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, manufacture, and use of tooling so that variable measurements can be taken, particularly for key characteristics, and

-            special processes (see 7.5.2).

 

Planning takes place during the development of the Bill of Operations.  Required operations are determined and special inspection requirements will be recorded on the Work Order.

 

MII plans and carries out production and service provision under controlled conditions. Controlled conditions include, as applicable:

a.          the availability of information that describes the characteristics of the product,

b.          the availability of work instructions, as necessary,

c.          the use of suitable equipment,

d.          the availability and use of monitoring and measuring devices,

e.          the implementation of monitoring and measurement,

f.           the implementation of release, delivery and post-delivery activities,

g.          accountability for all product during manufacture (e.g., parts quantities, split orders, nonconforming product),

h.         evidence that all manufacturing and inspection operations have been completed as planned, or as otherwise documented and authorized,

i.           provision for the prevention, detection, and removal of foreign objects,

j.           monitoring and control of utilities and supplies such as water, compressed air, electricity and chemical products to the extent they affect product quality, and

k.          criteria for workmanship, which shall be stipulated in the clearest practical manner (e.g., written standards, representative samples or illustrations).

 

See Process Control Procedure P4.9 and Inspection and Testing Procedure P4.10

 

7.5.1.1 Production Documentation

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

a.          drawings, parts lists, process flow charts including inspection operations, production documents (e.g., work orders); and inspection documents (see 8.2.4.1), and

b.         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

Persons authorized to approve changes to production processes shall be identified.

 

MII 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 shall be documented. Procedures shall be available to control their implementation (see P4.9). 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 (N.C.) Machine Programs

Production equipment, tools and programs are validated prior to use and maintained/inspected periodically according to the Inspection and Testing Procedure (P4.10).  Validation prior to production includes verification of the first article produced to the design data/specification.

 

Storage requirements, including periodic preservation/condition checks, are established for production equipment or tooling in storage. This is conducted during periodic internal audits.

 

7.5.1.4 Control of Work Transferred, on a Temporary Basis, Outside MII’ Facilities

 When planning to temporarily transfer work to a location outside MII’ facilities, MII defines the process to control and validates the quality of the work (see Purchasing 7.4).

 

7.5.1.5 Control of Service Operations

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

 

7.5.2      Validation of Processes for Production and Service Provision

MII validates any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement.  This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. Currently MII does not have any special processes.

 

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

 

MII shall establish arrangements for these processes including, as applicable:

a.          defined criteria for review and approval of the processes,

-            qualification and approval of special processes prior to use,

b.          approval of equipment and qualification of personnel,

c.          use of specific methods and procedures,

-            control of the significant operations and parameters of special processes in accordance with documented process specifications and changes thereto,

d.          requirements for records (see 4.2.4), and

e.          revalidation.

 

7.5.3      Identification and Traceability

Where appropriate, MII identifies the product by suitable means throughout product realization.

 

MII maintains the identification of the configuration of the product in order to identify any differences between the actual configuration and the agreed configuration.

 

MII identifies the product status with respect to monitoring and measurement requirements through the use of Bill of Operations (BOO’s) and Work Orders  (see Procedures P4.8 Identification and Traceablity and P4.9 Process Control).

 

When acceptance authority media are used (e.g., stamps, electronic signatures, passwords), MII shall establish and document controls for the media (see Procedure P4.8 Identification and Traceablity).

 

Where traceability is a requirement, MII shall control and record the unique identification of the product (see 4.8).

 

According to the level of traceability required by contract, regulatory, or other established requirement, MII’ Identification and Traceablity Procedure (P4.8) provides for:

a.          identification to be maintained throughout the product life;

b.         all the products manufactured from the same 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;

c.          for an assembly, the identity of its components and those of the next higher assembly to be traced;

d.          for a given product, a sequential record of its production (manufacture, assembly, inspection) to be retrieved.

 

7.5.4      Customer Property

MII exercises care with customer property while it is under MII' control or being used by MII. MII 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, it is reported to the customer and records maintained (see Control of Customer Property Procedures P4.7).

 

7.5.5      Preservation of Product

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

 

Preservation of product shall also include, where applicable in accordance with product specifications and/or applicable regulations, provisions for:

a.          cleaning (P4.9 Process Control);

b.         prevention, detection and removal of foreign objects (P4.15 Material Handling);

c.          special handling for sensitive products (P4.15 Material Handling);

d.          marking and labeling including safety warnings (P4.15 Material Handling);

e.          shelf life control and stock rotation (P4.15 Material Handling);

f.           special handling for hazardous materials (P4.15 Material Handling).

 

MII shall ensure that documents required by the contract/order to accompany the product are present at delivery and are protected against loss and deterioration (see Procedure P4.15, Handling).

 

7.6       Control of Monitoring and Measuring Devices

MII determines 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).

 

Guidance is given in the Control of Inspection, Measuring and Test Equipment (Procedure P4.11).

 

MII maintains a register of these monitoring and measuring devices, and defines the process employed for their calibration including details of equipment type, unique identification, location, frequency of checks, check method and acceptance criteria.

 

MII has established the Control of Inspection, Measuring and Test Equipment Procedure (P4.11) 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.

 

MII ensures that environmental conditions are suitable for the calibrations, inspections, measurements and tests that are being carried out.

 

Where necessary to ensure valid results, measuring equipment is:

a.          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;

b.          adjusted or re-adjusted as necessary;

c.          identified to enable the calibration status to be determined;

d.          safeguarded from adjustments that would invalidate the measurement result;

e.          protected from damage and deterioration during handling, maintenance and storage;

f.           recalled to a defined method when requiring calibration.

 

In addition, MII assesses and records the validity of the previous measuring results when the equipment is found not to conform to requirements. MII takes appropriate action on the equipment and any product affected. Records of the results of calibration and verification are maintained (see Quality Records 4.2.3).

 

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.