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Terms relating to Conformity in QMS

We shall try to define and understand some of the terms used in quality management system. The standard ISO 9000:2005 is the basis on which the terms are defined.

6) Terms relating to Conformity

Terms relating to Conformity as defined in ISO 9000:2005 are:

6.1) Conformity

ISO 9000 definition:
“Fulfillment of a requirement”
NOTE The term “conformance” is synonymous but deprecated.

Explanation:

Conformity is the “fulfillment of a requirement”. To conform means  to meet or comply with requirements. There are many types  of requirements. There are quality requirements, customer requirements, product requirements, management requirements, legal requirements, and so on.Requirements can be explicitly specified (like the ISO 9001  requirements) or implied. A specified requirement is one that has been stated (in a document, for example). When your organization meets a requirement, you can say that it conforms to that requirement.

6.2) Nonconformity

ISO 9000 definition:
“Non-fulfillment of a requirement”
Explanation:

Nonconformity is the “non-fulfillment of a requirement”.Nonconformity refers to a failure to comply with requirements.A nonconformity  is a deviation from a specification, a standard, or an expectation.  A requirement is a need, expectation, or obligation. It can be stated or implied by an organization, its customers, or other  interested parties.  There are many types of requirements. Some of these include quality requirements, customer requirements, management requirements, product requirements, and legal requirements. Whenever your organization fails to meet one of these requirements, a nonconformity occurs. ISO 9001 lists quality management system requirements. When your organization deviates from these requirements, a nonconformity occurs.  Nonconformities are classified as either critical, major, or minor.

  • Minor nonconformity – Any nonconformity which does not adversely affect the performance, durability, interchangeability, reliability, maintainability, effective use or operation, weight or appearance (where a factor), health or safety of a product. Multiple minor nonconformities when considered collectively may raise the category to a major or critical nonconformity.

  • Major nonconformity – Any nonconformity other than critical, which may result in failure or materially reduce the usability of the product for the intended purpose (i.e. effective use or operation, weight or appearance (where a factor), health or safety) and which can not be completely eliminated by rework or reduced to a minor nonconformity by an approved repair.

  • Critical nonconformity – Any nonconformity which may result in hazardous or unsafe conditions for individuals using, maintaining or depending upon the product or prevent performance of a vital products.

6.3) Defect

ISO 9000 definition:

“Non-fulfillment of a requirement related to an intended or specified use”
NOTE 1 The distinction between the concepts defect and nonconformity is important as it has legal connotations, particularly those associated with product liability issues. Consequently the term “defect’ should be used with extreme caution.
NOTE 2 The intended use as intended by the customer can be affected by the nature of the information, such as operating or maintenance instructions, provided by the supplier .

Explanation:

ISO/IEC 9126 distinguishes between a “defect” and a “nonconformity”, a defect being the non-fulfillment of intended usage requirements, whereas a nonconformity is the nonfulfilment of a requirement. In a product more than one defect may be present and a relatively small number of minor defect may be acceptable to the customer.Product quality may be described by the total number of defect or total number of defect per unit. Defect and nonconformity are the two terms which are used synonymously. A non conformity is defined as a failure of quality characteristics to meet its intended level or state, occurring with severity sufficient to cause the product not to meet a specification. A defect is  a non conformity severe enough to cause the product not to satisfy normal usage requirement. Thus the difference between defect and nonconformity is only perspective.Non conformity is defined based on specification and defect is defined on based on fitness of use.  Since the term defect may have a legal  connotations, they should be used with extreme caution. Defects can be classified as Minor, Major, Serious and critical defects.

  • Critical defect may lead directly to severe injury or catastrophic economy loss.
  • Serious defect may lead to injury or significant economy loss.
  • Major defect may cause major problems during normal use. A major use will likely result in reducing the usability of the product.
  • Minor defect may cause minor problems during normal use.

6.4) Preventive action

ISO 9000 definition:

“Action to eliminate the cause of a potential nonconformity or other undesirable potential situation.”
NOTE 1 There can be more than one cause for a potential nonconformity.
NOTE 2 Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.

Explanation:

Preventive actions are steps that are taken to remove the causes of potential nonconformities or  potential situations that are undesirable.The preventive action process is designed to prevent the occurrence of nonconformities or situations that do not yet exist. It tries to prevent occurrence by eliminating causes.  While  corrective actions  prevent  recurrence, preventive actions  prevent  occurrence. Both types of actions are intended to prevent nonconformities. Preventive actions address potential problems, ones that haven’t yet occurred. In general, the preventive action process can be thought of as a risk analysis process. Preventive actions are implemented in response to the identification of potential sources of non-conformity. Preventive action is prediction of problem and trying to avoid the occurrence (fail safe) through self initiated actions and analysis related with processes/ products. This can be initiated with the help of active participation of staff members/workers through improvement teams, improvement meetings, management review, customer feedback and deciding own goals quantized in terms of business growth, reducing rejections, utilizing the equipment effectively, etc.

6.5) Corrective action

ISO 9000 definition:
“Action to eliminate the cause of a detected nonconformity or other undesirable situation.”
NOTE 1 There can be more than one cause for a nonconformity.
NOTE 2 Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence.
NOTE 3 There is a distinction between correction and corrective action.

Explanation:

Corrective actions are steps that are taken to eliminate the causes of existing nonconformities in order to prevent recurrence. The corrective action process tries to make sure that existing nonconformities and potentially undesirable situations don’t happen again.Corrective actions are implemented in response to customer complaints, unacceptable levels of product non-conformance, issues identified during an internal audit, or adverse or unstable trends in product and process monitoring such as would be identified by SPC. Corrective action is a reaction to any of the cause/non-conformance mentioned above and can be divided in two phases of action:

1) Identification of root cause: Total Quality Management  tools such as fish-bone or cause and effects analysis can be practiced. Corrective Action is appropriate and effective if and only if the root cause of problem(s) has been identified.

2) Taking necessary actions: The effectiveness of the corrective action taken has to be verified periodically through a systematic approach of PDCA (plan-do-check-act) cycle.

6.6) Correction

ISO 9000 definition:
“Action to eliminate a detected nonconformity.”
NOTE 1 A correction can be made in conjunction with a corrective action.
NOTE 2 A correction can be, for example, rework or regrade .

Explanation:

A correction is any action that is taken to eliminate a nonconformity. However, corrections do not address causes. When applied to products, Corrections can include reworking products, reprocessing them, regrading them, assigning them to a different use, or simply destroying them.Correction is like first-aid, its the instant action that is taken to correct the nonconformity or to reduce the impact nonconformity that has occurred.

6.7) Rework

ISO 9000 definition:
“Action on a nonconforming product to make it conform to the requirements.”
NOTE Unlike rework, repair can affect or change parts of the nonconforming product.

Explanation:

The reprocessing of nonconforming material to make it conform completely to the drawings, specifications or contract requirements.Bringing a non-conforming part back into conformance by simply reprocessing a prior sequence.

6.8) Regrade

ISO 9000 definition:
“Alteration of the grade of a nonconforming product in order to make it conform to requirements differing from the initial once.”
Explanation:

Nonconforming items that can’t be repaired must be controlled. However, just because the item is nonconforming for one purpose does not mean it cannot be used for another purpose. Regrading refers to re-purposing the item for a different use than its original, as long as it meets the quality standards for the new use category. Proper documentation is required if using this disposition.

6.9) Repair

ISO 9000 definition:
“Action on a nonconforming product to make it acceptable for the intended use.”
NOTE 1 Repair includes remedial action taken on a previously conforming product to restore it for use, fix example as part of maintenance.
NOTE 2 Unlike rework, repair can affect or change parts of the nonconforming product.

Explanation:

The reprocessing of nonconforming material in accordance with approved written procedures and operations to reduce, but not completely eliminate, the nonconformance. The purpose of repair is to bring nonconforming material into a usable condition. Repair is distinguished from rework in that the item after repair still does not completely conform to all of the applicable drawings, specifications or contract requirements. Bringing a non-conforming part back into conformance using methods outside the original process.

6.10) Scrap

ISO 9000 definition:
“Action on a nonconforming product to preclude its originally intended use.”
EXAMPLE Recycling, destruction.
NOTE In a nonconforming service situation, use is precluded by discontinuing the service.

Explanation:

Nonconforming items that can neither be reworked nor regraded are essentially unusable for manufacturing purposes. These items should be scrapped to prevent introducing them to the supply chain. Scrapping an item does not necessarily require it be thrown in the trash; some items, such as some metals and paper, can be recycled. The firm can recoup a small portion of the manufacturing cost of the nonconforming product from the recycling proceeds. If this disposition is used, the company should document it accordingly.

6.11) Concession

ISO 9000 definition:
“Permission to use or release a product that does not conform to specified requirements”
NOTE A concession is generally limited to the delivery of a product that has nonconforming characteristics within specified limits for an agreed time or quantity of that product.

Explanation:

Items that have a very minor nonconformity may be allowed to be introduced to the supply chain. Such an item must have no negative impact on the form or function of the finished product. This disposition should also be documented according to ISO rules.

6.12) Deviation permit

ISO 9000 definition:
“Permission to depart from the originally specified requirements of a product prior to realization”
NOTE A deviation permit is generally given for a limited quantity of product or period of time, and for a specific use.

Explanation:

Deviation Permit may be defined as a specific written authorization, granted prior to the manufacture of an item, to depart from a particular requirement(s) of an item’s current approved configuration documentation for a specific number of units or a specified period of time. A deviation differs from an engineering change in that an approved engineering change requires corresponding revision of the item’s current approved configuration documentation, whereas a deviation does not.  Deviation Permit is a permission to depart from the originally specified requirements of a product prior to realization.  A deviation permit is generally given for a limited quantity of product or period of time, and for a specific use. Therefore, if you haven’t made the product yet, but you know it won’t meet requirements when you do, you’ll need a deviation permit. From this definition we can imply that a Deviation is a departure from originally specified requirements.
A deviation is a departure from standard procedures resulting in non-conforming processes or where there have been unusual or unexplained events which have the potential to impact on customer product quality, system or process integrity or personal safety. For  sake of continuous improvement, these deviations are recorded in the form of Deviation Report (DR).Deviations may be planned or unplanned.

  • An unplanned deviation is a deviation that is discovered after the procedure has been carried out.
  • A planned deviation occurs when an unexpected event prevents a procedure from being followed exactly as written. Such deviations must be authorized  before they are implemented and are expected to be short-term solutions to a problem with immediate impact.

6.13) Release

ISO 9000 definition:
“Permission to proceed to the next stage of a process”
NOTE In English, in the  context of computer software, the term “release” is frequently used to refer to a version of the software itself.

Explanation:

Product realization is the process of  defining, designing, developing, and delivering products to the market. This is done by   following a set of product realization processes.  Product  realization refers to all the processes that are used to bring products into being. To move from one stage to another appropriate permission may be need by appropriate authorized person.

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