CHAPTER 5 QUALITY

PURPOSE AND SCOPE MANUFACTURING CONTROL

The complex issues surrounding the development, manufac- New Products Quality Planning
ture/processing, or service of any product for today’s market
require an effective quality system to identify, document, coordi- A team approach should be used in developing a Quality Plan
nate and control all key activities necessary to support that service in advance of new product manufacturing. This plan is based on
or product. Quality starts with marketing, progresses to product the selection of key characteristics governed by: fit, function, form
design, to materials’ suppliers, to the manufacturing process, and (appearance), processing and assembly. Purchasing, Sales,
to distribution. It encompasses the entire organization from top Quality, Engineering, Manufacturing, and other affected functions
management to the workforce. Continuous improvement should should meet, discuss and finalize items such as:
be an organizational philosophy supported by top management z Process Capabilities
and understood and carried out by all personnel in a company. In z Tolerances
order to meet customer expectations at economical product costs, z Control Plans (Inspection Points)
quality cannot be “inspected in”. Quality encompasses the overall z Gaging
system and must be designed into the process. z SPC Requirements - Key Characteristics
The intent of this chapter is to define the elements that are nec- z Capacities
essary for a total quality program for manufacturing molded, z Personnel Needed
extruded, lathe cut, sponge and expanded rubber products. z Equipment Needed
Manufacturers should choose those portions of the total quality Drawing and Specification Control
program that are applicable to their business requirements.
A documented system must be maintained to assure that all
QUALITY SYSTEM CONTROL PROCEDURES drawings and specifications are complete and current. The system
Quality efforts should begin at the very inception of a product, must address the control of revisions and deviations and the dis-
using customer input as a guide. Optimization during product and position of obsolete drawings and specifications. Written proce-
process design stages can significantly reduce manufacturing vari- dures are necessary to provide for the receipt, review, distribution
ations. Techniques such as Quality Function Deployment (QFD), and revision of drawings and specifications.
Design of Experiments, and Failure Mode Effect Analysis Purchase Order Information
(FMEA) should be studied and used as necessary in the designing
stage of a product. A system for controlling purchase orders should be established.
Before the purchase order is released, the buyer should make sure
The ISO 9000 series of quality standards should be taken into
that all requirements such as applicable drawings, specifications,
consideration when developing an overall quality management
certifications, and source inspection instructions are with the pur-
plan. chase order. A drawing or specification change after the order is
SUPPLIER RESPONSIBILITIES placed requires a purchase order change, including the latest appli-
cable drawings and/or specifications.
Suppliers of materials and services significantly influence
every product produced. Rubber manufacturers should have sys-
tems that assure effective selection, monitoring and development
of suppliers.
These should include:
z Evidence of supplier capability to meet key requirements.
z Supplier system surveys.
z Ongoing supplier performance ratings and improvement
plans based on quality, delivery and service.
Rubber manufacturers and suppliers should have a joint strate-
gy to develop a long-term cooperative relationship.

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Received Material Audit Final Audit
An effective system for assuring the quality of incoming prod- Prior to shipment to the customer, statistical samples of each
ucts and services should be maintained. Incoming materials submitted lot of material should be taken to ensure that the mate-
should meet physical, chemical, visual, functional, and dimen- rial meets the physical, visual, functional, chemical and dimen-
sional requirements. sional requirements. Written instructions should be provided to
assure that these requirements are met.
The degree and extent of the received material audit is based
upon the proprietary nature of the purchased material and the sup- Nonconforming material should be identified and segregated
plier’s quality history. Certificates of test results of key character- from the normal flow of final product. Conforming material
istics should be furnished by suppliers. should be identified and released. A periodic audit of product
ready for shipment should be performed.
Received materials are audited to assure conformance to draw-
ings or specifications and to provide process information to the Documentation of audits should be retained for a minimum of
manufacturing areas. Accepted materials should be specifically two years.
identified as such.
Nonconforming Material Control
All nonconforming material should be identified and segregat-
ed from the normal flow of accepted materials. A discrepancy A system to control nonconforming material must be estab-
report, formatted to require a corrective action response by the lished. The system must identify, segregate and provide for dispo-
supplier, should be issued for all nonconforming materials. The sition of the material. Written instructions should be provided for
corrective action document is key to prevent problem recurrence. repair or rework of the material. Corrected material must be
appropriately audited. All other nonconforming material should be
Adequate records documenting verifications and audits must discarded. In the event that nonconforming material is suspected
be maintained. Such records shall be retained for a minimum of or determined to have been shipped, the customer must be noti-
two years. fied.
Process Control Packaging and Shipping
Control procedures must be an integral part of the manufactur- The supplier is responsible for controlling packaging and ship-
ing process. The manufacturer must systematically apply proce- ping to ensure customer acceptance. Products should be handled,
dures and controls effectively to maintain required specifications, packaged and stored for their protection. Customer specifications
reduce variation, document inspection, test results, and corrective should be reviewed for special requirements concerning marking,
action. Identification of materials throughout the manufacturing packaging, packing and preservation.
process must be maintained.
Measurement Control
The manufacturer, through knowledge of the production
process and end use of the product, shall identify key characteris- A system for the calibration of test instruments, tools and gages
tics and maintain their control. Effective statistical process control used to control processes or evaluate material conformance should
(SPC) of designated control characteristics is recommended to be established. Military specification MIL-STD-45662 provides
identify variations due to the process. Appropriate responses to information on the standards of a calibration program. When jigs
variations will provide for its reduction and continual improve- or fixtures are used as measurement devices, their accuracy shall
ments. be verified at established intervals and identified to the latest
applicable engineering change.
A capability analysis should be conducted for each control
characteristic to determine whether the process is capable of satis- A program to determine measurement device capability used to
fying design intent and to verify that the machinery, operation and evaluate key characteristics should be established and maintained.
process outputs fall within specified design limits. This analysis Methods to assure the accuracy of results and use of appropriate
should be performed after production conditions are stabilized and statistical techniques to assure repeatability, reproducibility and
normal for operations. It should be conducted over an extended stability must be included in the program. Gage capability records
period of time. Process capability should be reestablished follow- shall be retained with the gage calibration documentation.
ing any process change due to product, material, tooling or envi-
Corrective Action
ronment.
When processes are identified as being unstable, incapable or Corrective action should be taken when a nonconforming prod-
out of control, immediate corrective action should be taken based uct or process is discovered internally or discovered by a cus-
on the analysis of statistical evidence. When control of the process tomer. The steps to corrective action should be: (1) definition of
has been established, continuous monitoring techniques should be the problem; (2) diagnosis of the root cause; (3) development and
employed to assure process stability. application of a remedy; and (4) evaluation of the effectiveness of
the remedy. A disciplined problem-solving approach should be
Process documentation should be retained for a minimum of used. After corrective action has been implemented, changes
two years. should be incorporated into process specifications and procedures.

59 RMA MO-1 (2005)

Documentation of corrective action is important to promote prod-
uct and process improvement.
Upon detection of the problem, effected materials should be
quarantined and evaluated. Until implementation of corrective
action, all materials should be inspected to assure conformance to
customer requirements.

Internal Quality Audit

An audit program must be established to review all systems of
a facility to assure compliance with controls and procedures.
Internal audits should be conducted periodically by personnel
independent of the element being surveyed. The procedures for an
audit must be written, and formal reports of the results issued.
Provisions should be made for correction of any deficiencies.
SERVICE
After the successful design, manufacture and delivery of a
product, it is necessary to measure customer satisfaction. This can
be achieved by gathering and analyzing information on a routine
basis and should include:
z Dealing with customer complaints in a timely, courteous
manner with prompt disposition and replacement of unac-
ceptable products.
z Routine visits to the customer, other than response to com-
plaints, in order to determine how the product could be
improved. This information should be given to the appropri-
ate staff functions who would work with the customer to
improve the product.
z Obtaining field performance information from the customer,
outside organizations, or internally in order to define ways
to improve the product.
In cases where the customer requests certification data for
incoming products, an agreement should be reached as to the type
and frequency of such data before production begins:
z For product characterization of a given lot, routine test
results could accompany each lot.
z When quality data is requested, it is recommended that such
data be available on a quarterly basis.
PEOPLE
The quality philosophy considers that the ultimate creators of
quality products and services are people. This requires that any
individual, department or team have the necessary tools, equip-
ment, expertise, support and training to produce quality work.
People must be recognized as the strength, reputation and vitality
of a company. There must be the freedom and opportunity for
employees at all levels to suggest and participate in improvement
programs. The commitment to the quality program is achieved by
an ongoing educational process, providing opportunities for use of
cognitive and intellectual skills for all employees.

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