QMS - Definitions

A systematic and independent examination of quality and related activities that will determine compliance with planned objectives

An examination conducted by a Business/Organization's own personnel to evaluate their Quality Systems Program. An internal audit is a form of self assessment.

is an in-depth examination of a specific manufacturing process and the implementation of such,in order to ensure compliance.

is a systematic examination effecting a: part, product, service or organization - prior to a contractual agreement, usually for qualification, approval, and registration purposes.

Audits (Quality Audits) vs. Surveillance: Quality Audits are used as a "spot check/snapshot" to evaluate the need for Quality Improvements or Corrective Action. Quality Audits are not a substitute for - and should not be confused with Surveillance. Surveillance is the "ongoing process" used to ensure that inspection activities relating to process control or product acceptance is carried out appropriately - meeting both contractual and regulatory requirements.

Contract Requirements: A contract is a written legally binding agreement between two or more parties. This agreement should: (a) be specific in nature, (b) outline all the requirements and specifications, (c) have a definite price (or maximum capped price), (d) have a definite delivery date (or completion date), and (e) be signed as acceptable by all parties involved. Note: Each party should receive an original signed copy.

Corrective Action: An action taken to eliminate the causes of an existing nonconformity, defect, or other undesirable situations, to prevent recurrence.

Documentation: In order to establish a quality management systems program, it is imperative that all activities relating to the product be documented. It is also imperative that the documentation, be organized in a fation that makes it possible to trace all material - form the time the material arrives at the facility, to the the time the material leaves the facility.

Product Realization: Using th Concepts and Principles of Quality Management Systems, the organization shall plan, develop and implement the processes nessary (consistent with contractual and regulitory requirements) to ensure that quality objectives are met for the required product.

Quality: Are the characteristics, including performance, of an item, product or service that bear on its ability to satisfy stated or implied needs.

Eg. (a) "fitness for use", (b) "customer satisfaction", or (c) "conformance to the requirements".

Quality Audit: A systematic and independent examination of quality and related activities that will determine compliance with planned objectives

Quality Audits vs. Quality Surveillance: Quality Audits are used as a "spot check/snapshot" to evaluate the need for Quality Improvements or Corrective Action. Quality Audits are not a substitute for - and should not be confused with Quality Surveillance. Quality Surveillance is the "ongoing process" used to ensure that inspection activities relating to process control or product acceptance is carried out appropriately - meeting both contractual and regulatory requirements.

Quality Management Tools: Measurement Tools are an integral component to the Continual Improvement Process of an ISO 9001:2000 Quality Management Systems Program.

The Cause and Effect Diagram was developed to represent the relationship between some “effects” and all the probable “causes” influencing it.

The Cause and Effect Diagrams are drawn to clearly illustrate the various causes effecting a process by sorting out and relating the causes. For every effect there are likely to be several major categories of causes.

The Check Sheet is used for gathering data based on sample observations in order to establish patterns. Check sheets are used to determine how often particular events occur.

2. Determine what type of system should be used for data collection. E.g. every time the event in question happens, by batch or time period etc..

The Pareto Chart is a special form of vertical bars in a graphic format which helps determine which problems to solve and in what order to address them.

Check Sheet data can easily be converted over to a much more manageable format using the Pareto Chart.

The Pie Chart is a graph where the whole 360 degree circle represents 100% of the data to be displayed.

The circle or pie is divided into slices or percentages. This type of approach can be very useful for visual representations of data.

The Run Chart is used to visually represent data. It is used to monitor a process to see whether or not a long range average is changing.

Run Charts are the simplest tools to construct and use. Points are plotted on a graph in the order in which they become available.

It is common to graph the results of a process such as machine down time, yield, scrap , typographical errors or productivity as they vary over time.

Quality Manual: The Quality Manual should contain, the Quality Policy, the responsibilities, authorities, and interrelationships of personnel who manage, perform, verify or review work affecting Quality, the Quality System Procedures and instruction, a statement for reviewing, updating and controlling the Quality Manual.

A Quality Manual can vary in depth and format to suit the needs of an organization.

Quality Plan: A document setting out the specific quality practices, resources and sequence of activities relevant to a particular product, project or contract.

Quality Policy: The overall quality intentions and direction of an organization regarding quality, as formally expressed by top management.

Quality Procedure: A specific way of accomplishing an activity, an established way of doing things, a series of steps followed in a definite regular order, to ensures the consistent and repetitive approach to activities.

Quality Product: A quality product is an output that is a result of a specific set of processes and procedures. It should be noted that there must be consistency in manufacturing, and that the product (or service) should consonantly meet contractual (customer) requirements.

Quality Requirements: A translation of customers stated requirements into a set of quantitatively or qualitatively measurable steps or characteristics. This will produce a product or service meeting customer requirements according to the contractual terms (documented) of the customer.

Traceability: For tracking and traceability purposes, it is imperative that all transfer points of the manufacturing/distribution process be signed and dated by the individual responsible at the particular work centre involved (meeting both the giver and receiver). The transfer point from the manufacturer/distributor to the purchaser should also be included in this procedure.

Work Instructions: Specific operational activities carried out to produce the product or service.

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