Quality System Procedure
09.1 Control of Nonconformance
rev-09a00 - Approved by: Stephen Martin I
1.0 Purpose and Scope
The purpose of this procedure is to establish a process to ensure that nonconforming biodiesel that is used to fill required customer contract(s) for BQ-9000 is prevented from unattended use. This procedure will apply to incoming and outgoing B100 biodiesel product or blends at Martin Eagle Oil Company, Inc. that are under contract or agreement to be delivered to or from a BQ-9000 producer or marketer.
This procedure also establishes the method to report, disposition, and respond to suspected process nonconformance (e.g. work instructions) and equipment (e.g. lab equipment). This applies to biodiesel related operations.
1.1 Definitions
Nonconformity: Product, material, or process that does not meet specifications required by the BQ-9000 standard or ASTM D 6751.
CAT: Corrective Action Team which reviews and dispositions suspected nonconforming processes.
Customer Complaint: A nonconformity that is discovered by the customer and reported to Martin Eagle Oil Company, Inc. Oil.
Disposition of Nonconformity: Action to be taken in regard to an existing activity, process, product, material, organization or any combination thereof in order to resolve a nonconformity.
Accept: Accept as-is, analysis has determined no nonconformance.
Rework: A nonconformance disposition whereby a nonconforming product or equipment is made to conform to a required specified requirement by completion, reprocessing, or other corrective means.
Reclassify: Reclassify product or equipment for another application.
Scrap: Product or equipment cannot be reworked, and must be isolated
Products: B100 or Biodiesel blends
Nonconformity Report (NCR): reporting method to be used for the reporting of nonconformities.
MRB: Material Review Board which reviews and dispositions suspected nonconforming products.
2.0 Procedure
2.1 Nonconforming Product or Equipment
In the event a suspected nonconforming condition relating to product or equipment 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.
2.1.1 MRB Team 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 who have knowledge of the problem and/or the resolution.
2.1.2 Nonconformance Identification
· Anyone who detects a suspected nonconforming condition shall be responsible for properly identifying that condition by initiating Nonconformance Case.
· When product or equipment 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
· The nonconformance case is forwarded to the MRB for review and disposition
2.1.3 Nonconformance Disposition
· The MRB is responsible to review the problem and determine required actions.
· There are four types of dispositions applicable:
o Accept
o Rework
o Re-classify (to another application)
o Scrap
2.1.4 Nonconformance Actions
· One or more Corrective and Corrective actions can be can be initiated to resolve immediate problem, identify root cause, and prevent reoccurrence of non-conformance (see QSP 10.1)
· The disposition of “rework” shall be accompanied by rework instructions, completed by the MRB. Reworked product or equipment shall be re-inspected in accordance with the standard inspection procedures (QSP_08.1).
· The MRB is responsible for appropriately distributing case findings, initiating appropriate action and retaining nonconformance case records.
· Customer Support shall be involved with nonconformance cases involving delivered products. Corrective action requires notification of customer and possible recall or other actions.
· If the disposition of nonconforming product renders it different from customer specification, customer notification may be required. Customer Support shall notify the appropriate customer contact.
2.2 Nonconforming Process
In the event a suspected nonconforming condition relating to a process is detected, a nonconformance case shall be documented and submitted to the Corrective Action Team (CAT) for disposition. The CAT has full authority to make decisions for their respective organizations. The CAT also has the responsibility for requesting Corrective Action (QSP_10.1) when applicable.
2.2.1 CAT Team Assignments
· The board consists of a Quality chairman, permanent members with authority from key functional areas (e.g. quality, operations), and temporary members. For each case, the permanent CAT can assignee temporary team members which have knowledge of the problem and/or the resolution.
2.2.2 Nonconformance Identification
· Anyone who detects a suspected nonconforming condition shall be responsible for properly identifying that condition by initiating Nonconformance Case.
· The nonconformance case is forwarded to the CAT for review and disposition.
2.2.3 Nonconformance Disposition
· The CAT is responsible to review the problem and determine required actions.
· There are three types of dispositions applicable:
o Accept
o Rework
o Scrap
2.2.4 Nonconformance Actions
· The CAT provides instructions for corrective actions, if required. (see QSP 10.1)
· The CAT is responsible to distribute findings, initiate appropriate action and retain nonconformance case records.
· Affected functional areas are involved with problem analysis, disposition, and corrective actions (if required).
3.0 Responsibilities
3.1 Employees, transport drivers, or contract employees of Martin Eagle Oil Company, Inc. are responsible for communicating suspicion or confirmation of nonconformance, as defined by BQ-9000 Marketer Standard or ASTM D 6751. Nonconformance may be identified through testing or visual inspection at any time from receiving through production, to storage and loading out of B100 or Biodiesel blend fuel.
3.2 The MRB is responsible to review and authorized to “sign-off” on the disposition of nonconforming product.
3.3 The CAT is responsible to review and authorized to “sign-off” on the disposition of nonconforming process.
4.0 References
QSP 08.1 Inspection and Testing
QSP 10.1 Corrective and Preventive Actions
WI 10-10-0001 QCS - Access to Online Quality Control System
WI 10-10-0901 QCS - Nonconforming Product
WI 10-10-1001 QCS - Corrective & Preventive Action Process
Figure_10-88-0901 – Nonconforming Product Flowchart
System QCS – Quality Compliance System
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