• -- QualitySystemManual - 02 Jul 2008

7. Product realization

7.1 Planning of Product Realization (Production Planning)

The organization plans and develops the processes needed for production of products. Production planning is consistent with the requirements of the other processes of the quality management system (see 4.1). In production planning, the organization determines the following, as appropriate:

• quality objectives and requirements for the product,
• the need to establish processes, and documents, and to provide resources specific to the product,
• required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance, and
• records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).
• The identification of resources to support operation and maintenance of the production facility.

The output of the planning is in a form suitable for the organizations method of operation.

NOTE 1: A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, is referred to as the quality plan.

Supporting Documentation

• Production Overview Flowchart
• Production Provision

7.2 Customer- related processes

7.2.1 Determination of requirements related to the product

The organization determines customer requirements before acceptance of an order.

The organization determines:

• requirements specified by the customer, including the requirements for delivery and post-delivery activities,
• requirements not stated by the customer but necessary for specified or intended use, where known,
• statutory and regulatory requirements applicable to the product, and
• any additional requirements considered necessary by the organization.

Note: Post delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.

Supporting Documentation

• Quote Procedure
• Quote Processing Flowchart
• Order Processing/Contract Review Procedure
• Order Processing/Contract Review Flowchart
• Order Change Process Flowchart
• Customer Change Notice Form
• Nonconforming Material Due to Revision Change

7.2.2 Review of requirements related to the product

The organization reviews the requirements related to the product. This review is conducted prior to the organizations commitment to supply a product to the customer (e.g. acceptance of contracts or orders, acceptance of changes to contracts or orders) and ensures that:

• product requirements are defined,
• contract or order requirements differing from those previously expressed are resolved, and
• the organization has the ability to meet the defined requirements.
• risks, such as new technology or short delivery time scale, have been evaluated.

Records of the results of the review and actions arising from the review are maintained (see 4.2.4). Where the customer provides no documented statement of requirement, the customer requirements are confirmed by the organization before acceptance. Where product requirements are changed, the organization ensures that relevant documents are amended and that relevant personnel are made aware of the changed requirements.

Supporting Documentation:

• Order Processing/Contract Review Procedure Described
• Order Processing/Contract Review Flowchart
• Order Change Process Flowchart
• Customer Change Notice Form
• Nonconforming Material Due to Revision Change

7.2.3 Customer communication

The organization determines and implements effective arrangements for communicating with customers in relation to:

• product information,
• enquiries, contracts or order handling, including amendments, and
• customer feedback, including customer complaints.

Supporting Documentation

• Order Processing/Contract Review Procedure Described
• Order Processing/Contract Review Flowchart
• Order Change Process Flowchart
• Customer Change Notice Form
• Nonconforming Material Due to Revision Change

7.3 Design and development

The organization has no design and development activities and claims exclusion from the requirements of Section 7.3, Design and Development.

7.4 Purchasing

7.4.1 Purchasing process

The organization ensures that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product is dependent upon the effect of the purchased product on subsequent product realization or the final product.

The organization is responsible the quality of all products purchased from suppliers, including customer-designated sources.

The organization evaluates and selects suppliers based on their ability to supply product in accordance with the organizations requirements. Criteria for selection, evaluation and re-evaluation are established. Records of the results of evaluations and any necessary actions arising from the evaluation is maintained (see 4.2.4).

• An Approved Supplier List is maintained and includes the scope of the approval.
• Supplier performance is periodically reviewed to establish the level of controls to be implemented.
• The procedure defines the necessary actions to take when dealing with a supplier that does not meet the requirements.
• Controls are in place to prevent the purchase of counterfeit/suspect unapproved parts.
• When applicable, ensuring that both the organization and suppliers use customer-approved special process sources.
• Ensuring that the function has responsibility for approving supplier quality systems also has the authority to disapprove the use of sources.

Supporting Documentation:

• Purchasing Flowchart, Purchasing Procedure,Purchasing Critical Materials
• Supplier Approval Process Flowchart, Supplier Selection Criteria, New Supplier Approval Form
• Supplier Corrective Action Request Form
• KTMC Approved Supplier List

7.4.2 Purchasing Information

Purchasing information describes the product to be purchased, including where applicable:

• requirements for approval of product, procedures, processes and equipment,
• requirements for qualification of personnel, and
• quality management system requirements.
• the name/product description or other positive identification, and applicable issues of specifications, drawings, process requirements, inspection instructions and other relevant technical data ,
• requirements for design, test, examination, inspection and related instructions for acceptance by the organization,
• requirements relative to supplier notification to organization of nonconforming product and arrangements for organization approval of supplier nonconforming material,
• requirements for the supplier to notify the organization of changes in product and and/or process definition and, where required, obtain organization approval,
• right of access by the organization, their customer, and regulatory authorities to all facilities involved in the order and to all applicable records, and
• requirements for the supplier to flow down to sub-tier suppliers the applicable requirements in the purchasing documents, including key characteristics where required.

The purchasing documents are reviewed to ensure the adequacy of specified purchase requirements prior to orders are placed with the supplier. supplier, and the organization maintains relevant purchasing documents and records to the extent required for traceability.

7.4.3. Verification of purchased product

The organization has established and implemented the inspection or other activities necessary to ensure that purchased product meets specified purchase requirements.

Verification activities may include;

• Obtaining objective evidence of the quality of the product from suppliers.
• Inspection and audit at supplier's premises.
• Review of required documentation.
• Inspection of product upon receipt.
• Delegation of verification to the supplier, or supplier certification.

Purchased product is not used or processed until it has been verified as conforming to specified requirements unless it is released under positive recall procedures.

When the test reports are utilized to verify purchased product, the data in the reports must be acceptable per applicable specifications. The organization periodically validates test reports for raw material.

When the organization delegates verification activities to the supplier, the requirements for delegation are defined and a register of delegations maintained.

Where the organization or its customer intends to perform verification at the supplier's premises, the organization states the intended verification arrangements and method of product release in the purchasing information.

Where specified in the contract, the customer, or the customer's representative is afforded the right to verify at the supplier's premises and the organization's premises that subcontracted product conforms to specified requirements.

the organization does not use verification performed by the customer as evidence of effective quality control by the supplier. The customer's verification also does not absolve organization of the responsibility to provide acceptable product, nor precludes subsequent rejection by the customer.

Supporting Documentation

• Receiving Flowchart
• Receiving Procedure

7.5 Production and service provision

7.5.1 Control of production and service provision

Planning considers, as applicable:

• the establishment of process controls and development of control plans where key characteristics have been identified,
• the identification of in-process verification points when adequate verification of conformance cannot be performed at a later stage of realization,
• the design, manufacturing, and use of tooling so that variable measurements can be taken, particularly for key characteristics, and
• special processes (see 7.5.2)

The organization plans and carries out production and service provisions under controlled conditions. Controlled conditions include, as applicable:

• the availability of information that describes the characteristics of the product,
• the availability of work instructions, as necessary,
• the use of suitable equipment,
• the availability and use of monitoring and measuring equipment,
• the implementation of monitoring and measurement activities, and
• the implementation of product release, delivery and post-delivery activities.
• accountability for all product during manufacture,
• evidence that all manufacturing and inspection operations have been completed as planned, or as otherwise documented and authorized,
• provision for the prevention, detection, and removal of foreign objects,
• monitoring and control of utilities and supplies such as water, compressed air, electricity and chemical products to the extent they affect product quality, and
• criteria for workmanship, which shall be stipulated in the clearest practical manner (e.g., written standards, representative samples or illustrations).

Supporting documentation

• Production Provision
• ProductionRelease
• Production Overview Flowchart

7.5.1.1 Production Documentation:

Production operations are carried out in accordance with approved data. This data contains as necessary

• drawings, parts lists, process flow charts including inspection operations, production documents (e.g. manufacturing plans, traveler, router, work order, process cards); and inspection documents (8.2.4.1), and

• a list of specific or non-specific tools and numerical control (NC) machine programs required and any specific instructions associated with their use.

7.5.1.2 Control of Production Process Changes, as applicable:

• Persons authorized to approve changes to production processes are identified (only Production Manager or Operations Manager can approve the changes).

• The organization identifies and obtains acceptance of changes that require customer and/or regulatory authority approval in accordance with contract or regulatory requirements.

• Changes affecting processes, production equipment, tools and programs is documented. Procedures are available to control their implementation.

• The results of changes to production processes are assessed to confirm that the desired effect has been achieved without adverse effects to product quality.

7.5.1.3 Control of Production Equipment, Tools and Numerical Control (NC) Machine programs, as applicable:

• Production equipment, tools and programs are validated prior to use and maintained and inspected periodically. Validation prior to production use includes verification of the first article produced to the customer print specification.

• Storage requirements, including periodic preservation/condition checks, are established for production equipment or tooling in storage.

7.5.1.4 Control of Work Transferred, on a Temporary basis, Outside the Organization's Facility, as applicable:

• When planning to temporarily transfer work to a location outside the organizations facilities, the organization defines the process to control and validate the quality of the work.

7.5.1.5 Control of Service Operations:

Where servicing is a specified requirement, service operation processes shall provide for

a) method of collecting and analizing in-service data,

b) actions to be taken where problems are identified after delivery, including investigation, reporting activities, and actions on service information consistent with contractual and/or regulatory requirements,

c) the control and updating of technical documentation,

d) the approval, control, and use of repair schemes, and

e) the controls required for off-site work (e.g., organization's work undertaken at the customer's facilities).

The company does not design any products for customer use. Some portions of these standards do not apply to the organization due to the nature of our business. These are:

• the organization has no authority or ability to establish a new design specification or change and existing design specification

• the organization does not perform off-site work

Supporting Documentation

• Rework Approval Form

7.5.2 Validation of processes for production and service provision

The organization validates any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. (Note: These processes are frequently referred to as special processes) When required, the organization utilizes the customer designated sources or Napcap facilities for special processes.

Validation demonstrates the ability of these processes to achieve planned results.

As applicable, the organization establishes arrangements for these processes including:

• defined criteria for review and approval of the processes,
• qualification and approval of special processes prior to use,
• control of the significant operations and parameters of special processes in accordance with documented process specifications and changes there to,
• approval of equipment and qualification of personnel,
• use of specific methods and procedures,
• requirements for records (see 4.2.4), and
• revalidation.

Supporting Documentation

• Purchasing Critical Materials

7.5.3 Identification and traceability:

• Where appropriate, the organization identifies the product by suitable means throughout product realization.
• The organization maintains the identification of the configuration of product in order to identify any differences between the actual configuration and agreed configuration.
• Product is identified with respect to monitoring and measurement requirements throughout product realization.
• Documented controls are in place for acceptance authority media.
• Where traceability is a requirement, the organization controls the unique identification of the product and maintain records (4.2.4).
• The organization has established and maintains a documented procedure for product identification and traceability by suitable means from receipt, during splitting, storage, packaging and preservation operations and until delivery.

According to the level of traceability required by contract, regulatory or other established requirements, the organization provides for:

• identification to be maintained throughout the product life;
• all the products manufactured from the batch of raw material 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 a given product, a sequential record of its production (manufacture, assembly, inspection) to be retrieved.

Supporting Documentation

• Shipping and Billing Flowchart

• Shipping Procedure

7.5.4 Customer property

Care is exercised with customer property while it is under the organizations control or being used by the organization. The organization identifies, verifies, protects and safeguards customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, the organization reports to the customer and mainains records (see 4.2.4).

Note: Customer property can include intellectual property and personal data.

Supporting Documentation

Customer Supplied Product Flowchart

7.5.5 Preservation of product

The organization preserves product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, preservation includes identification, handling, packaging, storage and protection. Preservation also applies to the constituent parts of a product.

Where applicable in accordance with product specifications and/or applicable regulations, preservation of product also includes provisions for

• cleaning;
• prevention, detention and removal of foreign objects;
• special handling for sensitive products;
• marking and labeling including safety warnings;
• shelf life control and stock rotation;
• special handling for hazardous materials.

the organization ensures that documents required by the contract or purchase order to accompany the product are present at delivery and are protected against loss and deterioration.

7.6 Control of Monitoring and Measuring Equipment

The organization has determined the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements.

A database is maintained of monitoring and measuring devices that defines the processes employed for their calibration including details of equipment type, unique identification, location, frequency of checks, check method and acceptance criteria.

Processes have been established to ensure that monitoring and measurement to be carried out in a manner that is consistent with monitoring and test being carried out.

The organization ensures that environmental conditions are suitable for the calibrations, inspections, measurements and test being carried out.

Where necessary to ensure valid results measuring equipment is:

• calibrated or verified, or both at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded (see 4.2.4),
• adjusted or re-adjusted as necessary,
• have identification in order to determine its calibration status.
• safeguarded from adjustments that would invalidate the measurement result, and
• protected from damage and deterioration during handling, maintenance and storage.
• recalled to a defined method when requiring calibration.

In addition, Quality Assurance assesses and records the validity of the previous measuring results when the equipment is found not to conform to requirements.

• Quality Assurance takes appropriate action on the equipment and any product affected. Records of the results of calibration and verification are maintained (see 4.2.4).
• When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application is confirmed. This is undertaken prior to initial use and reconfirmed as necessary.

Supporting Documentation

• Gauge Calibration Flowchart
• Calibration Instruction

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