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QUALITY SYSTEMS DEVELOPMENT
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CONSULTING ENGINEERS
Materials, Metallurgical and Mechanical Engineering Quality Assurance, Corrosion, Failure Analysis |
R.A. HOFFMANN ENGINEERING, P.C. D/B/A HOFFMANN & FEIGE Croton River Executive Park, 3 Fallsview Lane Brewster, NY 10509 Phone: (845) 277-4401 Fax: (845) 277-4701
Send email to metalmen@hoffmann-feige.com
Achieving RegistrationIn
order to achieve the objective of a quality management system
registered to any one of the ISO 9000 standards, the following complete
package of training and implementation is available from H&F. All
of the components, or any portion of those shown below, can be selected
by clients, as required, to meet individual quality system development.
We can perform a gap assessment and provide a report indicating where
an organization may need to enhance it's existing system with
recommendations for providing the guidance and direction to obtain
compliance to any of the ISO 9000 platforms. Executive Overview Training The
overview of an ISO based quality System consists of explaining the
basic requirements of the standard, the approach to implementation,
management, and employee involvement in the certification process. The
registration process is explained along with the depth of the
documentation requirements. Employee Overview Employee
training consist of awareness education and what a quality system can
do for the company and the employees. The topics discussed includes the
reasons for pursuing this program, the expected changes in the
buisiness system and ways in which these changes will be a positive
step in the organization's growth. Develop a Documented Quality System H&F
will develop a program plan that defines tasks with milestone dates.
Based on this plan, H&F will define and develop four levels of
management system documentation, consisting of the corporate quality
manual, standard operating procedures, work instructions and the
associated forms that constitute your formal records. This will also
include all corresponding flow charts, process maps, and a business and
quality plan. Within this documented quality system, the following subsystems will be developed: - A
company quality policy: Written material, explanation and guidance will
be provided by H&F during the development of the quality policy.
- A
company business plan: A number of standard baseline requirements will
be captured in the company business plan. This will be developed to
include job descriptions, quality planning, and company capital
equipment.
- A
document control system: A system will be developed for controlling all
quality system documents, including specifications and records. Change
control, document history and a method for determining distribution and
current document status will evolve.
- A
calibration system and preventive maintenance process: For product
suppliers, the basis for a sound dimensional verification system is
founded on the accuracy of their measuring devices and the consistent
capability of their process equipment. Accordingly basic and effective
documented procedures will be developed for providing the
implementation and control of these elements.
- An
internal audit system: Documented procedures will be developed
describing the internal audit function with responsibilities, plans,
reports and actions defined.
- Procurement
System: A purchasing procedure will be developed that defines a system
to evaluate and rate suppliers as to their performance and ability to
meet specified requirements.Procedures for preparing a purchase order
will be defined with a method for verifying goods received.
- A
Nonconformance Control and Corrective and Preventive Action System:
Appropriate personnel will be trained in the documented system for
controlling nonconforming product and corrective and preventive action
that may result from product and process nonconformances.
- A
Process Control System: Client's production planning system will be
reviewed and the quality planning and verification system will be
developed around the system to ensure control of all production
processes. Processes, equipment and operators will be qualified.
Equipment will be maintained. Workmanship criteria will be specified
and operators will be trained in the criteria.
An Employee Training Program with Associated Job Descriptions In
order to ensure that employees are qualified for their assignments, job
descriptions are developed to establish minimum requirements. Training
needs are identified and training is provided to satisfy these needs to
ensure employees are qualified. H&F will develop a system with the
client to satisfy these essentials and provide the associated records
employed to verify training implementation.Internal Auditor Training The
standard requires an audit system with formally trained internal
auditors. The system will be based on the documented procedures
developed above. An H&F RAB Certified Auditor will train a group of
selected individuals. The training will consist of instruction on the
details of the standard, audit preparation and planning, focusing on
and gathering objective evidence, auditor skills and audit reporting. The
next phase is to provide the guidance and assistance in actual auditing
of the quality system. H&F will review and ensure the appropriate
responses have been raised and properly addressed. The effectiveness of
the audit results will be reviewed. Implement the Documented System It
is imperative that the program be undertaken organization wide. It
takes more than one or two people to promote a successful system. For
success to be achieved, upper management must play an active positive
role in the process. The implementation is the responsibility of the
client. The instructions are contained in the procedures that will be
compliant with the requirements of the standard. Remember that with
upper management support it should be easy to obtain employee buy-in to
ensure that they follow the procedures for a successful program.
H&F will guide upper management and train employees in the
procedures as appropriate during the implementation phase. Advice in the Selection of a Registrar Registrar
selection is a very critical matter to the continued success of the
program. Some say that a company's reputation for quality significantly
depends on the reputation of its auditor/registrar. The H&F team
will provide the client with recommendations and objective assistance
in the review and selection of an appropriate registrar. The client
will be developing a long-term partnership with the registrar;
selection is an important decision that should not be taken lightly. Assist in Preparation for Registration H&F
will provide an overview presentation to all employees on the subject
of what to expect during the registrar's audit during final
registration. This will prepare all employees, including upper
management for the final audit, so there will be no surprises and
everyone will be comfortable and successful during the event.
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