22.7 Product Realization


22.7 Product Realization

7.1: Planning for Product Realization

As previously discussed, Growth's president and CEO is responsible for the annual development and publication of the business plan, which is the framework within which the quality objectives, quality plans, quality policies, and changes to such activities are formulated as part of Growth's continual improvement directives.

Growth uses a hierarchical documented system of policies, processes, procedures, and forms to control the product realization activities. For example, software planning includes but is not limited to design documents, functional specifications, and quality documents to verify that the functional specification has been met. The process documents for this purpose are displayed in Figure 22.1.

Planning Output The product realization process is driven by both forecasts and directly received customer purchase orders. Output from this set of inputs is a combination of MRP reports and spreadsheet plans and schedules constructed by the manufacturing supervisors of planning and scheduling and approved by the vice president of manufacturing.

Procurement The acquisition of major capital equipment, new processes, and specially skilled employees is the responsibility of department managers and requires approval by the president.

Compatibility Growth employs design and documentation reviews to ensure that new products are manufacturable. A combination of program management/project management teams during design and the use of a continuing engineer during the production start-up phases ensure the effective transfer of new products into manufacturing. Process engineers are then used to maintain the production lines.

Installation Installation guides are provided to customers so that they can effectively install Growth products into their systems. Developer's guides provide information for developers writing software applications and software libraries such as microsoftware plus have resident software library references.

Updating Design engineering in conjunction with quality assurance is responsible for updating, as necessary, quality-control procedures, inspection and testing techniques, and the development of new test instrumentation.

Test Equipment Design engineering has the primary responsibility of designing and implementing any measurement equipment that exceeds state-of-the-art specifications. Such equipment must be available prior to production release and be clearly identified in the project plans.

Verification and Validation Design engineering is primarily responsible for the functions of verification and validation at scheduled stages in the product design plan. Upon release to production, quality assurance imposes verification and reliability activities on the product at all stages of manufacturing.

Standards and Codes and Workmanship Standards The Standards and Codes Procedure lists all of the regulatory and statutory requirements imposed on Growth's products [e.g., ISO 9000 Standards and applicable guidelines; institute for interconnecting and packaging circuits (IPC) workmanship standards; and the CE mark]. The procedure includes a master list that defines the standards and codes used; the responsible employee; how they are kept current; and where they are located. The internal design standards are also included in this procedure. Standards.Doc

Workmanship standards in the form of a series of IPC documents and reference manuals are provided to manufacturing. All manufacturing personnel are required to attend and satisfactorily complete a certification program based on IPC Standards.

Inspection and Testing Process Inspection and testing processes at Growth are created, controlled, and recorded by quality assurance and include reliability testing at accelerated temperatures over extended test times. The vice president of quality assurance is responsible for all inspection and test procedures at Growth. The primary document for this activity is contained in the document entitled "Inspection and Testing Processes." InspectTest.Doc

Product Quality Objectives and Requirements Refer to Table 22.1 for typical product objectives used to ensure a high level of product quality and performance.

Records Refer to Section 4.2.4 for a more detailed discussion of the records maintained by Growth to confirm that product performance meets customer requirements.

7.2: Customer-Related Processes

7.2.1: Determination of Requirements Related to the Product

Process The sales and marketing procedures are contained in the document entitled "Sales and Marketing Process." The vice president of sales and marketing is solely responsible for the content and accuracy of this document (inclusive of Section 7.2.2). SandMProcess.Doc

Determination of Customer Specifications In addition to sales to customers based on published brochures and price lists, sales and marketing program managers and design engineering project engineers establish direct contacts with customers in order to determine customer specifications. The functional specifications include all statutory and regulatory requirements. In those cases where the customer has inadvertently missed a specification that impacts form, fit, function, safety, or reliability, Growth negotiates such specifications into the functional specification.

For direct sales, a combination of sales orders and the customer's purchase orders are used to clearly define delivery requirements and warranty conditions. Customer service manages all after-sales activities, which includes returned goods and service contracts. Service contracts require the customer service manager's approval.

7.2.2: Review of Requirements Related to the Product

Forecasts The vice president of sales and marketing prepares a rolling monthly forecast for review with the top managers to ensure both hardware and software product availability and to meet contract or accepted order specifications.

Standard Products The president has final review authority, and the vice president of sales and marketing publishes Growth's standard price list. PriceLists.Doc

Standard off-the-shelf products are quoted by the sales staff by discounting the published price lists. Any nonstandard discount requires the approval of the vice president of sales and marketing.

Custom Products Custom quotes and customer contracts that require special product or pricing changes are reviewed and approved by the GEMT to ensure that Growth has the proper financial, marketing, engineering, quality assurance, manufacturing expertise, and capacity to take on the project.

Review of Customer Specifications Growth's sales staff, either at corporate headquarters or in the sales field offices, is required to review all written and verbal quotes with the customer and/or prospect base to ensure that customer specifications are clearly addressed.

New Products New opportunities for products—either hardware or software, solicited either by internal referendum or from the external market—are reviewed by the vice president of sales and marketing and presented to the GEMT to make the final decision on acceptability. The vice president of design engineering cannot accept a new project without this review and approval.

Verbal Orders Before a verbal purchase order can be accepted, the order must be documented by the sales staff, and, as with any written purchase order, the staff must ensure that the product specifications and pricing are correct.

Conflicts Growth's sales staff, both corporate and in field sales, have the responsibility and authority to resolve any issues in contracts, to resolve order discrepancies, and to raise such issues to whatever level of authority is required.

Amendments Sales and marketing personnel have the sole authority to amend orders regarding changes to written contracts. They must notify all of the affected departments in writing and manage any subsequent activity, particularly when a new product effort is involved. In all cases of amendments, a new sales order is opened.

Records Quotes are dated and stored by the sales staff. If a sales manager for a specific region is unavailable, another member of the staff has the authority to resolve any issue that might arise. All pertinent verbal and written correspondence with Growth's customers is dated and stored locally. Quotes are filed electronically. Records also include (but are not limited to) sales orders, customer purchase orders, sales acknowledgments, memos, and customer specifications.

7.2.3: Customer Communication

Product information is supplied to customers by means of product brochures and advertising managed by the vice president of sales and marketing. The manner in which inquiries, contracts, order handling, and contract amendments are managed is covered in Section 7.2.2 of this manual.

Customer feedback is obtained via customer surveys coordinated by the manager of direct sales; returned goods analysis, by the manager customer service; and management of customer complaints, by the vice president of quality assurance. The specifics of customer-complaint analysis are to be found in the quality-assurance manual. QAManual.Doc

7.3: Design and Development

Design Flow Growth's overall product design protocols cover six stages, and this concept is shown graphically in Figure 22.6. DesignEngProcess.Doc

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Figure 22.6: Product design guidelines.

Guidelines Growth maintains documented and control procedures throughout the life of the product. A detailed description of each stage in the process is located in the hub document entitled "Hardware and Software Development Guidelines." H/Wands/WGuidelines.Doc

7.3.1: Design and Development Planning

Product Management Products are designed under a program manager and project engineer protocol. The program managers are assigned by the vice president of sales and marketing and the project engineers are assigned by the vice president of design engineering. The project engineers are assigned to programs based on their expertise in hardware or software and each project engineer is required to form a cross-functional program team and specify clearly the authority and responsibility of each team member.

Program Plans The team creates the program plan, and the program manager is responsible for all administrative activities, which includes maintenance of the program plan and the program files. The vice president of design engineering in the role of chief engineer approves the final plan after an initial design review. Each plan includes specific activities related to design review, validation, and verification of both hardware and software tasks.

Communication The program manager schedules weekly team reviews to monitor the use of program resources and to maintain a companywide perspective on the product's development. It is common to invite technical specialists from outside the team to help resolve design issues. Variances from plan are elevated to the chief engineer who either approves the variance or requires that an appropriate corrective action be taken.

Resources The vice president of design engineering responds to requests by the program manager for the necessary engineers, equipment, facilities, and support personnel.

Updating The program manager updates each design plan periodically based on design review, management reviews, or status meetings.

7.3.2: Design and Development Inputs

The program manager and project engineer are responsible for the functional specifications based on various internal department and customer inputs and on Growth's decision of the product definition. The functional specification includes all statutory and regulatory requirements (e.g., use of the CE mark) and requires the final approval of the chief engineer.

The product proposal results from this specification, and its scope and complexity is proportional to the program's cost. Any ambiguities or conflicts that result from the functional specification are brought before the chief engineer for resolution and for approval of completeness.

7.3.3: Design and Development Outputs

The chief engineer is required to ensure that the final functional specification agrees in detail with the customer's requirements and only then approves and releases the document.

Upon release of the final functional specification, the design team develops the user's manual, which contains instructions for any special handling procedures that may be required (e.g., ESD handling instructions) and product maintenance. In addition, diagnostic test procedures are developed by the project engineer to verify and validate the product prior to production handoff.

Additionally, the design team establishes the technical file, which is part of the transfer to production. The technical file supplements the design history file and contains (among other items) the bill of materials, production work instructions, servicing procedures, product acceptance criteria, and product characteristics essential for safe and proper use. This information is designed to enable purchasing, production, and customer service to appropriately manufacture and service the product.

7.3.4: Design and Development Review

The program manager schedules design reviews into the program plan based on the complexity of the program and keeps the minutes from these reviews in the design history files, which form a part of the technical file. Several types of reviews are scheduled, which include technical reviews to define design, software code, algorithms, and production and manufacturability, as well as marketing and sales reviews to ensure that the program will meet the customer's changing needs in a dynamic marketplace. Appropriate guests are added to the design team as required to cover specific technical and/or marketing issues.

The minutes specify both hardware and software problems, and team members are assigned to analyze and offer solutions to such problems. Each design review includes a progress evaluation of such assignments.

7.3.5: Design and Development Verification

Project engineers test all new products against the final functional specifications as a normal part of the project plan. In addition, all hardware products are verified before release into production by means of a final prototype build and test, to ensure that all supporting documentation for production is available and correct.

Software engineers continuously test, debug, and verify software code as a normal part of the design process. In addition, all software products are verified before release into production by means of a verification copy of the software to ensure completeness of the production transfer package.

The program manager and project engineer are jointly responsible for performing and documenting the verification process and its results and the completeness of the design history files in this regard.

7.3.6: Design and Development Validation

All hardware and software products are validated before release into production to ensure conformance to the final functional specification, which includes all customer requirements. This process requires a system-level test strategy using a typical customer's system. In certain situations, the customer may ask to be present and validate acceptance through their signature.

The responsibility for performing and documenting the validation testing is jointly held by the program manager and the project engineer, who are also required to include a complete record of the activities in the design history files.

Transfer to Production A continuing engineer moves with the project from pilot line runs into forward production, and then remains with the program until manufacturing engineering phases in. An ECO is used for this transfer.

7.3.7: Control of Design and Development Changes

Design changes that result in variations from the functional specification are reviewed by the chief engineer for approval. The change, or rejection of the change, is documented in the design history files by the program manager. The chief engineer has the discretionary authority to call a more general management review if required.

An ECO, maintained by the engineering documentation manager, is used to release products to production, and once the product is released any changes are made via the ECO process.

Part of the ECO function, which contains a history of actions taken to assess change validity, is to make certain that all changes have been properly reviewed, tested to verify the efficacy of the change, and validated against customer-specific requirements, as appropriate, particularly with regard to the impact on component parts and product already in the field.

7.4: Purchasing

7.4.1: Purchasing Process

The purchasing documentation includes a set of procedures and specifications required when procuring subcontractor services, piece parts, and noninventory and other items. This information is contained in a controlled three-ring binder entitled "Purchasing Manual" maintained by the purchasing manager. PurchManual.Doc

Incoming Inspection All raw material received from vendors is verified by receiving and sampled by quality control to ensure conformance to specification. Product that does mot meet specification is placed in material review board (MRB) for disposition. In addition, printed circuit boards require a certificate of conformance by the contract vendor with deliveries. In cases of immediate or urgent production requirements, a waiver procedure is used to identify material released for production prior to the issuance of a complete documentation package.

Evaluation of Subcontractors Growth initially selects its subcontractors on the basis of site visits, questionnaires, quotations, and references. In all cases, a long-term commitment to quality assurance, especially in terms of ISO 9000, is sought with its key customers.

After selection, site quality audits when appropriate are conducted jointly by the quality-assurance department and manufacturing department to maintain an ongoing partnership relationship. In addition, periodic evaluation reports, which inform the vendor of its progress against on-time delivery, performance, and quality, are published by the purchasing manager.

Printed circuit board design houses are specifically evaluated by the vice president of manufacturing and the vice president quality assurance. Certificates of compliance and/or analysis are required from the printed circuit board design house.

The purchase of noncritical components is entirely at the discretion of the buyers.

The records of approved subcontractors are maintained in the approved vendor list (AVL) maintained by the purchasing manager. Subcontractors are either added or removed from this list through a continual evaluation process documented by the purchasing manager.

7.4.2: Purchasing Information

Growth's purchase orders (POs) include the PO number, the date the order was placed, the PO type, the date the PO was last changed, the quantity ordered, the part number and its description, the vendor, the price, and the required quality standards, when appropriate. The quality requirements of both material and personnel are supported by attached engineering drawings and specifications.

The POs are controlled in a numbering sequence that is kept in logs controlled by the buyers. Two different types of POs are used to purchase either inventory or noninventory items. All inventory POs require the signature of the purchasing manager prior to release. Noninventory orders are signed off by the buyers.

7.4.3: Verification of Purchased Product

Growth performs source inspection, when appropriate, at the subcontractor's facility. In those situations, the purchasing manager is required to formally alert the vendor prior to the visit and develop a protocol that establishes the conditions under which the source inspection can be terminated and future shipments can be released.

If agreed to contractually, Growth allows its customers—or their representatives—to inspect its product at either Growth or at the subcontractor's facility.

Growth neither uses the positive results of such an inspection as evidence of its effective vendor management, nor feels that it is a means of releasing Growth from always supplying acceptable product to its customers—nor that it affects the potential rejection of such product by the customer.

7.5: Production and Service Provision

Growth's manufacturing process is based on 10 stages as graphically demonstrated in Figure 22.7 (refer to the process document entitled "Hardware and Software Manufacturing Processes"). MnfgProcess.Doc: Customer Service documentation is found under this icon: CustSvc.Doc:

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Figure 22.7: Product manufacturing process.

7.5.1: Control of Production and Service Provision

Production Control The vice president of manufacturing oversees the functions of production and materials control. The production control manager and the materials manager analyze the sales forecast and inventory status and produce production schedules that are approved by the director. The schedules drive the procurement process. Floor documentation released by the control team includes a process control document, a color-coded assembly drawing, required inspection visual aids, and special mechanical drawings as required. Any special characteristics of the product are included in this documentation set and coded as necessary.

Continuing engineering makes sure that production equipment meets the product manufacturing requirements with respect to both accuracy and precision. The vice president of manufacturing is responsible for capacity and throughput requirements and authorizes the movement of processes and product-related manufacturing equipment onto the production floor.

Monitoring and Control Growth uses a series of software-based tests that display various pixel image patterns for visual definition, and test procedures are developed by design engineering for specific product lines.

The controlling process document is the process control document (PCD) ( PCD.Doc), issued by engineering services for each assembly built. This document contains both customer documentation and Growth's process revision control system to ensure that the current product is built to the correct revision. This document fully defines each process step that an assembly must undergo. These documents are prominently displayed in the materials, surface mount, through hole, quality control, and other areas as required when an assembly is in process. This document also identifies all required tooling, programming, and special instructions as necessary. In addition, any component substitutions or special material preparation is included.

The PCD document requires sign off by materials, process engineering, manufacturing, quality, and when appropriate test supervision. The revision levels are controlled and updated under the ECO process.

Each process step is monitored and, when applicable, statistical techniques are used to measure process variables to ensure that the process is in control. Customer quality requirements have absolute precedence.

Workmanship Functional test suites are run against all hardware products to ensure that the products are functionally correct. Video quality is verified by running a series of software tests. IPC standards are used where applicable in the assembly process.

Nonrepetitive Processes Nonrepetitive processes, such as prototype builds, depend on very close customer interfacing to define levels of process controls. Special instruction sheets are issued as part of the process control document, when applicable.

Records and Nonconformances Any material or assembly found in nonconformance is promptly identified and segregated as such. Prompt action is then taken to bring the material back into conformance or disposition according to the protocols for the control of nonconforming product as discussed in Section 8.3 of this manual. The records of acceptance and/or rejection, which clearly show the responsible inspection authority, are maintained in their respective areas (i.e., either in materials or quality-assurance files).

Notification of products on hold is identified by a QC verbal communication to all affected areas. Any changes required to remove the product from hold is done through the ECO process.

All product that is shipped from Growth meets all required specifications. The shipper is required to verify the inclusion of all product and related components into the shipped package, including software and documentation as noted on the pick ticket for the order. The shipper validates the pick ticket with date shipped and their initials.

Software For required software, the software files to be replicated are revision controlled by means of the ECO process and its associated part number. Error checking is built into the replication process.

Records All records are maintained by either quality assurance or materials, as appropriate.

Customer Services Under the direction of the customer service manager, Growth provides various service functions to its customers, which include the following:

  • Warranty repair;

  • Out-of-warranty repair;

  • Extended service contracts (hardware and/or software);

  • On-site warranty support;

  • Custom hardware or software services;

  • Field implementation of ECO procedures for software and hardware;

  • General servicing.

Warranty Repair Growth provides warranty terms and conditions as part of the general sale. Warranty repairs and mandatory ECOs are handled through the return material procedure (RMA) procedure.

Out-of-Warranty Repair Repairs or ECOs to hardware or software products that are out of warranty are handled through the RMA procedure.

Extended-Service Contracts At the discretion of sales and marketing, Growth offers extended-service contracts that may be for hardware or software products.

On-Site Support Reporting, verification, and tracking of on-site support issues are the responsibility of the customer service manager. Service reports are in the form of memoranda and are completed on site.

Spare Parts When appropriate, Growth supplies spare parts to minimize customer down time. The materials department is responsible for the activity.

Custom Services Custom services above and beyond Growth's normal servicing policy may be negotiated in an individual contract with the approval of the director or sales and marketing.

Field Implementation of ECO Procedures The customer service manager oversees the implementation of ECOs that affect hardware or software product in the field. At the discretion of the customer service manager, field exchanges in accord with the RMA procedure may be used to implement ECOs.

General Servicing The general servicing that Growth provides is defined as verbal and written technical support, historical and analytical information, and other assistance in resolving technical issues.

7.5.2: Validation of Processes Production and Service Provision

Special production processes, such as conformal coatings, are closely monitored and conform to strict qualifying procedures as defined by customer requirements. Records are maintained by the vice president of manufacturing and are related to the qualified process used, the qualifications of the personnel, and the qualification of specific equipment used. Revalidation of the processes and procedures as well as requalification of personnel is performed either annually when there is continuous production or as required for short runs.

In addition, because image quality is measurable on both a quantitative and subjective level, acceptance testing of product is performed by qualified test operators using calibrated test equipment. As with the special production processes, pertinent records are maintained by the vice president of manufacturing for this purpose.

7.5.3: Identification and Traceability

Growth uses product identifiers (PIs) to define the sales and marketing product name that may not be the same as the part number. The vice president of sales and marketing maintains a list of the approved PIs. All hardware and software documentation for a given product clearly states the PI.

The vice president of manufacturing is responsible for determining the serial numbers of all hardware and software products, and all products are labeled with either the PI or the part number and its revision level.

All hardware products are labeled with their serial number, and all software products are labeled with their release date. Software products are identified and traceable by part number and revision level. The vice president of manufacturing maintains a database that tracks board history.

Hardware documentation includes information needed to trace and record all printed wiring assemblies, box, and system-level products by board type and manufacturing lot. This information includes BOM, build, and test information.

A manufacturing resource planning (MRP) system is used to identify and track the progress of units as the lot moves through the manufacturing process. All product is followed and tracked by job number. Job process tags are attached to all product for use in identifying, tracking, and tracing the product through the factory. Each operation in the process is verified by the operator's initials. Different colors are used to differentiate standard product from returned product.

Inspection and Test Status When Growth receives components, printed circuit boards, and assembled materials, the receiver verifies and dates the packing slip. Upon receipt, quality assurance verifies the assembled material's inspection and test status.

Job tags that define job numbers and individual board serial numbers are used to monitor manufacturing and inspection process traceability on all boards processed.

All manufacturing and test processes are initialed and dated on the tag by the operator performing the specific process. All inspection processes are initialed and dated on the tag by the inspector performing the specific inspection.

Inspection status is further supplemented with the use of unique inspection stamp markings directly onto the surface of the printed circuit boards. The stamps use an indelible ink that was selected to withstand all cleaning processes. Either inspection or test stamps are marked on the assemblies as required before shipment.

The status of software is determined by the presence of the label that includes the appropriate part number and revision. Software products clearly indicate revision levels in accordance with documented numbering methods defined in engineering document control procedures.

Growth's in-house quality test records that define the hardware status are maintained in the first pass yield database. This database tracks boards by the product name, build lot, and serial numbers. The Growth RMAs database is used to record any nonconformance of both hardware and software products.

Physical locations in the production area for work in process and finished goods are also used for identifying the status of assembled product. Rejected or failed material is marked with a nonconformance color-coded tag, specific to the type of nonconformance. Products are required to be fully tested and burned in prior to shipment. If a product is shipped that does not meet full specification, a mutual agreement is established between sales and the customer. A hold tag is used to identify any product that may be placed on hold for any reason. Any subsequent changes to product are identified via the ECO process.

7.5.4: Customer Property

Customer-owned (supplied) materials at Growth consists of RMAs and miscellaneous engineering test systems and development equipment used in the design validation process. The RMAs are controlled by the RMA procedure and tracked by customer service that has the primary responsibility of responding effectively to customer returns.

Customer service also provides the required management for field exchanges, loaners, or evaluation units that are handled in the same manner as product returned for repair or refurbishment.

Miscellaneous test systems and development equipment is maintained and tracked by local area engineering managers.

Any customer-owned equipment or material that is lost or damaged in any way is reported to the customer service manager for disposition and corrective action with the customer.

7.5.5: Preservation of Product

Handling All Growth employees are trained to follow Growth's ESD practices and the effects ESD can have on Growth's products. Quality assurance is responsible for the maintenance of the ESD equipment and documentation. The adherence to these policies is the responsibility of the department managers and all employees.

Storage Receiving and quality assurance receive and approve all products that are shipped into the facility. Once the products are verified and received, they are put into a secured stockroom for storage. The stockroom supervisor is responsible for handling the transactions and activity in and out of the stockroom to prevent any damage or misplacement of components.

Parts and finished goods leaving the stockroom area must be signed out on a sign-out worksheet. The stockroom is organized by Growth's part numbers. The inventory control supervisor monitors these components on a regular basis.

Packaging Procedure Growth has a specific shipping procedure that must be followed when shipping customer products. The manufacturing process directs the shipper to the necessary documentation and equipment. The manufacturing processes describe the specific packing material that is used. These materials include static shielding bags for all board-level product. When requested, Growth packages product according to special customer specifications. The materials being used for packing are monitored by the shipper/receiver and the appropriate buyer.

Preservation There are separate areas designated for finished goods, works in progress, raw components, customer-owned material, and MRB. These areas are closely monitored by quality assurance. Growth adheres to shelf-life requirements where applicable.

Delivery Growth uses a segregated secured stock room for finished products that have passed final test and inspection. These products are available to ship for customer orders. Products are shipped free-on-board (FOB), the Growth Corporation, St. Louis, MO. When the customer does not specify a delivery method, Growth uses the most expedient, cost-effective, and quality-assured method. If there is a contractual agreement, Growth extends its protection responsibility to include delivery to destination

7.6: Control of Monitoring and Measuring Devices

Monitoring and Measuring Device Protocol Growth requires the calibration and maintenance of equipment used to either make absolute measurements or accept or reject product, e.g., oscilloscopes, multimeters, photometers and temperature probes according to Growth's Metrology Manual. Only inspection, measuring, and test equipment (IM&TE) used for monitoring and measuring processes and product, that requires calibration, are so marked. Metrology.Doc

Testing/Software Test protocols are initially designed by design engineering. They are released as part of the release package to manufacturing, where they are maintained under ECO control. All software is validated before use by means of both golden boards and diagnostics, and the software integrity is maintained under ECO control.

Testing/Hardware Test hardware used by Growth for development and production is maintained and/or calibrated by design engineering.

Measurement Uncertainty Calibrated equipment has documented tolerances. Where applicable, measurement uncertainty is determined by design engineering.

Records Calibration information is maintained by the director of quality assurance. It includes the definition of nationally and/or internationally recognized standards, equipment type, unique identification, frequency of calibration, calibration method, acceptance criteria, and actions required if equipment becomes uncalibrated. This also includes any calibration or maintenance falling outside the specified calibration intervals.

Technical Data If contractually required, Growth makes available to a customer all technical data related to the specific measurement equipment.

Control Responsibility Either the equipment manufacturer or design engineering is responsible for determining the accuracy and precision of any purchased testing or measurement system. The required accuracy and precision of the equipment is established either as a part of the selection process or when otherwise specified by the customer.

Calibration Calibrated equipment is visibly tagged or labeled, indicating the last calibration date and expiration date. This label also has the authorized signature of the person that performed the calibration.

Calibration information is maintained by the director of quality assurance. It includes the definition of nationally and/or internationally recognized standards, equipment type, unique identification, frequency of calibration, calibration method, acceptance criteria, and actions required if equipment becomes uncalibrated. This also includes any calibration or maintenance falling outside the specified calibration intervals.

Standards All calibrated equipment is calibrated against international or national standards, as appropriate. In some cases, internally created test protocols are used as test standards based on actual applications. Calibration plans are managed via logs that are maintained by quality assurance to indicate calibration cycles and frequency.

Calibration labels are used on all required IM&TE to alert operators that calibration is adequate or due. If calibration is overdue, operators are to immediately alert quality assurance and suspend use of the equipment until calibration is completed.

All equipment is sent out for independent calibration to companies selected by their capability with regard to using appropriately known standards. Quality assurance maintains logs of all of these transactions. A Paradox database file, CALIBRAT.DB is maintained, which lists calibration status for all equipment on a calibration cycle.

Invalidation Any product that has been validated with uncalibrated equipment is subject to a documented joint review by quality assurance and the director of manufacturing. The corrective action protocols are used when required. However, it is the responsibility of each operator to check equipment calibration status prior to each measurement. Appropriate actions are taken to correct any situation in which measurements were made with equipment found later to be out of calibration. Such actions include notifying the customer, retesting product, product recall, waivers, and rework.

Conditions All IM&TE requires room-temperature operation only and no special handling other than normal maintenance as prescribed in the equipment's operation manual.

Safeguarding Calibration labels and/or seals are placed in an appropriate location to prevent adjustments. If the label/seal is broken, the calibration becomes invalid, and the equipment may not be used until recalibrated. Operators are not allowed to make any adjustments to equipment. All adjustments are under the control of quality assurance.

Subcontractors IM&TE used by Growth's assembly houses, when required, is consigned to the house and maintained using Growth's calibration processes.




ISO 9001(c) 2000 Quality Management System Design
ISO 9001: 2000 Quality Management System Design
ISBN: 1580535267
EAN: 2147483647
Year: 2003
Pages: 155

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