ISO Preventive Action Procedure | QP1050

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easily editable in ms wordISO Preventive Action Procedure

The ISO Preventive Action Procedure increases process capability throughout your company. It describes methods for identifying potential nonconformities in your company’s Quality Management System (QMS) and for preventing, or reducing the likelihood of, their occurrence.

Preventive actions may be taken at any point in time for any process; there, this procedure applies to all processes within your company’s QMS (production, customer service, etc.). (10 pages, 1256 words)

ISO Preventive Action Responsibilities:

Quality Management is responsible for using quality data analysis to identify potential nonconformities, ensuring that preventive actions appropriate to the nature of the potential nonconformities are taken, and ensuring that preventive actions yield the desired results.

The Quality Improvement Team is responsible for investigating potential nonconformities and developing preventive actions appropriate to the level of risk posed by the nonconformity.

Quality Management is responsible for initiating preventive actions and following up on them at Management Review Meetings.

ISO Preventive Action Definitions:

Failure Mode and Effects Analysis (FMEA) – Technique for testing design of products in which failures are assumed to occur. FMEA is useful for evaluating reliability, safety, and general quality where the evaluator assumes that:

  • Each component fails;
  • Each subsystem or subassembly fails;
  • The operator makes errors; and/or
  • The power source is interrupted and immediately restarted.

The probability of each failure occurring and the result of failure are analyzed. If possible, hazards and faulty performance are designed out of the device; if not, hazards/substandard performance are compensated, reduced, or prevented (by interlocks, warning signs, explicit instructions, alarms, etc.). Risk of failure cannot always be removed from products but can be understood and controlled to the extent possible with existing technology.

Preventive Action – Measure put in place to eliminate, or reduce the likelihood of, a potential nonconformity.

Process Capability – Ability of a process to produce a defect-free product or service during normal operations. Process capability is measured in terms of Cp, Cpk, or Cpm indices. A higher process capability index means greater process capability; an index of 1.0 or greater is desired.

Quality Function Deployment (QFD) – Structured approach to:

  • Defining customer needs or requirements; and
  • Translating needs into specific plans to produce products to meet those needs.

The voice of the customer – stated and unstated customer needs or requirements – is captured in a variety of ways (direct discussion or interviews, surveys, focus groups, customer specifications, direct observation, warranty data, field reports, etc.). This is summarized in a product planning matrix ” a “house of quality”.

Houses of quality are used to translate higher-level “whats” (needs) into lower-level “hows” (product requirements or technical characteristics that satisfy the needs).

Quality Improvement Team (QIT) – A cross-functional team chartered with the task of identifying the cause(s) of potential nonconformities and implementing actions necessary to eliminate or reduce their likelihood.

ISO Preventive Action Procedure

ISO Preventive Action Procedure Activities

  • Background
  • Risk Analysis Evaluating the Need for Preventative Action
  • Determining Actions Required and Implementing Them
  • Preventative Action Review

ISO Preventive Action Procedure References

  • ISO 9001:2008, “Quality Management Systems – Requirements”, International Organization for Standardization (ISO), Nov., 2008.
  • Quality Procedures

ISO Preventive Action Procedure Forms



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