Original Issue:
Quality
Policy
|
Molded
Rubber & Plastic Corporation will continually strive to be a
recognized |
This Quality Manual
establishes Molded Rubber & Plastic Corp. (MRPC) commitment to comply with
those standards and regulations listed in the standards and regulations section
of this Quality Manual. This Quality Manual applies to production, sales and
marketing activities conducted by MRPC.
Scope:
The custom molding of standard rubber, thermoplastic rubber, and thermoplastic components, and the custom extrusion of rubber products. This scope shall exclude design.
Exclusions
are as follows;
Design &
Development: MRPC
does not design or develop products on a Proprietary
basis. Design and development will be the responsibility of the customer
and
/ or vendor.
MRPC’s QMS satisfies the
full range of requirements of ISO9001: 2000.
| 1.3.1 | ISO9001: 2000, Quality management system – Requirements |
| 1.3.2 | ISO9001:1994, Quality systems – Model for quality assurance in design,
development, production, installation and servicing. |
| 1.3.3 | ISO9000: 2000, Quality
management systems – Fundamentals and vocabulary. |
| 1.3.4 | ISO9004: 2000,Quality management systems – Guidelines for performance improvements. |
| 1.3.5 | ISO10011-1, -2, -3, Guidelines for auditing quality systems |
| 1.3.6 | DOP.AD.001 Appendix E – Listing of external reference documents |
Molded Rubber & Plastic
Corporation is located at:
P.O. Box
246
13161
Butler
,
Phone:
(262) 781-7122
Fax:
(262) 781-5353
Web
site: www.mrpcorp.com
QMS:
Quality Management System
MRPC:
Molded Rubber & Plastic Corporation
MRPC establishes, documents,
implements, and maintains a QMS in accordance with the requirements of all
applicable standards and regulations per DOP.AD.001.
MRPC continually improves the effectiveness of its
QMS. MRPC’s QMS:
| a) | identifies the processes (including unique processes) needed for its
operations and their application throughout the organization, |
| b) | determines the sequence and interaction of these primary processes |
| c) | determines criteria and methods needed to ensure that both the
operation and management of these processes are effective, |
| d) | ensures the availability of resources and information necessary to
support the operation and monitoring of these processes, |
| e) | ensures monitoring, measurement and analyses of these processes,
and |
| f) | ensures implementation of actions necessary to achieve planned results and continual improvement of these processes. |
MRPC manages these processes
in accordance with the requirements of all applicable standards.
MRPC ensures management of
outsourced processes where any process that affects product conformity with
requirements. Methods of management of such outsourced processes are identified
within the QMS per DOP.PU.001
MRPC’s QMS documentation
includes:
| a) | documented statements of DOP.AD.002
and quality objectives, |
| b) | this Quality Manual, |
| c) | documented procedures required by all applicable standards, |
| d) | documents needed by the organization to ensure the effective
planning, operation and management of its processes, and |
| e) | quality records required by all applicable standards. |
The extent of the MRPC’s
QMS is based on:
| a) | the size of the
organization and type of activities, |
| b) | the complexity of
processes and their interactions, and |
| c) | the competence of
personnel. |
MRPC maintains its documents
on various media such as paper, electronic, etc.
MRPC establishes and
maintains a Quality Manual that includes:
| a) | the scope of the
QMS, including details of and justification for any
exclusions per the Application section of the Quality Manual, |
| b) | reference to the documented procedures established for the
QMS, and |
| c) | a description of the interaction between the processes of the
QMS. |
Documents required by the QMS
are managed per DOP.AD.003. Quality
records are a special type of document and are also managed per DOP.QA.008.
DOP.AD.003
& WI.EN.001 are established to define the means needed to:
| a) | approve documents for
adequacy prior to issue, |
| b) | review and update as
necessary and re-approve documents, |
| c) | ensure that changes and the current revision status of documents are
identified, |
| d) | ensure that relevant versions of applicable documents are available at
points of use, |
| e) | ensure that documents remain legible and readily identifiable, |
| f) | ensure that documents of external origin are identified and their
distribution managed, and |
| g) | prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. |
Quality records are
established and maintained to provide evidence of conformity to requirements and
of the effective operation of the QMS. Mechanisms are established for quality
records to remain legible, readily identifiable and retrievable. The documented
procedure DOP.QA.008 is established to
define the means needed for the identification, storage, protection, retrieval,
retention time and disposition of quality records.
MRPC’s
| a) | communicating to the organization the importance of meeting
customer as well as statutory and regulatory requirements, |
| b) | establishing the Quality
Policy, |
| c) | ensuring that quality objectives are established, |
| d) | conducting management reviews, and |
| e) | ensuring the availability of resources. |
MRPC’s
5.3 Quality policy
MRPC’s
| a) | appropriate to the purpose
of MRPC’s activities, |
| b) | a commitment to comply with requirements of all
applicable standards and regulations and continually improve the effectiveness
of the QMS, |
| c) | a framework for
establishing and reviewing quality objectives per DOP.AD.001, |
| d) | communicated and understood within the
organization per DOP.HR.001,
and |
| e) | reviewed for continuing
suitability per DOP.AD.001. |
Quality
Policy:
|
Molded
Rubber & Plastic Corporation will continually strive to be a recognized |
MRPC’s
MRPC’s
| a) | the planning of the
QMS is carried out in order to meet the requirements given
in section 4.1 of this Quality
Manual, as well as the quality objectives, and |
| b) | the integrity of the QMS is maintained when changes to the QMS are
planned and implemented. |
MRPC’s
MRPC’s
| a) | ensuring that processes needed for the QMS are established, implemented
and maintained, |
| b) | reporting to the Management Team on the performance of the QMS and any
need for improvement per DOP.AD.001, and |
| c) | ensuring the promotion of awareness of customer requirements throughout
the organization. |
Responsibilities of the
Management Representative also include liaison with external parties on matters
relating to the QMS.
MRPC’s
MRPC’s
Records of management reviews are maintained per the DOP.QA.008.
The input to management
review includes information on:
| a) | results of audits, |
| b) | customer feedback, |
| c) | process performance and product conformity, |
| d) | status of preventive and corrective actions, |
| e) | follow-up actions from previous management reviews, |
| f) | planned changes that could affect the
QMS, and |
| g) | recommendations for improvement. |
The output from the
management review includes any decisions and actions related to the following
per DOP.AD.001 :
| a) | improvement of product and processes related to internal and
external customer requirements, as determined by the review performed by CIP
teams and |
| b) | resource needs. |
MRPC’s Management Team
determines and provides the resources per DOP.AD.001
& WI.EN.001 to:
| a) | implement and maintain the QMS and continually improve its
effectiveness, and |
| b) | enhance customer satisfaction by meeting customer requirements. |
MRPC will ensure that
personnel performing work that affects quality of product are competent on the
basis of appropriate education, training, skills and experience. MRPC will
encourage the involvement and development of its employees:
| By providing ongoing training |
| By facilitating open, two way communication |
| By continually reviewing the needs of its employees, and |
| By gauging employee satisfaction |
Per DOP.HR.001
Molded Rubber & Plastic:
| a) | determines the necessary competence of
personnel performing work affecting product quality, |
| b) | provides training or takes other actions to
satisfy these needs per DOP.HR.001, |
| c) | evaluates the effectiveness of the actions taken per
DOP.HR.001, |
| d) | ensures that its personnel are aware of the relevance and importance of
their activities and how they contribute to the achievement
of the quality objectives per DOP.HR.001,
|
| e) | maintains appropriate records of education, training, skills and
experience per DOP.HR.001
and DOP.QA.008. |
Molded Rubber & Plastic
determines, provides and maintains the infrastructure needed to achieve
conformity to product requirements. Infrastructure includes, for example:
| a) | buildings, workspace and associated utilities, |
| b) | process equipment, both hardware and software, |
Planning of product
realization is consistent with the requirements of MRPC’s
QMS.
In planning product
realization, MRPC determines the following, as appropriate the:
| a) | quality objectives and requirements for the product per
WI.EN.001 |
| b) | required monitoring, inspection and test activities specific to
the product and the criteria for product acceptance per DOP.QA.002,
and |
| c) | records needed to provide evidence that the realization processes
and resulting product fulfill requirements per DOP.QA.008. |
The output of this planning
is documented per WI.EN.003.
Note:
1. A document specifying the processes of the
QMS, including the product
realization processes, and the resources applied to a specific product, project
or contract, may be referred to as a quality plan.
MRPC determines:
| a) | requirements specified by the customer,
including the requirements for delivery and post-delivery activities per
DOP.SA.001, |
| b) | requirements not stated by the customer but
necessary for specified use or known and intended use, |
| c) | statutory and regulatory requirements related to the product per DOP.SA.001, and |
| d) | any additional requirements determined by the organization. |
7.2.2 Review of requirements related to the product
MRPC reviews the requirements
related to the product per DOP.SA.001.
This review is conducted prior to MRPC’s commitment to supply a product to the
customer. It relates to such activities as submission of tenders, acceptance of
contracts or orders and acceptance of changes to contracts or orders. This
review ensures that:
| a) | product requirements are defined per
DOP.SA.001, |
| b) | contract or order requirements differing from those previously expressed
are resolved and documented, and |
| c) | MRPC has the ability to meet the defined requirements. |
Records of the results of the
review and actions arising from the review are maintained per DOP.SA.001
and DOP.QA.008.
Where the customer provides
no documented statement of requirements, the customer requirements are confirmed
before acceptance. MRPC maintains records of discussion of such requirements per
DOP.SA.001.
Where product requirements
are changed, MRPC ensures that the relevant documents are amended and that
relevant personnel are made aware of the changed requirements per DOP.SA.001
.
MRPC has determined and
implemented effective arrangements for communicating with customers in relation
to:
| a) | product information per
DOP.SA.001, |
| b) | inquiries, contracts or order handling, including amendments per
DOP.SA.001, and |
| c) | customer feedback, including customer complaints. |
MRPC does
not design or develop products on a proprietary basis. Design and development
will be the responsibility of
MRPC ensures that purchased
product conforms to specified purchase requirements per
DOP.QA.002. The type and extent of control applied to the supplier
and the purchased product depends on the effect of the purchased product on
subsequent product realization or the final product.
Purchasing information
describes the product to be purchased per DOP.PU.001.
It includes, where appropriate:
| a) | requirements for approval of product, procedures, processes and equipment |
| b) | requirements for qualification of personnel |
| c) | QMS requirements. |
MRPC ensures the adequacy of
specified purchase requirements prior to their communication to the supplier per
DOP.PU.001.
MRPC has established and
implemented the inspection or other activities necessary for ensuring that
purchased product meets specified purchase requirements per DOP.QA.002.
Where MRPC or its customer
intends to perform verification at the supplier's premises, MRPC states the
intended verification arrangements and method of product release in the
purchasing information per DOP.PU.001.
MRPC plans and carries out
production under controlled conditions. Controlled conditions include, as
applicable:
| a) | availability of information that describes the characteristics of the
product |
| b) | availability of work instructions |
| c) | use of suitable equipment |
| d) | availability and use of monitoring and measurement |
| e) | implementation of monitoring and measurement |
| f) | implementation
of release and delivery. |
MRPC validates any processes
for production 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, per WI.EN.001
and DOP.QA.008 .
Validation demonstrates the
ability of these processes to achieve planned results.
| a) | defined criteria for review and approval of the processes |
| b) | approval of equipment and qualification of personnel |
| c) | use of specific methods and procedures |
| d) | requirements for records |
| e) | re-validation |
MRPC, where appropriate,
identifies the product by suitable means throughout product realization per DOP.PP.003 & DOP.RP.002.
MRPC identifies the product
status with respect to monitoring and measurement requirements.
Where traceability is a
requirement, MRPC establishes means and records the unique identification of the
product per DOP.PP.003 & DOP.RP.002 .
Records
are maintained per DOP.QA.008.
MRPC exercises care with
customer property where it is under the organization's control and use. MRPC
identifies, verifies, protects and safeguards customer property provided for use
or incorporation into the product in the same manner as standard product. If any
customer property is lost, damaged or otherwise found to be unsuitable for use,
it is reported to the customer. Records of such reports are maintained per DOP.QA.002.
Note: Customer property can
include intellectual property.
MRPC preserves the conformity
of product during internal processing and delivery to the intended destination
per DOP.RC.001. This preservation
includes identification, handling, packaging, storage, delivery and protection.
Preservation also applies to the constituent parts of a product.
MRPC 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 per DOP.QA.001.
MRPC has established
processes to ensure that monitoring and measurement can be carried out in a
manner that is consistent with the monitoring and measurement requirements.
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 is 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 |
MRPC assesses and records the
validity of the previous measuring results when the equipment is found not to
conform to requirements per DOP.QA.003.
MRPC takes appropriate action on the equipment and any product affected.
Records of the results of calibration and verification are maintained per DOP.QA.008.
MRPC plans and implements the
monitoring, measurement, analysis and improvement processes to.
| a) | demonstrate conformity of the product |
| b) | ensure conformity of the QMS |
| c) | continually improve the effectiveness of the QMS |
This includes determination
of applicable methods, including statistical techniques, and the extent of their
use.
MRPC has defined within our system a method of analyzing and determining customer (internal / external) needs, expectations, and satisfaction and uses this information to understand and improve the performance of our quality system and manage customer satisfaction per DOP.SA.002
MRPC has established and
maintains DOP.QA.007 to
conduct internal audits at planned intervals to determine whether the
QMS:
| a) | conforms to the arrangements for planning of product realization to the requirements of all applicable standards and regulations and the QMS requirements |
| b) | is effectively implemented and maintained |
MRPC plans the audit program
taking into consideration the status and importance of the activities and areas
to be audited as well as the results of previous audits. The audit criteria,
scope, frequency and methods are defined. Selection of auditors and conduct of
audits ensures objectivity and impartiality of the audit process. Auditors do
not audit areas of their own responsibilities.
The responsibilities and
requirements for planning and conducting audits and for reporting results and
maintaining records are defined in DOP.QA.007.
The management responsible
for the area audited ensures that actions are being taken to eliminate
non-conformities and their causes. Follow-up activities include the verification
of the actions taken and the reporting of verification results per DOP.QA.007
& DOP.QA.005.
8.2.3
Monitoring and measurement of processes
MRPC applies suitable methods
for monitoring and, where applicable, measurement of the QMS processes. These
methods demonstrate the ability of the processes to achieve planned results.
When planned results are not achieved, corrective action is taken, as
appropriate, to ensure conformity of the product to established requirements.
MRPC monitors and measures
the characteristics of the product to verify that product requirements are
fulfilled. This is carried out at appropriate stages of the product realization
process in accordance with the planned arrangements per
DOP.QA.002.
Evidence of conformity with
the acceptance criteria is maintained per DOP.QA.008.
Records indicate the person(s) authorizing release of product.
Product release does not proceed until all the planned arrangements have been satisfactorily completed per DOP.QA.002, unless otherwise approved by a relevant authority.
MRPC has established and
maintains a documented Procedure
DOP.QA.003 to ensure that
product that does not conform to product requirements is identified and managed
to prevent unintended use or delivery. This process identifies related
responsibilities and authorities for dealing with non-conforming product.
MRPC
processes non-conforming product by one or more of the following ways:
| a) | taking action to eliminate the detected non-conformity |
| b) | authorizing its use, release or acceptance under concession by a relevant
authority and, where applicable, by the customer |
Records of non-conformities
and any subsequent actions taken, including concessions obtained, are maintained
per DOP.QA.008.
When non-conforming product
is corrected, it is subject to re-verification to demonstrate conformity to the
requirements per DOP.QA.002.
When non-conforming product
is detected after delivery, MRPC takes appropriate steps to correct the
non-conformity per DOP.QA.004
MRPC has established a method to collect and analyze appropriate data to determine the suitability and effectiveness of the quality system and to identify improvements that can be made. This includes data generated by measuring and monitoring activities and other relevant sources.
MRPC analyzes this data to
provide information on:
| a) | customer satisfaction |
| b) | conformance to customer requirements |
| c) | the characteristics of process |
| d) | supplier performance |
MRPC shall continually
improve the quality system. This process describes the continual improvement of
QMS through the use of the quality policy, objectives, audit results, analysis
of data, corrective and preventive action and management review.
MRPC has established and
maintains DOP.QA.004, DOP.QA.005 and DOP.QA.006
for eliminating the causes of product and process non-conformity in order to
prevent recurrence. Corrective actions taken are appropriate to the impact of
the problems encountered. These procedures define requirements for:
| a) | identification of non-conformities, including customer complaints |
| b) | determination of the causes of non-conformities |
| c) | evaluation of the need for actions to ensure that non-conformities do not
recur |
| d) | determination and implementation of corrective actions needed |
| e) | recording the results of actions taken, ref.
DOP.QA.008 |
| f) | reviewing the corrective action taken |
MRPC has established and
maintains documented quality plans and methods for eliminating the causes of
potential non-conformities to prevent occurrence in conjunction with
DOP.QA.004,
DOP.QA.005, and DOP.QA.006.
Preventive actions taken are appropriate to the impact of the potential
problems. Quality plans and the procedures define requirements for:
| a) | identification of potential
non-conformities and their causes |
| b) | determination and implementation of preventive action needed |
| c) | recording results of action taken ref.
DOP.QA.008 |
| d) | reviewing of actions taken. |
|
Rev |
Description
of change |
Master
verified |
Date |
|
Draft |
Transition
to ISO9001:2000 |
|
|
|
-1- |
Reviewed
& revised to recommendations per audit reports dated |
|
|
|
|
|
Renato Alpizar |
02/25/03 |
|
|
Revised Reference Documents 4.2.3,5.3(e), 5.4.1, 6.1, 6.2, 7.1, 7.5.2, 7.5.3, 8.2.2, 8.3, 8.5.3 |
Sue Lloyd |
09/09/03 |
|
|
|
|
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