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Quality Manual
BQ-9000 Producer
Quality System
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Greenleaf Biofuels LLC
100 Waterfront Street
New Haven, CT 06512
Effective Date August 15th, 2014
Table-of-Contents
1.0 SCOPE 3
2.0 ACRONYMS, TERMS, AND DEFINITIONS 3
3.0 REFERENCES 5
3.1 Normative References 5
3.2 Informative References 5
4.0 DOCUMENTS 6
4.1 Quality Manual 6
4.2 Quality Policy 6
4.3 Quality System Procedures 6
4.4 Document Control 7
4.5 Control and Retention of Records 7
5.0 MANAGEMENT RESPONSBILITY 7
5.1 Quality Management Representative 7
5.2 Internal Quality System Audit 8
5.3 Quality Management Review 8
6.0 BIODIESEL PRODUCTION 9
6.1 Process Changes 9
6.2 Production Lots 9
7.0 SAMPLING and TESTING under BQ-9000 Producer Certification 10
7.1 Sampling 10
7.2 Testing Production Lots 10
7.3 Testing EN14214 Alternative 11
7.4 Commingling of Production Lots 11
7.5 Production Lot Tank Homogeneity 11
7.6 Certification of Analysis (COA) 12
7.7 B100 Storage Tank Inactivity 12
7.8 B99 Fuel Blending 12
8.0 LABORATORIES 13
8.1 Laboratories 13
8.2 Laboratory Auditing Protocol 14
8.2.1 Internal laboratories 14
8.2.2 External laboratories 14
9.0 Trucks, Railcars, and Vessels Containing Biodiesel 14
9.1 Loadout Cleanliness Controls 14
10.0 Nonconformance, Corrective Action, Préventive Action 14
10.1 Nonconforming Product 14
10.2 Corrective and Preventive Action Procedures 15
Appendix A: Organization Chart 16
1.0 SCOPE
Greenleaf Biofuels LLC is located at 100 Waterfront Street, New Haven, CT 06512. Greenleaf Biofuels is a limited liability company formed in 2004 to bring renewable energy alternatives to Americans who value preserving our natural environment and strengthening our energy security. The Company was one of the first wholesale and retail distributors of biodiesel in New England, and is operating a regional biodiesel manufacturing facility in New Haven, CT, within the largest tank farm port between New York and Boston. Greenleaf Biofuels LLC is 100% using waste oil to produce biodiesel, including reclaimed vegetable oil, waste vegetable oil (yellow grease), and animal fats. Biodiesel (B100) is produced and qualified to the ASTM D6751 specification.
Greenleaf Biofuels knowingly meets all applicable state and federal guidelines for the production of biodiesel. Greenleaf Biofuels is an equal opportunity employer and operates in a safe and efficient manner.
Greenleaf Biofuels addresses quality assurance through application of the current BQ-9000 Producer Standards, which has been established by the National Biodiesel Board (NBB) and the National Biodiesel Accreditation Commission (NBAC). This includes the use of corrective actions to prevent nonconformity.
Reference Document(s)
Appendix A, Greenleaf Biofuels Organization Chart
2.0 ACRONYMS, TERMS, AND DEFINITIONS
For use in the Quality Manual, the following terms and definitions apply. Additional terms and definitions are referenced in the Quality System Procedures, Standard Operating Procedures, Standard Assay Procedures, and Forms as appropriate. This list is not all-inclusive.
2.1 ASTM: ASTM International, originally known as the American Society for Testing and Materials (ASTM), was formed over a century ago. ASTM International is one of the largest organizations in the world for the development of voluntary standards. ASTM develops technical standards for materials, products, systems, and services.
2.2 Biodiesel: A fuel comprised of mono-alkyl esters of long-chain fatty acids derived from vegetable oils or animal fats and meeting ASTM D 6751, designated B100.
2.3 Blend: A blend of biodiesel with petroleum-based diesel fuel in a specified ratio designated Bxx, where xx is the volume percent of biodiesel.
2.4 Document Control: The processes involved with issuing, monitoring, and controlling the QM, QSPs, SOPs, WIs, Records, Forms.
2.5 External Laboratory: A third-party laboratory that the biodiesel organization can use to test product samples.
2.6 Feedstock: Fats or Oils used as the raw materials in the production of biodiesel.
2.7 Internal Laboratory: A laboratory that is operated or managed by the Greenleaf Biofuels.
2.8 Marketer: An entity engaged in the business of the distribution and sale of biodiesel and/or biodiesel blends of B2 or greater.
2.9 NBAC: The National Biodiesel Accreditation Commission is an autonomous committee of the National Biodiesel Board that oversees and directs the BQ-9000 program.
2.10 Organization: A producer or marketer of biodiesel or biodiesel blends.
2.11 Producer: An organization involved in the production of B100 through assets under their direct control. Producers can either sell B100 or biodiesel blends of B99 or greater. The producer must be registered with the EPA as a renewable fuels producer.
2.12 Production Lot: A biodiesel production lot consists of a homogeneous production volume of finished biodiesel derived from one or more sources. The product is held in a single container where representative samples are taken and then analyzed to complete an authentic Certificate of Analysis (COA) for that specific volume.
2.13 Quality Manual (QM): A document that describes the elements of the quality program used to assure that the requirements of BQ-9000 program are met.
2.14 Quality Program: The organizational structure, roles, responsibilities, procedures, processes, and resources necessary to manage quality.
2.15 Verification: Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.
2.16 COA: Certificate of Analysis
2.17 FO: Form
2.18 MSDS: Material Safety Data Sheet
2.19 NBAC: National Biodiesel Accreditation Commission
2.20 NBB: National Biodiesel Board
2.21 REC: Record
2.22 QCS: Online Quality Compliance System for management of Quality Records
2.23 QM: Quality Manual
2.24 QSP: Quality System Procedures
2.25 WI: Work Instruction
3.0 REFERENCES
3.1 Normative References
Greenleaf Biofuels uses the following ASTM references in the production of biodiesel. These documents are subject to revision. External document control requirements, as described in section 4.4 of this Quality Manual, stipulates that the most recent version of any reference document is to be followed.
ASTM D1298, Standard Test Method for Density, Relative Density (Specific Gravity), or API Gravity of Crude Petroleum and Liquid Petroleum Products by Hydrometer Method.
ASTM D4057, Standard Practice for Manual Sampling of Petroleum and Petroleum Products.
ASTM D4176, Standard Test Method for Free Water and Particulate Contamination in Distillate Fuels (Visual Inspection Procedures)
ASTM D6751, Standard Specification for Biodiesel Fuel Blend Stock (B100) for Distillate Fuels.[1]
ASTM D7467, Standard Specification for diesel fuel oil, Biodiesel Blend (B6-B20)
Form BQF-1 BQ-9000 External Laboratory Verification
3.2 Informative References
These references are included as bibliographic information because they contain material that may be useful in the application of the BQ-9000 Producer requirements. Greenleaf Biofuels has used excerpts from the following references to develop the requirements for this document:
ISO 9001:1994 Quality Management Systems – requirements2
BQ-9000 Producer Revision 8, January 20th, 2014
ISO 9001: 2008 Quality Management Systems
ISO 19011:2002 Guidelines for quality and/or environmental management system auditing
4.0 DOCUMENTS
Greenleaf Biofuels will implement the newest revision of the BQ-9000 Producer Program Requirements into their quality management system within 90 days of the effective date of the latest revision. The organization will notify the NBAC when these quality system changes have been made.
4.1 Quality Manual
Greenleaf Biofuels Quality Program is documented in this Quality Manual, which meets the requirements of the current BQ-9000 Producer Standard. Included in this Quality Manual are the means to ensure that B100 conforms to ASTM D6751. This Quality Manual references applicable Quality System Procedures
Reference Document(s)
QSP 4.1: Document Control
4.2 Quality Policy
Greenleaf Biofuels management and employees are committed to providing high quality biodiesel services to our customers, achieving continuous quality improvement, and operating a company that is safety-conscious and environmentally aware.
Objectives:
1. Safety, Health and Environment
Objective: Zero lost time due to accidents and regulatory Notices of Violations (NOV) and 100% safety training completion.
Measurement:Incident Records, Environmental Compliance Records, and Employee Training Records.
2. Customer Satisfaction
Objective:100% customer satisfaction of quality, performance and delivery of biodiesel product.
Measurement:Customer Satisfaction Records.
3. Overall throughput
Objective: achieve 75% of designed production capacity in 2014 (June to December) and achieve 100% of designed production capacity in 2015.
Measurement: measured by volume of final product.
4. Production Efficiency
Objectives: a. 90% of reliability (reactors, decanters and dyers);
b. 90% of single polishing batches (polisher);
c. 95% yield.
Measurements: a. reliability;
b. single polishing percentage;
c. Total yield.
Greenleaf Biofuels Quality Policy and Quality Objectives are communicated to employees to involve them in the BQ 9000 system by posters and at meetings.
4.3 Quality System Procedures
Greenleaf Biofuels Quality Manual references information that is documented in Quality System Procedures (QSP). The QSP’s describe the processes used to determine and document how both Operational Quality requirements and BQ-9000 Producer requirements will be met.
Greenleaf Biofuels Quality System Procedures make reference to work instructions that exist in written form, flow charts, pictures, or video clips and define how an activity will be performed. Forms or records that are required by the BQ-9000 Producer Standard are referenced in the QSP’s.
Reference Document(s)
QSP 01.1: Management Review Meeting
QSP 02.1: Quality Management Representative
QSP 03.1: Internal Quality Audit
QSP 04.1: Document Control
QSP 05.1: Record Control
QSP 06.1: Process Control
QSP 07.1: Identification and Traceability
QSP 08.1: Inspection and Testing
QSP 09.1: Control of Nonconformance
QSP 10.1: Corrective and Preventive Action
4.4 Document Control
Greenleaf Biofuel’s Quality Program contains provisions for maintaining and controlling documents related to the BQ-9000 Quality Program. Documents will be identified by an assigned unique alpha-number, revision code, and effective-date. Obsolete and superseded documents are marked as such and archived to prevent unintended use.
Greenleaf Biofuels maintains and distributes the active and archived controlled documents (e.g. QM, QSP’s, work instructions, and forms) within the QCS Quality Compliance System (QCS). This online system provides the formal “view” distribution of documents and the historical list of archived documents, with reason-for-revision.
Reference Document(s)
QSP 4.1: Document Control
QCS: Quality Compliance System
4.5 Control and Retention of Records
Greenleaf Biofuels records for the BQ-9000 Quality Management Program are established and maintained to provide evidence of effective implementation and operation of the system, as well as conformity with all requirements. Quality records are controlled and retained electronically online or physically on revision controlled forms. Both methods include a date to timestamp information, and determine appropriate retention.
Necessary records mandated by the BQ-9000 requirements are retained for a minimum of two (2) years unless otherwise indicated. Necessary records for the BQ-9000 requirements are legible, identifiable, and accessible in the work areas where they are used or referenced, and are stored in a manner that ensures integrity.
Reference Document(s)
QSP 05.1: Record Control
QCS: Quality Compliance System
5.0 MANAGEMENT RESPONSBILITY
5.1 Quality Management Representative
Greenleaf Biofuels Quality Management Representative (QMR) is a Biodiesel Specialist. In the event that the Biodiesel Specialist is unable to perform the duties of the QMR, the company President will appoint a qualified person in his/her place. In addition to normal job responsibilities, the QMR will be required to:
· Chair Quality Management Review meetings.
· Ensure that a Quality Program meeting BQ-9000 requirements is established.
· Report on the performance of the Quality Program.
· Ensure that the most recent version of each quality document is made available to management and employees.
Reference Document(s):
QSP 02.1: Quality Management Representative
5.2 Internal Quality System Audit
Greenleaf Biofuels has developed and implemented a system for performing Internal Quality Audits. Internal Quality Audits for each element of the Quality Program will be performed, at a minimum, once per year to verify that Greenleaf Biofuels operations comply with the requirements stated in its Quality Management Program and to determine the Quality Program’s effectiveness.
The audit frequency will be increased when internal or external audit results indicate that increased frequency would be beneficial, or whenever a need is determined by the QMR and/or the management of Greenleaf Biofuels Internal or external audit results will be presented to the management personnel responsible for the area, who will then identify opportunities for improvement and/or corrective or preventive actions to address nonconformities. Nonconformities will be resolved in a timely manner as stated in the applicable documented procedures. The Internal and External Audit Report, Nonconforming Reports, and Corrective and Preventive Action Reports will be filed appropriately as records for 2 years.
Reference Document(s)
QSP 03.1: Internal Quality Audits
QSP 04.1: Document Control
QSP 05.1: Control of Forms or Records
QSP 09.1: Control of Nonconformance
QSP 10.1: Corrective and Preventive Action
5.3 Quality Management Review
Greenleaf Biofuels holds Quality Management Review meetings at least once every six months as determined by the QMR or upper management. Additional meetings will be held if necessary. Input for management review meetings will be obtained from the following information:
a) Results of Internal Quality Audits
b) Customer feedback
c) Process performance & product conformity
d) Status of preventive and corrective actions
e) Follow-up actions from previous management reviews
f) Changes that could affect the Quality Management Program
g) Recommendations for improvement
Record of the Quality Management Review meetings will be kept for two (2) years.
Reference Document(s):
QSP 01.1: Management Review Meetings
QSP 03.1: Internal Quality Audit
QSS 09.1: Control of Nonconformance
QSP 10.1: Corrective and Preventive Action
6.0 BIODIESEL PRODUCTION
6.1 Process Changes
A significant process change is one that could materially alter the composition of the product. Greenleaf Biofuels will review process changes and determining whether the change is considered significant. Records are kept of significant process changes.
The following are examples of what could be considered a significant process change:
a) the use of different raw materials,
b) the use of new or modified equipment,
c) refurbishment of existing equipment,
d) change in equipment location,
e) Use of equipment that has been inactive for volume production for 30 days or more.