9.1 Control of Nonconforming Product
Quality System Procedure
9.1 Control of Nonconforming Product
Rev-00 / Date 06-19-07 - Approved by: John Bowman
1.0Purpose and Scope
This procedure establishes the method to report, disposition, and respond to suspected product nonconformance. It applies to all CT BioEnergy LLCbiodiesel related operations.
1.1Definitions
MRB: Material Review Board which reviews and dispositions suspected nonconforming products.
Nonconformance: A deficiency in characteristic, documentation or procedure which renders the quality of an item unacceptable or indeterminate. Examples of nonconformances include: out of specification condition, test failures, incorrect or inadequate documentation, or deviation from prescribed processing, inspection or test procedures.
Accept: Accept as-is, analysis has determined no nonconformance
Rework: A nonconformance disposition whereby a nonconforming product is made to conform to a prior specified requirement by completion, reprocessing, or other corrective means.
Reclassify: Reclassify product for another application
Scrap: Product: Product cannot be reworked, and must be isolated & scrapped.
2.0Procedure
In the event a suspected nonconforming condition relating to product is detected, a Nonconformance Case shall be created and submitted to the Material Review Board(MRB) for disposition. The MRB has full authority to make decisions for their respective organizations. The MRB also has the responsibility for requesting Corrective Action (ref QSP 10.1), when applicable.
2.1MRBTeam Assignments
The board consists of a Quality chairman, permanent members with authority from key functional areas (e.g. quality, engineering, operations), and temporary members. For each case, the permanent MRB can assignee temporary team members which have knowledge of the problem and/or the resolution.
2.2Nonconformance Identification
2.2.1Anyone who detects a suspected nonconforming condition shall be responsible for properly identifying that condition by initiating Nonconformance Case.
2.2.2When product is suspected to be nonconforming, it must be conspicuously identified and controlled to prevent its inadvertent use. The suspect lot shall not be moved/relocated until a disposition is made by the MRB.
2.2.3The nonconformance case is forwarded to the MRB for review and disposition.
2.3Nonconformance Disposition
2.3.1The MRB is responsible to review the problem and determine required actions.
2.3.2There are fourdispositions applicable.
- Accept
- Rework
- Re-classify (to another application)
- Scrap
2.4Nonconformance Actions
2.4.1The disposition of “rework”, shall be accompanied by rework instructions, completed by the MRB. Reworked product shall be reinspected in accordance with the standard inspection procedures (QSP 8.3).
2.4.2The MRB is responsible for appropriatelydistributing case findings, initiating appropriate action and retaining nonconformance case records.
2.4.3Customer Support shall be involved with nonconformance cases involving delivered products. Corrective action requires notification of customer and possible recall or other actions.
2.4.4If the disposition of nonconforming product renders it different from customer specification, customer notification may be required. Customer Support shall notify the appropriate customer contact.
3.0Responsibilities
3.1The MRB is responsible to review and authorized to “sign-off” on the disposition of nonconforming product.
3.2All Employees who detect a suspected nonconforming product or material are responsible to initiate a nonconformance case.
3.3Quality is responsible for the maintenance and implementation of this procedure.
3.4Operations is responsible for implementing corrective action of nonconforming product.
3.5Customer Support is responsible to coordinate customer notification, if required.
4.0References
4.1Normative References - The following references contain provisions which through reference in this text, constitute provisions of the procedure. References which are subject to revision shall always be used in the most recent form.
QM 9.0 – Nonconformance
QM 5.0 – Control of Quality Records
QSP 8.3 – final Inspection for Producer
QSP 10.1 – Corrective and Preventive Action
4.2Documentation/Records – The implementation of this procedure may require the use of the below listed forms and/or systems.
QCS – Quality Control System
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