spring qms newsletter

Minute to Pen it Spring 2015

QMS Quality Management System

NAVSEA Standard Item 009-04 Provides the requirements of a Quality Management System

Terms

Audit

A systematic evidence gathering process

Continual Improvement

A set of recurring activities carried out to enhance performance.

Defect

A type of nonconformity

Nonconformity

a nonfulfillment or failure to meet a requirement.

Policy

General commitment direction or intention formally stated by top management.

MANAGEMENT - All the activities that are used to coordinate, direct, and control organizations.

Management & QMS NAVSEA Standard Item 009-04 paragraph 3.1.2 specifies

the responsibilities of management with regard to the Quality Management System. The first responsibility of management to the Quality Management System is commitment. Management commitment relates to the responsibility of an organizations top management to provide the leadership and direction within the organization. They must establish strategic quality management policies, directives and objectives consistent with the purpose and capabilities of the organization, as well as the establishment of an organizational structure and internal environment to motivate personnel to achieve the organization's quality management goals and objectives. Management must provide adequate resources to develop, implement, maintain and improve the QMS, and periodically review QMS performance to determine its suitability, adequacy and effectiveness.

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The purpose of management reviews is to gauge the health of the QMS. The review must determine QMS suitability, adequacy and effectiveness. Other questions which need to be answered;

Are QMS implemented resources and controls suitable and adequate for the QMS to be effective in achieving customer and regulatory requirements while achieving quality objectives;

Are further changes needed to improve the product or processes?

It is logical to have a process for management reviews, identifying specific requirements for management review inputs, value-adding review activities and outputs. The process should address the frequency, schedule, quorum and agenda for review meetings to be attended by top management.

For the management review process to be effective, top management must plan the review, all agenda items with some regularity and take timely action to change or improve any part of it, including the quality policy and objectives. To avoid problems on frequency and scope of review, an effective review should incorporate QMS agenda items into regular monthly or quarterly operational meetings.

Management review input should preferably be in summary form, showing QMS and operational performance measured against the business and quality plans, customer and regulatory objectives and goals. Appropriate actions must result from such reviews. Review decisions and actions must relate to improving products and processes or even creating new ones; providing more resources or perhaps improving the efficiency of existing resources; improving QMS controls; policies and objectives; and improving overall QMS effectiveness and customer satisfaction. Responsibilities and timelines should accompany these decisions and actions. The performance of these actions must be followed up at subsequent management review meetings. Performance indicators to measure the effectiveness of the management review process could include

Achievement of quality objectives; And improvement in customer satisfaction rating.

Customer Focus An organization depends on their customers. With

this in mind it is important to effectively manage customer relationships. Accordingly, you must understand the current and future needs of your customers, you must meet their needs and requirements and continually strive to surpass their expectations. To accomplish this goal you must understand your customers specific needs and requirements in terms of products, price, delivery communication, service and support.

Management Reviews

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After a review of the ISO 9001:2008, it is clear, top management is accountable and auditable for their roles and responsibilities within the QMS organization.

During an audit the phrase provide evidence is important. Auditors are expected to review records, which show top managements role in planning, implementing and maintaining the QMS. An Auditor will spend significant time verifying management is committed to achieving the requirements outlined in the QMS.

Management must begin by identifying the processes needed to meet the requirements of QMS. These processes will typically include:

Business planning; Quality planning; Management reviews; Internal communication; Organization structure; etc.

It is the responsibility of top management to communicate regularly to the organization on the importance of meeting customer and regulatory requirements. The communication process should clearly define what needs to be communicated;

To whom; The methods used; The frequency; And the means for determining

communication effectiveness.

Organizational communication may be accomplished in any number of ways including;

Meetings; Documented policies; Memos; Directives; Email; Computer, etc.

Effectiveness may be measured by asking, how much of the planned activities did the organization get done, and to what extent did

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we achieve planned results?

There is no requirement for a documented procedure to prove management commitment, However, the organization must identify and document (e.g. process map; process flow diagram; etc.) the processes for

Business planning; Quality planning; Management review; Internal communication; Organization structure; etc.

The organization must also identify the specific documents needed for effective planning, operation and control of these processes. These documents may include;

A documented procedure; Business plan; Statement of policies and objectives etc.

Look at the risks related to your business products processes and resources in determining the nature and extent of documented controls you will need.

The organizations QMS must identify the off-site (other than head office) processes within your QMS and ensure that such processes comply with ISO 9001 requirements. Evidence of compliance may include

a copy of their ISO 9001 certification; ISO 9001 internal audit results; auditing these processes at the off-site

facility

The expectation here is to have the relevant processes flow down to the off-site facility, and be performed just as they would in the main facility.

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spring qms newsletter

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