7.          PRODUCT REALIZATION

7.1       Planning of Product Realization

MII plans and develops the processes needed for product realization. Planning of product realization is consistent with the requirements of the other processes of the quality management system (see 4.1).

 

In planning product realization, MII determines the following, as appropriate:

a.          quality objectives and requirements for the product; (See Procedures P4.10 Inspecting and Testing)

b.          the need to establish processes, documents, and provide resources specific to the product; (See Procedures P4.3 Contract Review and P4.9 Process Control)

c.          required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance; (See Procedures P4.3 Contract Review, P4.6 Purchasing, P4.9 Process Control, and P4.10 Inspection and Testing)

d.          records needed to provide evidence that the realization processes and resulting product meet requirements (see Quality Records Procedure P4.16);

e.          the identification of resources to support operation and maintenance of the product. (See Process Control P4.9)

 

The output of this planning is in a form suitable for MII' method of operations.  The production documents needed are documented in the Processes - Contract Review P4.3, Purchasing P4.6, Process and Control P4.9, and Inspection and Testing P4.10.

 

7.2       Customer-Related Processes

7.2.1      Determination of Requirements Related to the Product

MII determines:

a.            requirements specified by the customer, including the requirements for delivery and post-delivery activities, (Procedure P4.3, Contract Review).

b.            requirements not stated by the customer but necessary for specified or intended use, where known,

- Mallory utilizes Contract Review forms, Engineering Change Notices, and Work Order Travelers to document these additional requirements.

c.          statutory and regulatory requirements related to the product, and

d.          any additional requirements determined by MII.

 

See Procedure P4.3, Contract Review.

 

7.2.2   Review of Requirements Related to the Product

MII shall review the requirements related to the product. This review shall be conducted according to Procedure P4.3 Contract Review.  MII’ 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:

a.            product requirements are defined,

b.            contract or order requirements differing from those previously expressed are resolved,

c.             MII has the ability to meet the defined requirements, and

d.            risks (e.g., new technology, short delivery time scale) have been evaluated.

(see Procedure P4.3, Contract Review).

 

Records of the results of the review and actions arising from the review are maintained (see P4.3, Contract Review Procedure).

 

Where the customer provides no documented statement of requirement, the customer requirements are confirmed by MII before acceptance.

 

Where product requirements are changed, MII ensures that relevant documents are amended and that relevant personnel are made aware of the changed requirements.

 

7.2.3      Customer Communication

MII shall determine and implement effective arrangements for communicating with customers in relation to:

a.          product information, (web, catalogues, sales visits)

b.          enquiries, contracts or order handling, including amendments, and (phone system, web, email, sales contact)

c.          customer feedback, including customer complaints (phone, mail, email, surveys, customer supplier ratings, etc) .

 

7.3          Design and Development

 

Currently MII does not perform Design and Development operations and is exempt from this requirement.