What is the concession and deviation process?

A concession is a documented event of non-conformance identified once the part has been manufactured, and covers one part or a batch of parts. A deviation permit is usually a premeditated intent to make a part away from the requirements defined in the drawing or specification prior to manufacture.

What is a concession request form?

Concession Request means any request for deviation from the COMPANY requirements, either by the CONTRACTOR or SUPPLIER, usually after receiving the Contract package or Purchase Order.

What is a deviation in ISO?

Deviation: a planned process outside of a defined procedure. Typically used to control an undesired process state, or to evaluate a potential process/product change. (traditionally there are planned and unplanned deviations, but I lump unplanned to NC's). Concession: Is right out of ISO (see ISO 13485 8.3.

What is a concession in production?

A concession is a form of permission given to use or release (see disposition) a product (or service) that does not conform to specified requirements. This permission is generally only allowed within specified limits, and for a limited quantity, or time, or specified use.

What is the difference between a deviation and a concession?

A deviation permit is generally given for a limited quantity of products and services or period of time, and for a specific use. In contrast, a concession is the post-realisation equivalent of a deviation permit.

What is a concession in quality assurance?

A concession is a special approval that is granted to release a. nonconforming product or service for use or delivery. Concessions. are usually restricted to a specific use and limited by time and quantity. and tend to specify that nonconforming characteristics may not violate.

What is a concession in pharmaceutical industry?

3.6. 11 concession: 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 non- conforming characteristics within specified limits for an agreed time or quantity of that product.

What is a deviation form?

The Deviation Request Form is used to request for a process or product deviation. These. deviations are temporary and are used to document the deviated from requirement. condition. Deviations can apply to any defined requirement whether it be product or process.

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Deviationconcession Approval Form

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Zodiac Aerosafety Evacuation Systems Division Form 021490 Rev. H DEVIATION/CONCESSION APPROVAL FORM SUPPLIER: P/N: Rev#: ADDRESS: DESCRIPTION: Qty. Affected: PHONE: S/N/Lot#: DEVIATION/ CONCESSION.

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