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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 Registration

In 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:

  1. A company quality policy: Written material, explanation and guidance will be provided by H&F during the development of the quality policy.

  2. 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.

  3. 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.

  4. 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.

  5. An internal audit system: Documented procedures will be developed describing the internal audit function with responsibilities, plans, reports and actions defined.

  6. 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.

  7. 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.

  8. 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.