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Quality Management System – Engineering and Management
Table of Contents - Detailed Version
Purpose and scope
Quality system engineering
Quality system management
Acting in an advisory, training, quality-promoting and quality assurance capacity
§ Purpose and scope
× Spanning all formalized aspects of conducting an organization’s core business processes relative to quality planning, quality monitoring and control along with quality assurance, and quality improvement.
› With the ultimate goal of continuing customer satisfaction at improved performance.
- Customer satisfaction includes that of each person’s “internal” customers as well as those of the organisation as a whole.
§ Quality system engineering
× Objective.
› Building an effective and audible Quality System (QS) within a given timeframe, that can achieve the planned results and meets the requirements of the ISO standards for certification / registration.
- Establish an overall Quality System development and application schedule covering all stages.
× Stages.
› Evaluation: Assessment of the current quality status. Determination of the scope of the project.
- Determining the extent to which present activities satisfy all the Quality System requirements.
- Establishing a rank order of priorities.
- Schedule for development or expansion/ revision for those requirements not or not fully covered by current documented programs / processes.
› Development of three-layer Quality System documentation. This includes:
- Development of written procedures along with the needed supportive materials (technical documents, templates, forms, checklists, user guides etc), and training programs.
ê As each item is developed, it is tested in its environment along with the training of the involved personnel to assess its effectiveness and change if required.
- Development and writing of the high-level, stand-alone Quality Assurance Manual.
- Development of an inspection procedures manual, supplemental by product / process inspection manuals, along with other intradepartmental technological manuals.
› Implementation: Quality System tryout / testing processes / conduct of pilot-runs.
- Development of a written plan for the implementation phase, considering the following:
ê The selected areas that will thoroughly try out the new or modified practice, with
ê Prior agreement of all involved groups.
ê Built-in detection and notification methods to cover any problems.
ê A schedule for frequent assessment of progress towards complete application of the new practice in the pilot-run situation, as well as a
ê List of actions to be completed according to that schedule.
- Leading the implementation / testing phase (as writer / writing group leader), to ensure:
ê An effective and efficient pilot-run.
ê Necessary alterations of the program / documents when indicated, or
ê Release of the program / documents for full-scale application.
- The testing activity results either in alteration of the program when indicated or in its release for full-scale application.
› Full-scale installation / operation.
- Drawing up realistic / revised schedules, compatible with the initially established development / application plans, thereby making allowances for:
ê Trade-offs to be made between the application schedules and the realization of the benefits of the new quality system, considering.
ê That the time required for a successful release of all quality system documents is influenced by the organization’s resistance to change and its ability to absorb change.
ê The conduct of training programs, perhaps covering several documents in one program before release of documents.
- The completion of the full-scale application effort for all elements / requirements.
ê With configuration management applied to all released documents.
• Quality system management
× Of concern at all stages, not just after completion of the installation efforts for all elements.
× Coordination of all activities to assure the achievement of the required results and benefits.
× Promoting quality achievement and performance improvement throughout the organization.
× Provide leadership to ensure the effective use of the quality system as a specific factor to reach continuing customer satisfaction at improved performance and reduced cost.
× Motivating reluctant staff to change their way of working and incorporate quality methods.
× Provide intra-company liaison on the quality system.
× Provide / obtain priority decisions for QS activities when they compete with other programs for resources.
× Assure, as appropriate, the effective visibility of the quality system to customers and other relevant groups.
× Setting QA compliance objectives and ensuring that targets are achieved.
× Development and application of a proper QA program for evaluating the continuing health of the Quality Management System QMS:
(i) Involving independent audits, departmental QA activities and support for QS activities, both directed at encouraging / creating a QS commitment throughout all functions, resulting in
(ii) Obtaining the benefits of the QMS: increased customer satisfaction at reduced costs and improved performance.
› The audit to serve as preliminary evaluation, followed by in depth investigations through the involved groups / functions.
- Audits of all types scheduled, held and the results followed up.
- Since many of the audits involve multifunctional teams.
ê Provisions for obtaining and rotating the audit team personnel must be made.
› The support aspect through technical assistance to all functions involved:
- To facilitate the implementation and effective operation of the Quality System, and
- To reduce the resistance to change.
› Support activities include:
- Provision of guidelines for effective writing of standard operating procedures to be incorporated into the documentation system to be established.
- Preparation of technical bulletins for the entire organization.
- Distribution of explanatory material about the Quality System and how to install it.
- Personal assistance and consulting to managers of all functions in overcoming any obstacles in the day-to-day application of the QS provisions in their activities.
- Providing effective training, tools and techniques to the personnel involved to enable them to achieve an improved performance and assure the success of the Quality System.
- Consulting assistance and executive reports to senior management to support their endeavours.
ê That the operation of the QMS receives the same strategic treatment as other key business activities.
× Ensuring compliance with national and international standards and legislation.
× Liaising with external parties / bodies on matters relating to the quality system.
× Liaising with customers’ auditors and ensuring the execution of corrective action and design changes in compliance with customers’ specifications.
× Assessing suppliers’ and own company’s product specifications and customer requirements.
× Working with procurement staff to establish quality and reliability requirements from external suppliers.
× Baseline documentation: setting up and configuration management.
× In-depth QMS related consulting assistance to upper management.
• Acting in an advisory, training, quality-promoting and quality assurance capacity
× Establishing procedures for maintaining high standards of quality and reliability.
× Implementing statistical process controls.
× Establishment of QC / QA programs, including
› Manufacturing data system adequate to report defects and yields.
› QA failure analysis system, and a database for device selection.
› Defect prevention program.
× Review the effectiveness of corrective action programs.
× Ensure effectiveness of the system audit program and quality information feedback.
× Identifying relevant quality-related training needs. Training in various quality-oriented skills, techniques and tools.
› Overall training in Quality System subjects: e.g. concepts and procedures, management of the QMS through its control mechanisms, selected statistical control techniques.
› Functional management and technical personnel training.
- To provide the basis for thorough understanding, acceptance and practice of pertinent QS and quality control programs and techniques, such as
ê Statistical analysis of data.
ê The use of audits for control purposes.
ê Techniques of problem-solving, including 8D approach.
› Quality data and information programs, establishment and coordination:
- Manufacturing data system adequate to report defects and yields.
- Quality assurance failure analysis system.
- Quality engineering, process inspection and control program.
- Failure reporting, analysis and corrective action system.
- Defect prevention program.
× Product and / or process change management and notification. Configuration management.
× Establishing a quality information system, including
› Product design test data.
› Information on purchased parts and materials.
› Process data incl. inspection and test, process controls and process capability data.
› Field performance data.
› Configuration control data.
› Results of audits, incl. product audits and system audits.
× Providing for continuously measuring and monitoring customer product quality satisfaction, including
› Adequate levels of inspection and testing as a basis for immediate corrective action.
× Analysis of costs of poor quality. Identification of major opportunities for improvement.
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