KPQPM Kenson Quality Policy / Quality Manual Page 2 of 27
3.0 TERMS AND DEFINITIONS
3.1 CONTEXT OF THE ORGANIZATION: refers to the business environment of the organization
which can be considered a combination of internal and external factors and conditions
that can have an effect on an organization’s approach to its products, services,
investments and interested parties.
3.2 COUNTERFEIT PART: An article misrepresented as a specified genuine item, from an
authorized manufacturer; or a previously used material or a part which has been
modified and is knowingly, recklessly, or negligently misrepresented as new without
disclosure to the customer that it has been previously used.
3.3 CRITICAL ITEMS: Those items (e.g. functions, parts, software, characteristics, processes)
having significant effect on the provision and use of the products/services provided.
Critical items require specific actions to ensure they are adequately managed. Kenson
Plastics considers critical items to be those identified as Key Characteristics.
3.4 KEY CHARACTERISTICS: An attribute or feature whose variation has a significant effect
on product fit, form, function, performance, service life, or producibility, that requires
specific actions for the purpose of controlling variation. Kenson Plastics considers
attributes which affect the fit form, function, safety, and cosmetic application of the
product to be key characteristics.
3.5 PRODUCT SAFETY: The state in which a product is able to perform to its designed or
intended purpose without causing unacceptable risk of harm to persons or damage to
property. Kenson Plastics manufactures to customer design which includes utilizing the
customer specifications regarding the materials from which the products are created.
When applicable, Kenson Plastics will apply customer as well as statutory and regulatory
safety requirements to all products it manufactures. Kenson demonstration of
compliance can include but is not limited to flammability certificates; breaking sharp
edges; RoHS, REACH, Proposition 65 certificates as well as conformance to
International Standards for Phytosanitary Measures (Reference: ISPM 15) of pallets.
3.6 SPECIAL REQUIREMENTS: Those requirements identified by the customer, or determined
by the organization, which have high risks of not being met, thus requiring their inclusion
in the operational risk management process.
4.0 CONTEXT OF THE ORGANIZATION
4.1 OVERVIEW
4.1.1 Kenson Plastics Inc. is a premier manufacturer of precision pressure-formed and
vacuum-formed plastics since 1972, specializing in engineered plastic
components and enclosures primarily for the medical, electronic, and
transportation industries. Cost-effective solutions combine thermoforming,
complex machining and unsurpassed fabrication work to meet the most exacting
engineering and aesthetic requirements.
4.1.2 Kenson Plastics top leadership has determined relevant external and internal
issues and their impact to achieve the intended results of their QMS. These
issues are monitored, and the data is reviewed through various vehicles to
include but not limited to Management Review Meetings; Key Performance
Indicators (On Time Shipments, Parts Per Million, etc.); Continuous Improvement
Measurables (i.e. Corrective Actions, etc.); Stakeholder Feedback (i.e.
scorecards, surveys, complaints, etc.); and other quality and safety team
activities and their results.
4.1.3 The Kenson Plastics mission is to become a market leader in providing high
quality custom pressure formed products through innovative and collaborative
implementation of customer designs; via a thorough understanding of customer’s
finish and functionality requirements, and the commitment to providing quality