For guidance, refer to MIL-Q-9858, MIL-I-45208, and
FAR 21.303(h) (aircraft batteries). An effective quality control organization
has complete authority over the parts and materials to be used in deliverable
hardware. The Quality Control Manager never reports to the production
It is recommended that the manufacturer write a formal
quality plan. This plan describes the quality program to be used to produce
and maintain the level of quality of the product to the requirements of the
The receiving inspection function will assure the
quality of the incoming materials, assemblies, and products through
inspection, sampling, or use of vendor certificates of compliance. The
performance of vendors in supplying the proper quality level of materials in a
timely manner will be assessed.
The basic philosophy of any quality control effort is
prevention. In the manufacture of a product, quality begins with the
purchasing of the raw materials. The vendor is considered an extension of the
production operation. The vendor must:
understand the requirements
have the resources to meet these
have a quality philosophy of prevention
have a statistical monitoring process such that
the products sent can be certified to meet the requirements.
Incoming raw material checks are a monitoring function
to assure that raw materials meet the specified requirements.
The receiving inspection function will have access to
test and measuring equipment which will permit proper inspection and
measurement to drawing or specification requirements. Test and measuring
equipment typically include:
Dimensional equipment for measuring component
parts to a proper accuracy to meet drawing requirements
Measuring equipment used for monitoring the purity
of active chemical ingredients
Testing equipment for measuring required physical
parameters such as shock and vibration, strength of components and other
important physical parameters required by the procurement
After raw material quality assurance, production can
begin. Depending on the process, various check points are established to:
assure process capabilities
maintain process within control limits
provide the basis for early warning of process
At no time should sorting be relied upon to provide a
quality product. As a general rule-of-thumb, it is recommended that process
capabilities exceed the specification tolerance by a factor of two to control
product variability to acceptable levels.
The manufacturing processes will be maintained in such
a way as to assure that quality components and products are being produced in
a consistent manner. The use of quality control techniques employing sampling
plans and statistical process control systems shall be used whenever possible.
These techniques may include the use of Process Control Charts such as trend
charts for maintaining the process within control limits. Average and Range
charts are used to assure that the process is being maintained or controlled
in a consistent manner. Other in-process inspections shall be used to assure
the quality of the components, materials, and subassemblies as they are being
used and produced.
Configuration Control System
When the design of the product has been qualified and
approved, it is maintained through a configuration control system. All
drawings, specifications, and processes which may affect the qualified design
will be controlled so unauthorized changes cannot be made.
Any changes to the configuration, including drawings,
specifications, and processes will be done through the Engineering Change
Order (ECO) process. The nature of the change will be assessed by qualified
personnel. They must assure that the change will not negatively affect
performance, form, fit, or function of the component or part. Approval of the
ECO by DCAS or other government authority is required before implementation of
Changes of components, change of plant location, plant
shut-down, expiration of time limit, or product not manufactured during time
limit may require additional qualification testing to assure and document that
the change will not affect the performance of the cells or batteries. All
changes to critical components will be documented and listed for review by
Government technical personnel. The change will appear on drawings or
specifications as a new revision level.
When components, subassemblies, or products are
determined to be non- conforming (i.e., they do not meet drawing, process, or
specification requirements), they will be identified, segregated, and reviewed
by appropriate personnel. The cause for the non-conformance will be determined
and appropriate action taken to prevent future problems.
A formal procedure will be used for making final
disposition of non-conforming materials. Upon appropriate review (usually by a
Material Review Board) a disposition will be made which may include:
Use as is since the non-conformance will not
affect the form, fit, or performance of the product
Rework to bring into conformance
Return to vendor.
Internal Quality Auditing
Where possible, the manufacturer will have personnel
assigned to periodically audit manufacturing and quality functions to assure
that the quality system is being maintained. It will be the function of the
auditor to determine that appropriate drawings, specifications, and processes
are in use and that documentation of inspections, measurements, and tests is
being done in an appropriate manner.
The auditor will determine that appropriate revision
levels of all drawings and specifications are in place and that manufacturing
personnel are operating according to their provisions.
Deficiencies which are detected by the auditor will be
documented and corrective actions will be made by the appropriate supervisory
personnel. The quality auditor will maintain a system of performance
measurements such as a "compliance index." This index can be used by
management to determine whether the manufacturing system is being maintained
properly or corrective actions are required.
Control Of Measuring And Test Equipment
A system will be maintained or be accessible to the
manufacturer for calibrating and assuring the accuracy of all measuring and
testing equipment which is used for producing, controlling, or inspecting
components and products. The equipment will be included in a formal program
for periodic evaluation and calibration. All measurement accuracies will be
assured through traceability to a recognized national standard such as the
National Institute of Standards and Technology.
Rework that brings the product to full conformance may
be allowed. When the finished product is reworked, a written rework procedure
should be prepared and approved by the customer and the reworked product
should be re-inspected. The customer is defined by the contract and may be
either the procuring activity or the Government. Repair that makes a product
usable but not to full conformance may not be allowed, unless approved by the
The manufacturer can be allowed Material Review Board
authority (defined and agreed to in advance) for any nonconformance that does
not affect form, fit, or function of the finished product. In these instances,
the Government should be notified of the nonconformance. If the nonconformance
affects the form, fit or function, the Government should be part of the
Material Review Board.