Quality Manual

7. Product realization

June 6, 2006; Issue 1

7.1 Planning of product realization
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
7.2.2 Review of requirements related to the product
7.2.3 Customer communication
7.3 Design and Development (not included in scope of this manual)
7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.2 Validation of processes for production and service provision
7.5.3 Identification and traceability
7.5.4 Customer property
7.5.5 Preservation of product
7.6 Control of monitoring and measuring device

7.1 Planning of product realization

The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).

In planning product realization, the organization shall determine the following, as appropriate:

1. quality objectives and requirements for the product;
2. the need to establish processes, documents, and provide resources specific to the product;
3. required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;
4. records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4.).

The output of this planning shall be in a form suitable for the organization's method of operations.

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, can be referred to as a quality plan.

NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes.

7.1 Planning of product realization

The Quality Manager has the responsibility for ensuring that adequate activities are planned to assure product quality.

The company prepares a job/part file, from which a shop order is generated, which details quality requirements for the product.

The part file details processing requirements and the company has prepared work instructions detailing inspection requirements and records required.

7.2 Customer-related processes

7.2.1 Determination of requirements related to the product

The organization shall determine

1. requirements specified by the customer, including the requirements for delivery and post-delivery activities,
2. requirements not stated by the customer but necessary for specified or intended use, where known,
3. statutory and regulatory requirements related to the product, and
4. any additional requirements determined by the organization.

7.2 Customer-related processes

7.2.1 Determination of requirements related to the product

The Sales Department is responsible to assure customer and associated requirements are determined (QSP-0710).

7.2.2 Review of requirements related to the product

The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that

1. product requirements are defined,
2. contract or order requirements differing from those previously expressed are resolved, and
3. the organization has the ability to meet the defined requirements.

Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4.).

Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.

Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.

NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.

7.2.2 Review of requirements related to the products

The Sales Department is responsible for review of initial and changed customer orders. Procedure QSP-0710 outlines these requirements.

7.2.3 Customer communication

The organization shall determine and implement effective arrangements for communicating with customers in relation to

1. product information,
2. enquiries, contracts or order handling, including amendments, and
3. customer feedback, including customer complaints.

7.2.3 Customer communication

The company assures adequate communication and feedback with customers on product information and inquiries and orders

7.3 Design and development

7.3.1 Design and development planning

The organization shall plan and control the design and development of product.

During the design and development planning, the organization shall determine

1. the design and development stages,
2. the review, verification and validation that are appropriate to each design and development stage, and
3. the responsibilities and authorities for design and development.

The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.

Planning output shall be updated, as appropriate, as the design and development progresses.

7.3 Design and development

CLAUSE EXCLUSION
Design and development is not included in the scope of the Quality System, as the customer is responsible for product design in terms of finish machined dimensions, material grade and heat treatment condition.

Consequently this Quality Manual contains no procedures and policies related to this clause.

7.3.2 Design and development inputs

Inputs relating to product requirements shall be determined and records maintained (see 4.2.4.). These inputs shall include

1. functional and performance requirements,
2. applicable statutory and regulatory requirements,
3. where applicable, information derived from previous similar designs, and
4. other requirements essential for design and development.

These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other.

Not applicable

7.3.3 Design and development outputs

The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.

Design and development outputs shall

1. meet the input requirements for design and development,
2. provided appropriate information for purchasing, production and for service provision,
3. contain or reference product acceptance criteria, and
4. specify the characteristics of the product that are essential for its safe and proper use.

Not applicable

7.3.4 Design and development review

At suitable stages, systematic review of design and development shall be performed in accordance with planned arrangements (see 7.3.1)

1. to evaluate the ability of the results of design and development to meet requirements, and
2. to identify any problems and propose necessary actions.

Participants in such reviews shall include representatives of functions concerned with the design and development stages(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4).

Not applicable

7.3.5 Design and development verification

Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4).

Not applicable

7.3.6 Design and development validation

Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (see 4.2.4).

Not applicable

7.3.7 Control of design and development changes

Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.

Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4).

Not applicable

7.4 Purchasing

7.4.1 Purchasing process

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

The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluation and any necessary actions arising from the evaluation shall be maintained (see 4.2.4).

7.4 Purchasing

7.4.1 Purchasing process

The company has issued procedures and routines for the purchase of product and services determined to affect product quality (QSP-0740)

7.4.2 Purchasing information

Purchasing information shall describe the product to be purchased, including where appropriate

1. requirements for approval of product, procedures, processes and equipment,
2. requirements for qualification of personnel, and
3. quality management system requirements.

The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.

7.4.2 Purchasing information

Purchase orders clearly describe product requirements. See QSP-0740

7.4.3 Verification of purchased product

The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.

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

7.4.3 Verification of purchased product

The company has issued procedures and instructions detailing controls for purchased product requiring receiving inspection, including type of product, inspection technique, and level (QSP-0824).

The company reserves the right to verify purchased product at the suppliers' premises or upon receipt of product from the supplier.

7.5 Production and service provision

7.5.1 Control of production and service provision

The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable

1. the availability of information that describes the characteristics of the product,
2. the availability of work instructions, as necessary,
3. the use of suitable equipment,
4. the availability and use of monitoring and measuring devices,
5. the implementation of monitoring and measurement, and
6. the implementation of release, delivery and post-delivery activities.

7.5 Production and service provision

7.5.1 Control of production and service provision

The company has issued procedures and routines to control processes that affect quality (QSP-0751)

The company prepares a (shop order/router/work order) that details the characteristics of the product and details the designated equipment to manufacture the product.

The company has issued procedures and routines for the inspection and testing of the product (QSP-0824)

7.5.2 Validation of processes for production and service provision

The organization shall validate any processes for production and service provision where subsequent monitoring or measurement cannot verify the resulting output. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.

Validation shall demonstrate the ability of these processes to achieve planned results.

The organization shall establish arrangements for these processes including, as applicable

1. defined criteria for review and approval of the processes,
2. approval of equipment and qualification of personnel,
3. use of specific methods and procedures,
4. requirements for records (see 4.2.4), and
5. revalidation.

7.5.2 Validation of processes for production and service provision

The company has no special processes and has excluded this clause from its QMS. Should there be a need for special processes in the future, CPM will create validation processes at that time.

7.5.3 Identification and traceability

Where appropriate, the organization shall identify the product by suitable means throughout product realization.

The organization shall identify the product status with respect to monitoring and measurement requirements.

Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4).

NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained.

7.5.3 Identification and traceability

As appropriate, the company identifies products to ensure that the individual orders are kept separate (QSP-0753)

The company operates using a system that identifies inspection and test status based on location of product, identification of product and documented evidence that product has completed inspection, meeting all acceptance criteria.

Unique identification for traceability purposes is maintained, when required by customers.

7.5.4 Customer property

The organization shall exercise care with customer property while it is under the organization's control or being used by the organization. The organization shall identify, verify, protect and safeguard 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, this shall be reported to the customer and records maintained (see 4.2.4).

NOTE Customer property can include intellectual property.

7.5.4 Customer property

The company has issued procedures and routines to control and handle products and property supplied by the customer intended for incorporation in the delivery (QSP-0754).

The company notifies the customer of any material, product or property lost, damaged, or scrapped.

7.5.5 Preservation of product

The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.

7.5.5 Preservation of product

The company has issued procedures detailing the routines and practices necessary to ensure the safe handling, identification, storage, packaging, preservation and delivery of product. (QSP-0755)

7.6 Control of monitoring and measuring devices

The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1).

The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.

Where necessary to ensure valid results, measuring equipment shall

1. be calibrated or verified 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;
2. be adjusted or re-adjusted as necessary;
3. be identified to enable the calibration status to be determined;
4. be safeguarded from adjustments that would invalidate the measurement result;
5. be protected from damage and deterioration during handling, maintenance and storage.

In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements.  The organization shall take appropriate action on the equipment and any product affected.  Records of the results of calibration and verification shall be 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 shall be confirmed.  This shall be undertaken prior to initial use and reconfirmed as necessary.

NOTE  See ISO 10012-1 and ISO 10012-2 for guidance.

7.6 Control of monitoring and measuring devices

The company has issued procedures and instructions to ensure the accuracy of measurement results are maintained, and equipment calibrated (QSP-0760)

• Measuring and test equipment is maintained traceable to a national standard or other accepted industrial standard.
• Measuring and test equipment is uniquely identified.

The calibration procedure (QSP-0760) and calibration system addresses all the requirements of.