Delta Biofuels, Inc Quality Manual Overview. QM_r01 / 26 Mar 07

Transcription

1 Delta Biofuels, Inc Quality Manual Overview QM_r01 / 26 Mar _r UNCONTROLLED IF PRINTED

2 Quality Manual for Delta Biofuels, Inc SCOPE The Quality Management System (QMS) policies contained in this Quality Manual apply to the Delta Biofuels, Inc. This operation has its facility at 151 L E Barry Rd, Natchez, MS Delta Biofuels, Inc, is engaged in the business of manufacturing and selling Biodiesel which meets ASTM D 6751, Standard Specification for Biodiesel Fuel (B100) Blend Stock for Distillate Fuels and Biodiesel Blends. Delta Biofuels, Inc is comprised of a single manufacturing plant which also houses all the divisional administrative functions. The Quality Manual (QM) is divided into 10 sections (elements) corresponding to the quality system requirements of BQ Each section starts with a purpose and scope statement expressing the commitment to implement the basic principles of the quality system element that is the subject of the section. Table of Contents - Quality System Policies Designation Title 1.0 Management Responsibility 2.0 Quality System 3.0 Internal Quality Audits 4.0 Document and Data Control 5.0 Control of Quality Records 6.0 Process Control 7.0 ID and Traceability 8.0 Inspection and Testing 9.0 Nonconforming Product 10.0 Corrective and Preventive Action The policy establishes an outline for more specific procedures which are numbered by section in a corresponding manner and contained in separate manual, the Quality System Procedures (QSP) manual. The documents contained in the two manuals (QM and QSP) together define and describe the Quality Management System at Delta Biofuels, Inc, the authorities and responsibilities of the management personnel affected by the system, and provide general procedures for all activities comprising the quality system. The manuals also provide a presentation of the Quality Management System to Delta Biofuels, Inc customers and serves to inform them of the specific controls implemented to assure product quality. 0.0_r UNCONTROLLED IF PRINTED page 2 of 3

3 CONTROLLED DOCUMENT - electronic distribution The Quality Manual (QM) is composed of the set of company policies. Each policy is a controlled document. The control is both revision level number and date. Delta Biofuels, Inc controls and distributes the Policies electronically. The master policies reside online. Any printed copies of documents shall be considered uncontrolled and should be marked as such for added clarity. Quality Policies 0.0_r UNCONTROLLED IF PRINTED page 3 of 3

4 1.0 Management Responsibility Rev 01 / date 03/20/07 - Approved by: Clint Vegas / Scott Nisula The purpose of the Management Responsibility policy is to define the quality policy; responsibility, authority, and interrelation of personnel who manage, perform, and verify work affecting quality; establish a periodic management review of the quality system; and describe the analysis and use of company data relating to quality and operational performance. The policy applies to Delta Biofuels, Inc and the BQ-9000 program requirements. 2.0 Policy 2.1 Quality Policy - The quality policy of Delta Biofuels, Inc has been developed with input from the work force. This process of formulation has resulted in the policy being relevant to the personnel who manage, perform, and verify work affecting quality. The quality policy of Delta Biofuels, Inc is: Delta Biofuels will utilize our Quality Assurance Policies, Procedures and Work Instructions to ensure that products delivered to our customers meet or exceed their requirements. We will continuously strive to improve our processes, with active programs to measure our continued success. Delta Biofuels' Mission is to be the industry preferred supplier of biodiesel products, because our product quality and delivery reliability are recognized as best in class. 2.2 Management Representative - A quality management representative (QMR) has been appointed and irrespective of other duties, shall chair quality management review meetings, ensure that a quality program is established and that it meets the requirements herein, report on the performance of the quality program and ensure that the most recent version of the quality manual is made available to personnel. 2.3 Organization - A description of the management organization indicating functional areas with specific listings of quality system responsibilities and signatory authority are shown in Appendix A. Each quality system policy or procedure shall include a section listing responsibilities. Further, each area of responsibility should provide for signatory reassignment in the event of the designee s absence from the workplace. 2.4 Quality Management Review - Management shall review the quality system (including all elements) at defined intervals sufficient to ensure its suitability and effectiveness in satisfying the requirements of the QM policies and the company quality policy (see 2.1) and those policies of the QM are in compliance with the requirements of BQ Records of such reviews shall be maintained. 2.5 Analysis and Use of Company-Level Data - Functional Areas shall document trends in product quality, process performance and current quality levels for key product features and compare trends with appropriate goals. Trends in data and information shall be compared with progress toward overall business objectives and translated into actionable information to support the development of priorities for continuous improvement. 1.0_r UNCONTROLLED IF PRINTED page 1 of 3

5 3.0 Responsibilities Quality System Policy 1.0 Management Responsibility Rev 01 / date 03/20/07 - Approved by: Clint Vegas / Scott Nisula 3.1 Executive Management shall be responsible for ensuring that the quality policy (see 2.1) is understood, implemented, and maintained at all levels of the organization and ensure review of trends in customer satisfaction concerning product quality, analysis and use of company-level data, and review of the quality system. 3.2 Executive Sponsor shall appoint a QMR having responsibility and authority as stated in Management Review Team shall establish a procedure for documenting trends in quality, operational performance, and current quality levels for key product attributes. 4.0 References 4.1 Normative Reference - The following references contain provisions which, through reference herein, constitute provisions of this policy. References which are subject to revision shall always be used in the most recent form. BQ-9000 Quality Management System - Accredited Producer Requirements BQ-9000 Quality Management System - Certified Marketer Requirements 1.0_r UNCONTROLLED IF PRINTED page 2 of 3

6 1.0 Management Responsibility Rev 01 / date 03/20/07 - Approved by: Clint Vegas / Scott Nisula Appendix A Quality System Responsibilities ( normative ) Executive Sponsor (1,2) QMR (1,2,3,5) Operations (1,2,4,5,6,7,8,9,10) Raw Material Supply (1,2,4,5,7,10) Maintenance (8,10) Inventory Control (1,2,4,5,6,7,10) Quality (1,2,4,5,6,7,8,9,10) Chemistry Lab (8) Sales (1,2,4,5,10) Customer Support (1,2,4,7,9,10) Shipping / Receiving (5,6) Document Control (4) Figure Note-01: Quality System responsibilities are defined to support the areas of key quality control. In smaller companies, these roles may differ from actual organization where individuals typically have multiple responsibilities. Note-02: The numbers in parenthesis in each functional area indicate a direct responsibility for a like numbered quality system element as follows: 1. Management Responsibility 6. Process Control 2. Quality System 7. ID & Traceability 3. Internal Audits 8. Inspection and Testing 4. Document & Data Control 9. Nonconforming Product 5. Control of Quality Records 10. Corrective and Preventive Action 1.0_r UNCONTROLLED IF PRINTED page 3 of 3

7 2.0 Quality System Rev-00 / date 01/16/07 Approved by: Wanda Horne The purpose of this policy is to establish a documented quality management system designed and implemented to fulfill BQ-9000 program requirements. The quality system is documented in the policies in this Quality Manual (QM) and supported by Quality System Procedures (QSP) and Work Instructions which support the procedures. The purpose of the quality system is to ensure that biodiesel operations are planned and performed using defined and controlled methods. It applies to all Delta Biofuels, Inc biodiesel operations. 2.0 Policy 2.1 Documentation - The quality system is defined in the company s policies, procedures, and work instructions. These documents collectively define a quality system that complies with the BQ-9000 program requirements Policies ( Goals ) Policies define level-1 of the Quality System, the company s quality goals. These documents collectively define the Quality Manual (QM) Procedures ( What ) Procedures define level-2 of the Quality System, what our company does to satisfy the level-1 policies. Procedures are written to define the business requirements. These documents collectively define the Quality System Procedures (QSPs) Work Instruction ( How ) Work Instructions define level-3 of the Quality System, the how to details which support the procedures. Work Instructions provide the auditable step-by-step details of how tasks are consistently done. Work Instruction are written to support a) Cross-Functional Business Flows, where responsibility is share by multiple areas b) Individual Functional Areas (e.g. shipping, receiving, operations, quality assurance) where responsibility is within a single area. c) Operational usage of equipment. Where multiple methods and equipment exist to perform a similar process, separate work instructions are created to document the step-by-step details. (e.g. sampling instructions may differ by tank design, unloading instructions differ if truck or railcar) Also within the level-3 detail documents are any supporting forms and specifications. 2.2 Implementation - All personnel who delegate, manage, perform, and verify work affecting quality are responsible for implementing the quality system. Procedures are written to provide guidance in executing, coordinating, monitoring, and auditing the system. Implementation of the quality system is assessed regularly by way of internal and external audits and management reviews. 2.0_r UNCONTROLLED IF PRINTED page 1 of 2

8 2.0 Quality System Rev-00 / date 01/16/07 Approved by: Wanda Horne 2.3 Planning - Quality Planning is developed and defined in written procedures to describe the process to be employed for determining and documenting how operational quality requirements are to be met. The quality planning process may include the development of product specific control plans. Control plan development shall include input from a cross-functional group. 3.0 Responsibilities 3.1 All Primary Functional Areas (i.e. Purchasing, Customer Support, Operations, Quality, ) shall be responsible for ensuring that the quality management system is understood, implemented, and maintained at appropriate levels of the organization and used to effectively operate the company s biodiesel operations. 3.2 The Quality Management Representative shall ensure that the quality management system is maintained, is continuously improved and updated, and that the system always complies with the requirements of BQ References 4.1 Normative References - The following references contain provisions which, through reference herein, constitute provisions of this policy. References which are subject to revision shall always be used in the most recent form. BQ-9000 Quality Management System - Accredited Producer Requirements BQ-9000 Quality Management System - Certified Marketer Requirements 2.0_r UNCONTROLLED IF PRINTED page 2 of 2

9 3.0 Internal Quality Audits Rev 00 / date Approved by: Wanda Horne The purpose of this policy is to establish and maintain documented procedures for planning and implementing internal quality audits to verify whether quality activities are effective in producing the required results, and to determine the overall effectiveness of the quality system. It applies to all Delta Biofuels, Inc biodiesel related operations. 2.0 Policy 2.1 Internal quality audits shall be performed and recorded in accordance with documented procedures. 2.2 Every element of the Quality System shall be audited at least once a year. Selected elements may be audited more frequently, depending on their importance and quality performance as determined by the Management Review Team or the Corrective Action Team. 2.3 Only trained personnel independent of the audited elements are assigned to conduct internal audits. 2.4 Nonconformances and Corrective Action Plans shall be recorded in accordance with documented procedures. 2.5 When nonconforming conditions are identified, the manager responsible for the area is accountable for implementation of corrective action. Implementation and effectiveness of the action shall be verified and recorded by a follow-up audit according to procedures. 2.6 Internal quality audit results will be made available to the Management Review Team. 3.0 Responsibility 3.1 The QMR will be responsible for the administration of this policy. 4.0 References 4.1 Informative References - The following references are included as bibliographic information which may contain material useful in the execution of this policy. ISO , Guidelines for auditing quality systems - Part 1: Auditing. ISO , Guidelines for auditing quality systems - Part 2: Qualification criteria for quality systems auditors. ISO , Guidelines for auditing quality systems - Part 3: Management of audit programs. 3.0_r UNCONTROLLED IF PRINTED page 1 of 1

10 4.0 Document and Data Control rev-01 / date 03/26/07 - Approved by: Wanda Horne The purpose of this policy is to establish the requirements for the systematic control of all BQ quality program related documents and data. Documents may also take the form of electronic media or computer programs which shall likewise be subject to the controls set forth in this policy. This applies to all Delta Biofuels, Inc biodiesel related operations. 2.0 Policy 2.1 Hierarchy A hierarchy of documentation exists in the following order: 1. International or national standard body standards and technical organization standards (i.e. ASTM) 2. Quality Manual / Policies 3. Quality System Procedures 4. Work Instructions 2.2 Quality System Documents Quality system documents including policies, procedures, and work instructions shall be structured and subject to approval, revision, and distribution controls Control The policies, procedures and work instructions shall be controlled documents. The control is both revision level number and date. The Document Control group shall control and distribute the company s policies, procedures, and work instructions electronically. The Active and archived versions of the documents shall be available online Format Policies and procedures shall be universally formatted with page headings as shown herein. The formatting consistency is maintained by Document Control. Work of instructions may be formatted with page headings similar to policies and procedures. The formatting consistency is maintained by Document Control Approval and Review Changes to documents shall be reviewed and approved by the same functions that performed the original review and approval, unless specifically designated otherwise. Each policy will bear the approval signature of the executive manager with direct functional responsibility for the area to which the policy primarily pertains according to the matrix in Table 1. Each procedure will bear the approval signature of the staff member with primary direct functional responsibility for executing the procedure. Each work instruction will bear the approval signature of the responsible department head(s). 4.0_r UNCONTROLLED IF PRINTED page 1 of 8

11 4.0 Document and Data Control rev-01 / date 03/26/07 - Approved by: Wanda Horne Distribution Documents and data shall be reviewed and approved for adequacy by authorized personnel prior to issue. A document control procedure shall be established and be readily available to ensure the use of only valid and/or current documents. The control shall ensure that the pertinent issues of appropriate documents are available at appropriate locations and that obsolete documents retained for legal and/or knowledge preservation purposes are suitably identified Printed copies Any printed copies of documents shall be considered uncontrolled and should be marked as such for added clarity Sustaining Reviews Each policy and procedure shall be subject to a review every three years by the preparer of the document. A reviewed document with no proposed changes by the preparer will nonetheless be considered a revision for review. Managing reviews is the responsibility of Document Control Request for Change Policies and procedures may be revised prior to the three-year review date upon submission of a Corrective and Preventive Action. The requestor shall state the reason for the change and may suggest revised wording. Such requests shall be forwarded to the document preparer and begin the process of revision and review. 2.3 Editorial Details Wording of Purpose and Scope Statement This element shall be worded as a series of statements of fact. Forms of expression such as "This policy establishes..." or "The purpose of this policy is to specify the requirements for..." are to be used. The concluding sentence describes the scope in terms of where or to what the policy applies. An example of a scope statement is "This policy applies to all Delta Biofuels, Inc biodiesel operations" Verbal Forms of Expression The word "shall" is to be used to indicate requirements strictly to be followed. Equivalent expressions are "is to...", "is required to...", "has to...", or "it is required that...". "Shall not" is the antonym form. Do not use "may not" instead of "shall not". In making a recommendation or stating a preferred method use the word "should", equivalents being "it is recommended that..." or "ought to...". To indicate a course of action permissible within the limits of the document, use the word may (for the opposite use "need not"). Equivalent expressions for "may" are "is permitted", "is allowed", or "is permissible". Do not use "can" instead of "may". To indicate statements of possibility, use "can" or equivalent forms "to be able to...", "to be in a position to...", "there is a possibility of...", or "it is possible to...". Note that "may" signifies permission expressed by a document, whereas "can" refers to the ability of a user or to a possibility open to a user. 4.0_r UNCONTROLLED IF PRINTED page 2 of 8

12 4.0 Document and Data Control rev-01 / date 03/26/07 - Approved by: Wanda Horne 2.4 Quality Manual (QM) The QM shall be a set of policies, electronically distributed in their most current form. Included will be a minimum number of policies to address the elements of BQ Policy Numbering The policies shall be numbered to correspond with numerical element assignments and include revision identification. This number shall be included on the lower left corner of each page. Format: e.0_rxx yymmdd, where, e.0 = element number (see below) rxx = major revision number, identifying technical change yymmdd = minor revision date(year,month,day), identifying non-technical clerical change examples 4.0_r , 10.0_r Element Numbers 1.0 Management Responsibility 2.0 Quality System 3.0 Internal Quality Audits 4.0 Document and Data Control 5.0 Control of Quality Records 6.0 Process Control 7.0 ID and Traceability 8.0 Inspection and Testing 9.0 Nonconformance Product 10.0 Corrective and Preventive Action Structure Each policy will have a minimum of three sections numbered and titled: 2.0 Policy 3.0 Responsibilities Sub-clause Numbering An optional sub-section for definitions (numbered 1.1) may be included. If a section has more than one substantive point, it shall be divided into sub-sections 2.1, 2.2, 2.3, etc. The Responsibilities section may include a sub-clause for each functional area (or department) with responsibility to execute a policy or provide an interrelationship with another area Normative References References which are required for the proper execution of the policy and thus form an integral part of the policy are listed within section 4.1 Normative References. References should always be used in the most current form. Normative references shall be made only at an equal or higher level in the hierarchy order Informative References Non-normative references which may contain material which is helpful to the execution of this policy are listed within section 4.2 Informative References Current Reference Revision References which are subject to revision should always be used in the most recent form. 4.0_r UNCONTROLLED IF PRINTED page 3 of 8

13 4.0 Document and Data Control rev-01 / date 03/26/07 - Approved by: Wanda Horne 2.5 Quality System Procedures (QSP) There shall be procedures written to support the requirements set forth in the Quality Manual (QM). As a minimum, the number of procedures shall be sufficient to adequately clarify the intent of each policy. The procedures shall be separate from the QM, electronically distributed in their most current form, and designated as Quality System Procedures (QSP). Procedures are not required when the policy execution is evident Numbering Each procedure shall be numbered to correspond to the policy being supported in an nn.nn format. The numeral(s) to the left of the decimal point shall be the policy number being supported and the numeral(s) to the right of the decimal shall be sequential beginning with 01. A procedure can not be numbered x.0 because this represents a policy number. This number shall be included on the lower left corner of each page. Format: e.n_rxx yymmdd, where, e = element number / policy supported.n = procedure sequences number ( 1 or greater) rxx = major revision number, identifying technical change yymmdd = minor revision date(year,month,day), identifying non-technical clerical change examples 4.1_r , 10.1_r Structure Each procedure will have a minimum of three sections numbered and titled 2.0 Procedure 3.0 Responsibilities 4.0_r UNCONTROLLED IF PRINTED page 4 of 8

14 4.0 Document and Data Control rev-01 / date 03/26/07 - Approved by: Wanda Horne 2.6 Work Instructions (WI) and other formal documents Work Instructions shall be prepared on a departmental level to support the requirements of procedures and may include one or more work instructions for each procedure for which a department or functional area is listed in the responsibilities section. A functional area may elect to create a WI to do other than support a QSP in order to subject the document to the same system of document control. Work instruction level documents can include other controlled documents such as forms and Standard Operating Procedures (SOPs) Standard Numbering of Work Instructions All work instruction level documents shall use a standard numbering format, except as defined within External Documents and Non-Standard Numbering. This number shall be included on the lower left corner of each page. Format: xxx.aa.bbccc r00 yymmdd, where, xxx = Plant Site (e.g. 119 = Natchez Plant Site ) aa = Department bb = applicable manual per codes below ccc = procedure number (001, 002, etc.) r00 = revision number for major technical change (r00, r01, r02, etc.) yymmdd = minor revision date(year,month,day), identifying non-technical clerical change (e.g. spelling) examples QA002 r Department Codes: 20 Operations 25 Utilities 30 Maintenance 35 Laboratory 40 Administration 55 Waste Standard Structure Work Instructions will have a minimum of three sections numbered and titled 2.0 Process 3.0 Responsibilities Standard Numbering of Forms Format: Form aa-bbb Rev ccc (mm/yy) where, aa bbb Rev ccc mmyy = Department code (2 digit) = Unique number (3 digit) = fixed text = Major revision number, identifying technical change (3 digits) = Revision date examples Rev 003 (05/00) 4.0_r UNCONTROLLED IF PRINTED page 5 of 8

15 4.0 Document and Data Control rev-01 / date 03/26/07 - Approved by: Wanda Horne External Documents External documents such as standards ( e.g. ASTM, ANSI, ), regulatory documents (e.g. EPA, OSHA,), customer documents (e.g. specifications) and supplier documents (e.g. configuration drawings, & change) may be included for distribution. These documents shall retain the numbering / identification of originating source (e.g. ASTM D 6751) Non-Standard Numbering Other controlled business documents relating to Delta Biofuels quality process should use standard structure where applicable, but variations are acceptable to simply use and adapt to business area requirements. Alternate numbering and structures of documents relating to Delta Biofuels quality program must be approved by QMR prior to use Multi-Department WIs may be written such that the instructions contained therein cross departmental boundaries. 2.7 Controlled Data Data records related to the BQ-9000 quality program may include forms, inspection sheets, process flow diagrams, customer feedback, and/or product specifications. These records may be paper or electronic, and retained as defined in written procedures Numbering / Identification Data Record shall be numbered as appropriate for the application Structure The structure of data records is flexible, a format which is best suited for simplicity of use Controls The control shall ensure that the pertinent data records are available at appropriate locations and that obsolete documents retained for legal and/or knowledge preservation purposes are suitably identified. 3.0 Responsibilities 3.1 Document Control shall be responsible for document and data control of policies, procedures and work instructions. 3.2 Each Functional Area is responsible for third level Quality System Documents (i.e. work instructions) and other documents originating in their respective area. 3.3 Customer Support maintains a record of customer communications and documents. 4.0_r UNCONTROLLED IF PRINTED page 6 of 8

16 4.0 Document and Data Control rev-01 / date 03/26/07 - Approved by: Wanda Horne 4.0 References 4.1 Normative References - The following references contain provisions which, through reference herein, constitute provisions of this policy. References which are subject to revision shall always be used in the most recent form. none 4.0_r UNCONTROLLED IF PRINTED page 7 of 8

17 4.0 Document and Data Control rev-01 / date 03/26/07 - Approved by: Wanda Horne Table-1 (normative) Policy approval and Review Matrix revised: 22-Sept-2006 KEY: P - Prepare: Responsible for preparation of the policy. C - Contribute: Contributing responsibility & provides cross-functional review of policy. A - Approval: Approves the policy and is ultimately responsible that the policy is in effect. B - Prepare and Approve Policy No. Policy Title Management Responsibility A P C C C C C C C C EXECUTIVE SPONSOR Q M R Quality Manager Representative Q U A L I T Y O P E R A T I O N S DOCUMENT CONTROL Raw Material Supply MATERIAL inventory, shipping, receiving Functional Area Assignments SALES CUSTOMER SUPPORT HS&E Health & Safety, Environmental Quality System C P A C C C C C C C Internal Quality Audits P A Document and Data Control A C C B C C C C C Control of Quality Records C B C C C C C C Process Control C C B C C C C ID and Traceability C B C C C C C C Inspection and Testing C B C C C Nonconforming Product C B C C C C Corrective and Preventive Action C B C C C C C C 4.0_r UNCONTROLLED IF PRINTED page 8 of 8

18 5.0 Control of Quality Records Rev-00 / date Approved by: Wanda Horne The purpose of this policy is to ensure that quality records are identified, indexed, and stored in a suitable environment to allow for their appropriate preservation. This policy applies to all Delta Biofuels, Inc operations affecting product quality. 2.0 Policy 2.1 General - Quality records demonstrate achievement of required product quality and effective operation of the quality system. Quality records provide the evidence that product in-process meets input requirements, that finished product conforms to output requirements, and that the quality system is operated in accordance with documented procedures and that it is effective. Records are stored in appropriate area, as defined by procedures. Quality records shall be retained for a minimum or 2 years. 2.2 Establishment of Records - Records are usually established by the personnel directly involved with the task, operation, or activity requiring results to be recorded. Results are dated; identify the product, person, or event to which they pertain; provide the relevant facts and data; and identify the function or person who established the record. Specific record formats are usually prescribed by the procedures that call for their establishment. These can be forms, reports, minutes of meetings, sign-offs or stamps placed on other documents, and so forth. Records may be established and maintained in electronic media (computer files or databases). 2.3 Indexing and Storage - Records are indexed and grouped to facilitate their retrieval. Binders, drawers, cabinets, etc., containing records are clearly labeled with identification of their content. Records shall be stored only in defined storage locations. Procedures are written to govern these activities. 2.4 Storage Location and Retention Periods - Records are stored and maintained in an appropriate area, as defined by procedures, and retained for the required period of time. The retention period for records is determined by the department that establishes and maintains the records. The period of retention may be greater than the 2 year minimum BQ-9000 requirement, dependent other requirements such as business, legal and/or regulatory. 2.5 Signatory authority/responsibility - Procedures and work instructions shall specify the approval requirements required for records and documents. Approvals may be written, procedural and/or electronic. When such signatory authority/responsibility is defined, provision for delegating authority must be made in the event of the designee s absence from the workplace. 5.0_r UNCONTROLLED IF PRINTED page 1 of 2

19 3.0 Responsibilities Quality System Policy 5.0 Control of Quality Records Rev-00 / date Approved by: Wanda Horne 3.1 Each Primary Functional Area (i.e. Operations, Quality, ) shall be responsible for ensuring that appropriate procedures and work instructions adequately address the subject of quality records. 3.2 The Quality Management Representative shall ensure that the system of quality records, policies, procedures and work instructions are maintained. 4.0 References none 5.0_r UNCONTROLLED IF PRINTED page 2 of 2

20 6.0 Process Control Rev-00 / date 01/16/07 - Approved by: Paul Patterson This policy establishes the manner in which production processes are planned, documented, controlled, and monitored to manufacture products which comply with established specifications of the BQ-9000 program requirements. It applies to all biodiesel related processes for all Delta Biofuels, Inc operations. 2.0 Policy 2.1 Documented procedures defining the manufacturing processes in the form of work instructions shall be used where the absence of such could adversely affect adherence to product specifications. 2.2 Process controls shall be established, maintained, and monitored to insure control of the production process and product characteristics during the production process. Example: Inspection Sheets 2.3 Approval for changes to existing or introduction of new processes and equipment shall be controlled in compliance with established procedures. 3.0 Responsibilities 3.1 Operations is responsible for defining production processes and is responsible for ensuring that all production personnel are adequately trained, adhering to the process controls and producing product which meets specified quality requirements. 3.2 Management Review Team is responsible for defining and documenting the appropriate controls to ensure product conformance with requirements and that work instructions are established to meet the specified requirements. 4.0 References 4.1 Normative References The following references contain provisions which, through reference herein, constitute provisions of this policy. References which are subject to revision shall always be used in the most recent form. BQ-9000 Quality Management System - Accredited Producer Requirements BQ-9000 Quality Management System - Certified Marketer Requirements 6.0_r UNCONTROLLED IF PRINTED page 1 of 1

21 7.0 Product ID and Traceability Rev-00 / Approved by: Wanda Horne This policy establishes the requirements to ensure that products are properly identified for means of traceability. It applies to all Delta Biofuels, Inc biodiesel related operations. 2.0 Policy 2.1 Documented procedures shall be established and maintained for product identification where applicable, to provide traceability from receipt through the various stages of production and delivery. 3.0 Responsibility 3.1 Operations is responsible for specifying product & lot identification, marking requirements, and inventory control. 3.2 Operations is responsible for maintaining traceable product production records 3.3 QMR is responsible for maintaining the traceability records and reports for product inspection and testing 3.4 Raw Material Supply has visibility of the vendor lot number to each lot of purchased materials that might affect product quality and is able to tie the product receipts to the Purchase Order and the supplier. 3.5 Raw Material Supply shall maintain a vendor folder for each item that contains certifications, lot control numbers and inspection reports for products that might affect product quality. This documentation will be retained for a required period of time. 4.0 References none 7.0_r UNCONTROLLED IF PRINTED page 1 of 1

22 8.0 Inspection and Testing rev-00 / Approved by: Wanda Horne This policy establishes the minimum requirements for inspection, testing and verification activities to ensure that the specified requirements for the product are met. This policy applies to all Delta Biofuels, Inc biodiesel related products. 2.0 Policy 2.1 Receiving Inspection and Testing - Incoming products or materials shall not be used or processed until they have been inspected or otherwise verified as conforming to specified requirements. This is done in accordance with documented procedures and/or work instructions. In determining the amount and nature of inspection, consideration shall be given to the amount of control exercised by the supplier and recorded evidence of that supplier s conformance (e.g. Certificate of Analysis). 2.2 In-Process Inspection and Testing - Procedures and work Instructions shall define the inprocess inspections and inspection points for which production controls are implemented. Process activities are directed toward defect prevention. 2.3 Final Inspection and Testing - No product shall be dispatched until all the inspection and testing activities specified in documented procedures have been satisfactorily completed, and the associated data and documentation are available and authorized. 2.4 Records - All appropriate inspection and testing records shall be maintained according to documented procedures. The records will show whether the product has passed or failed the specified requirements. Records shall identify the inspection authority responsible for the release of the product. 2.5 Laboratory Requirements - Each laboratory ( including outside sources and internal sources) shall be properly equipped with work instructions, calibrated equipment and trained personnel to test according to the appropriate specifications. 3.0 Responsibility Management Review Team is responsible for the administration of this policy. 4.0 References none 8.0_r UNCONTROLLED IF PRINTED page 1 of 1

23 9.0 Control of Nonconformance Rev-00 / Approved by: Wanda Horne The purpose of this policy is to establish the requirements to ensure that product, found to be nonconforming, is prevented from unintended use or shipment. This policy further defines the controls for providing identification, documentation, evaluation, segregation (when practical), and disposition of nonconforming product, and notification to the functions concerned. It applies to all Delta Biofuels, Inc biodiesel related products. 2.0 Policy 2.1 Suspect Nonconforming product is to be promptly identified, isolated (when practical) and subject to review by the Management Review team (MRT). 2.2 Disposition of suspect nonconforming product is to be determined by the Management Review team (MRT). 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 cannot be reworked, and must be isolated & scrapped. 2.3 A prioritized plan for reducing the instances of nonconforming product will be established as nonconformances are investigated and corrective actions are implemented to prevent recurrence (see policy 10.0). 3.0 Responsibilities 3.1 Management Review Team is responsible for disposition of product nonconformances of specified requirements; providing information as required to aid Customer Support; work with Raw Material Supply and suppliers for implementing corrective action of nonconforming purchased product; and responsible for administration of this policy. 3.2 Operations is responsible for implementing corrective action of nonconforming product. 3.3 Customer Support is responsible for any communications with customers regarding nonconforming product. 4.0 References none 9.0_r UNCONTROLLED IF PRINTED page 1 of 1

24 10.0 Corrective and Preventive Actions Rev-00 / Approved by: Wanda Horne This policy establishes the manner in which corrective and preventive actions are initiated, planned, implemented, and audited for effectiveness. This policy applies to all Delta Biofuels, Inc biodiesel operations affecting product quality. 2.0 Policy 2.1 Initiation Any employee may identify corrective and preventive actions. Corrective and Preventive actions shall be initiated as the result of: o Identification of major product nonconformances or a trend of minor nonconformances of a similar character o Problems with processes or work operations o Noncompliance observed during audits o Customer complaints related to product quality o Nonconforming deliveries from suppliers o Identification of any other condition that does not comply with the documented quality management system 2.2 Planning A Corrective Action Team(CAT) shall be assigned to analyze, determine root-cause and recommend corrective actions which are intended to prevent reoccurrence. A corrective action plan shall be reviewed and approved by the Management Review Team(MRT). 2.3 Plan Approval A corrective action plan, shall be approved for implementation by Management Review Team(MRT), with sufficient authority, funds, time, and resources to implement plan. 2.4 Implementation The Corrective Action Team(CAT) implements plan, as approved. 2.5 Follow Up Audit - Every corrective and preventive action shall be s followed up to determine if the implemented actions have been effective, according to procedures. 3.0 Responsibilities 3.1 All Primary Functional Areas (i.e. Operations, Quality, ) shall be responsible for: o Responding to customer complaints regarding product quality o Ensuring that corrective and preventive actions are initiated as appropriate. 3.2 Management Review Team(MRT) is responsible for: o the effective implementation of this policy o tracking follow-up on corrective and preventive actions 3.3 Customer Support is responsible for: o Receiving and routing customer complaints regarding product quality to appropriate functional areas, and if required, consulting with the Quality Management Representative(QMR) to determine appropriate functional area to contact. o Coordinating communication with the customer as appropriate. 10.0_r UNCONTROLLED IF PRINTED page 1 of 2

25 10.0 Corrective and Preventive Actions Rev-00 / Approved by: Wanda Horne 4.0 References none 10.0_r UNCONTROLLED IF PRINTED page 2 of 2