customer requirements into appropriate internal company requirements at each product development phase: research and development, engineering, process design, manufacturing and distribution. ESI uses and promotes this approach and encourages suppliers to ensure that our requirements are understood so we can work together to meet them.

Robust Design
Products and processes that are relatively insensitive to normal variations and continue to produce consistent, acceptable results are said to be "Robust." Designed Experimental techniques, such as Taguchi designs, can be used to measure and improve the robustness of products and processes. Electro Scientific Industries encourages suppliers to develop and implement robust designs in their processes and encourages suggestions for improving the robustness of ESI parts, assemblies and products.

Concurrent Engineering
Products and the processes that produce them, that are designed together, as a complementary system, produce better overall results. ESI is willing to work with its suppliers as business partners to this end.

Process Potential Studies
Process potential studies assess the short-term influence on critical parameters emanating from the system consisting of the machine, operator, process and environment when the study is performed. Typically, 32 consecutive items are measured and the results analyzed. The capability index is then calculated. A minimum capability index (Cpk) of 1.33 is required to consider a process statistically capable.    Top