Standard Operating Procedure for Document Storage, Archival, and Retrieval

Transcription

1 SFWMDDVSSOP Standard Operating Procedure for Version 3 Effective Date: Upon Final Approval Prepared by: Marina Gosis, Senior Scientist, Analytical Services Section Date: Approved by: Michael Wright, Section Leader, Analytical Services Section Date: Approved by: Zdzislaw Kolasinski, Section QA Officer, Analytical Services Section Date: Approved by: David Struve, Section Administrator, Analytical Services Section Date: Data Validation and Stewardship Analytical Services Section South Florida Water Management District 8894 Belvedere Road Bldg #374 West Palm Beach, Florida *This is not a controlled document. The most current version is available on the Analytical Services Section webpage.

2 Page 1 of 15 Table of Contents 1.0 Purpose Scope and Applicability Definitions Procedures Annual SOP Review References SOP History 6 Appendix A..7 Appendix B..9 Appendix C 11 Table 1 14

3 Page 2 of Purpose The purpose of this standard operating procedure (SOP) is to outline guidance for Storage, Archival and Retrieval records by the South Florida Water Management (SFWMD) Laboratory and Analytical Services (AS) Section Data Validation Unit (DVU). 2.0 Scope and Applicability This SOP covers record organization, storage, archival and retrieval in Restoration Sciences Department, Analytical Services Section for Data Validation and Laboratory. This SOP guides staff in the following major processes: Filing field/laboratory analytical reports from internal and external laboratories; Processing documents for onsite/offsite storage; Document retrieval and return. 3.0 Definitions Chains of Custody (COC): an unbroken trail of accountability that ensures the physical security of samples and includes signatures of all who handle the samples and includes the signatures of all who handle the samples. Electronic Data Deliverable (EDD): an electronic data deliverable based on elements needed for data validation and assessment. These include the Laboratory Data Deliverable (LDD) and the Laboratory Receipt Deliverable (LRD). The Laboratory Data Deliverable contains sample result information and also includes all associated quality control (in the case the internal validation associated quality control is not included in EDD). The LRD contains sample information contained in the chainofcustody (COC). NuGenesis: an automated electronic repository that stores and manages all types of scientific data to a centralized database, offering integration with a multitude of research applications. Work Order (WO): a set of samples that come from the same profile and are related in some way. For instance, it may be a set of samples collected from a single project to be reported together on the same final report. 4.0 Procedures 4.1 Documentation Maintained for Storage, Archival and Retrieval Effective January 1, 2007, documents should be scanned and stored in NuGenesis whenever possible. The District incurs great expense for the storage and retrieval of paper documents. In summary, off site document storage presently consists of:

4 Page 3 of 15 District laboratory Quality Manuals (QMs), Standard Operating Procedures (SOPs), Performance Testing studies (PTs), correspondence and certifications dated prior to January NELAC District laboratory Certificates and Laboratory Scope of Accreditation and correspondence dated prior to January 2007; Onsite Assessment Reports and the Statements of Deficiencies and Plan of Correction, External, Internal and Management Audits Reports and correspondence dated prior to January 2007; District Demonstration of Capability Certificates dated prior to January 2007; Annual Verification of Method Detection Limits prior to January 2007; Laboratory policy and guidance documents developed prior to January 2007; External laboratory QMs, Performance Evaluations (PEs), correspondence and certifications dated prior to January 2007; District and external laboratory chains of custody (COCs) prior to December 31, 2006 are stored off site. District laboratory instruments raw data and digestions log books prior to December 31, 2006 are stored off site. Beginning January 1, 2007 instrument raw data are scanned in NuGenesis, but digestion books are still stored in outside storage facility; External laboratory documentation prior to December 31, 2006 are stored off site including external contract laboratory purchase requisitions and invoices; External laboratory data packages prior to December 31, 2006 are stored off site. All documents produced by District and external laboratories after January 2007 are presently stored as followed: All correspondence and data files delivered to the District from offsite Laboratories electronically. External laboratory COCs and data packages are stored in NuGenesis associated by work order (WO). Electronic data deliverables (EDDs) of the data packages are stored indefinitely on the WQA server at: \\ad\dfsroot\data\kb_wqa\data VALIDATION. External laboratory contract documentation, laboratory certifications and related correspondence scanned and stored in NuGenesis for permanent storage. District laboratory batch work lists (BWs) and instruments raw data are stored directly into NuGenesis associated by work order. District laboratory QMs are maintained by Laboratory QA Officer and stored in NuGenesis. District laboratory COCs, SOPs and PEs are stored in NuGenesis. Hardcopies of COCs (originals) are scanned into NuGenesis.

5 Page 4 of General Filing System for Documents External Laboratory Documentation All external laboratory documentation is delivered electronically: All analytical data packages, contract documentation, audits, QMs, certifications, and PEs are stored in NuGenesis; External laboratory reports and COCs are stored by external laboratory name and date, as well as by WO in NuGenesis; External laboratory EDDs are stored indefinitely on the WQA server directory or on CDs in the order of year, external laboratory name, and project; District Laboratory Documentation The procedure for filing District laboratory documentation consists of the following: After final review by the Laboratory QA Officer, batch work lists are filed by staff in the Analytical Services section by analyte and Horizon Batch Number (HBN). A record of each BW is documented before filing. It was done prior to year After year 2007, BWs are scanned and stored directly into NuGenesis; Internal COCs are filed by laboratory staff in the laboratory section by collection date. COCs prior to year 2007 are filed by LIMS number. Post2007 internal COCs are also scanned and stored in NuGenesis by WO; Digestion logbooks are filed by laboratory staff in the laboratory section by digestion date prior to year Post 2007 internal digestion logs are scanned and stored in NuGenesis by WO; District laboratory EDDs and corresponding validation narratives are stored indefinitely in the WQA server directory or on compact discs in the order of Week Ending date. 4.3 Preparing Documents for Archive No documentation, which must be stored in outside storage, is being accumulated in current years. 4.4 Records Retrieval/Return and Retention Records Retrieval Once a request for records retrieval has been received, refer to the Data Storage Log to determine which carton needs to be retrieved from storage. Follow the instructions for Retrieve Boxes from Offsite Storage (Appendix A); Document in the Data Storage Log the requestor s name and address for tracking purposes; When the driver arrives for pickup/delivery, obtain a receipt.

6 Page 5 of Records Return If records are ready for return to storage, follow the instructions for Return Boxes to Storage (Appendix B): Update the Data Storage Log by removing the requestor s name and from the log once the box is returned; Save and file receipts for pickup/delivery in the Records Management binder Records Retention By law, this agency s Records Management Liaison Officer is required to submit to the Department of State a Records Management Compliance Statement attesting to the fact that the agency is in compliance with Section (5), Florida Statutes, and Rule 1B24.003(9), Florida Administrative Code, for all public records regardless of media or format. It is the responsibility of the Records Coordinators to dispose of District Records in accordance with Florida Statutes and District guidelines which requires written authorization prior to destruction from the Records Management Specialist. The Records Management website, located under the District Clerks Office, contains guidelines and instructions for the disposition of records. The Department of State recently revised the General Records Schedule for state and local government agencies. The changes became effective on June The revised schedule is now available on our website See SFWMD Retention Schedule & Disposition Form 06/2014. In 2012, the AS Section developed a supplemental document retention policy which summarizes, clarifies, and documents records retention requirements specifically for the District Laboratory (Appendix C). Retention requirements for AS Section s records were often ambiguous due to the existence of multiple guidelines and federal and state regulations governing laboratory data. Additionally, overall lack of process resulted in the retention of unneeded or nonrequired records that lead to in excessive storage costs, lack of control and inefficient document access. The current retention policy provides for the systematic destruction of records received or created by the AS Section (Table 1). It is designed to ensure compliance with pertinent and applicable laws and regulations, eliminating inadvertent destruction of important records while facilitating AS Section operations by promoting efficiency and reducing storage costs. 5.0 Annual SOP Review This SOP will be evaluated on an annual basis to determine if any changes are necessary. This annual review will be documented even if no changes are necessary. Any revisions to SOP will be tracked in the District s document control system and in section 7.0 of this SOP.

7 Page 6 of References FDEP (Florida Department of Environmental Protection). (2008). QA Rule Chapter Florida Administrative Code, Effective July DEP, Tallahassee, FL. Available online at: National Environmental Laboratory Accreditation Conference (June 5, 2003) NELAC Standard. SFWMD (South Florida Water Management District). 2013). Chemistry Laboratory Quality Manual. Analytical Services Section, South Florida Water Management District, West Palm Beach, FL _clqm_final.pdf FDEP (Florida Department of Environmental Protection). Letter for Records Retention Requirements per Chapter 62160, F.A.C dated July SOP History Document Version Date Issued Description Author 01 October 2007 Initial creation of SOP Sharon SmithTembe 02 September 2010 Updated entire SOP due to offsite storage company change Marina Gosis 03 December 2014 SOP format was changed according to SOP for SOP. Updated the Preparing Documents for Archive paragraph. Updated Record Retention Paragraph. Updated References. Requesting Barcode Labels Appendix was eliminated. Document Retention Policy for the Analytical Services Section (Appendix C) wit Table 1 was added. Marina Gosis

8 Page 7 of 15 APPENDIX A Retrieve Records from Offsite Storage Login to After logging in press Query and then Boxes/Containers :

9 Page 8 of 15 Next, fill in reference fields needed and click List : Your order can be viewed by clicking View order or by pressing Add order. Checking Submit box will be moved to check out:

10 Page 9 of 15 Login to APPENDIX B Sending New and Returning Boxes to Offsite Storage Click on WEB ACCESS LOG IN. Next, type your User Name and Password to login:

11 Page 10 of 15 Click on Request, then Miscellaneous. Choose Pick up Boxes in Services area. Type the quantity in Quantity area. If comments are needed, type the comments in the Comments area. Finally, press Add Order button to submit. Click Send Order to proceed to check out.

12 Page 11 of 15 APPENDIX C Document Retention Policy for the Analytical Services Section Document Retention Policy for the Analytical Services Section South Florida Water Management District Rationale for Policy/ Purpose The South Florida Water Management District (District) Analytical Services (AS) Section is committed to effective records management including: meeting legal requirements for record retention, optimizing the use of storage space, minimizing the cost of record retention, and properly destroying outdated records. The AS Section retention policy intends to summarize, clarify and document records retention requirements for the District's AS Section. Currently, retention requirements for some AS Section's records are ambiguous due to the existence of multiple guidelines and federal and state regulations governing laboratory data and lack of process, resulting in the retention of unneeded or nonrequired records that result in excessive cost, lack of control and inefficient document access. This retention policy provides for the systematic destruction of records received or created by the AS Section. It is designed to ensure compliance with pertinent and applicable laws and regulations, eliminating inadvertent destruction of important records while facilitating AS Section operations by promoting efficiency and reducing storage costs. Policy Statement The AS Section requires that its records be retained in a systematic manner, meeting or exceeding minimum retention times, consistent with applicable law. The intent of this policy is to clarify record retention periods for laboratory and validation documents commonly created or received by the AS Section. Scope The AS Section retention policy applies to all master records generated by the District laboratory, as well as Data Validation and Stewardship Units, regardless of whether they are maintained in hard copy (paper) or electronically.

13 Page 12 of 15 This policy applies to all employees within the AS Section. Employees are expected to follow all District documentation protocol and are required to comply with the documentation standards outlined in this policy; compliance failure could result in disciplinary action. Employees with questions about this policy should consult with management. Procedures The AS Section retention policy endorses the records retention schedule outlined in Table 1. Records not listed, but similar (as defined by AS Section management) to those listed in the schedule, will be retained for the same length of time. Documents generated by the AS Section that are not listed in Table 1 should follow customary retention schedules maintained by the District's Record Management Office. This document establishes the minimum number of years that documents commonly created or received by the AS Section will be retained prior to destruction eligibility. Documents may be retained longer under special circumstances or for unique contractual reasons. In accordance with Chapter 119, Florida Statutes, Public Records Law and Chapter 257, Florida Statutes, Public Libraries and State Archives, public records may be destroyed or otherwise disposed of only in accordance with retention schedules established by the Florida Department of State, State Library and Archives of Florida. Documents retained offsite must obtain written authorization (via a Records Disposition form) from the District's Records Management Office. Roles/Responsibilities AS Section, Quality Assurance Officer Oversees the maintenance and storage of records in accordance with QA guidelines and District policy. AS Section, Laboratory and Validation Section Staff Maintain individual files AS Section, Records Coordinator Maintains central files. Prepares files for archive. Retrieves archives files. Records custodian. Maintains listing of archived files. References 1. Guidelines for Records Disposition, Office of the District Clerk, Records Management Section, SFWMD, West Palm Beach, Florida 2. SFWMD Retention Schedule Approved by the State of Florida, maintained by the SFWMD Office of the District Clerk, Record Management Section 3. Chapter 119, Florida Statutes, "Public Records Law" 4. Chapter 257, Florida Statutes, "Public Libraries and State Archives"

14 Page 13 of QA Rule Chapter Florida Administrative Code, Florida Department of Environmental Protection; DEP, Tallahassee, Florida 6. Chapter 1624, Florida Administrative Code Public Records Scheduling and Disposition 7. National Environmental Laboratory Accreditation Conference (June 5, 2003) NELAC Standard. Chemistry Laboratory Quality Manual (2011), Water Quality Analysis Division, SFWMD, West Palm Beach, Florida 8. Standard Operating Procedure for Document Storage Archival and Retrieval, DVSSOP Version 2.8, Water Quality Analysis Division, SFWMD, West Palm Beach, Florida 9. Correspondence from FDEP to Dr. Ming Chen, SFWMD, dated March 17, 2009, Subject: Record Retention Re uirements per Chapter 62160, FAC Analytical Services Section Approval date: 1/6/12 David M. Struv, Review Administrator Cycle: Annually

15 Page 14 of 15 S c Wh Me D d ul L Ae B N TABLE 1 South Florida Water Management District Analytical Services Section Retention Schedule Generated Ite m it Record Series Title and Description Retention of Record Also Known As 1 Sample Submission Documentation: This record series consists of Chain of Custodies 10 Yrs Header sheets; (COCs)(both internal and external), COC Corrections, Field Data Reports, Field Notes, and Prelogin Summary Sample Mixup/Improper Preservation documentation Reports; Header Corrections; FDRs; 7/5/2012 Referenced Retention Schedules NELAC Standard, 6/5/03, Chapter years retention WMD30, Item 5. Chemistry Field Data Logs are to be retained 1 year after data is keyed into database Chemistry Field Data a Logs W Laboratory 2 Analysis: This record series consists of records pertaining to Laboratory 10 Yrs m Laboratory NELAC Standard, 6/5/03, Chapter years M Instrument Analysis (e.g.. Instrument Runs and Reports, Digestion Logs, Autoclave De Analytical Reports; retention Logs, Volume Logs, QC checklists) Final Reports WMD30, Item 23. Quality Control Logs are to be L retained 1 year after data is keyed into database W 3 A M Quality Assurance and Quality ControlData: This record series consists of records B 10 Yrs MDL/PQL NELAC Standard, 6/5/03, Chapter years D pertaining to Data Quality (e.g.. Method Detection Limit/Practical Quantitation Limits, retention L Uncertainty Constant K Values, Method Validation Packages) A W Laboratory 4 Certifications: This record series consists of Audits and Audit Responses, B M Performance Evaluation Studies and Laboratory Certifications 5 Yrs DOH Audits; PE NELAC Standard, 6/5/03, Chapter years D Studies retention L W Laboratory 5 Calibration & Capability: This record series consists of Calibration & COA; IDOC; CDOC A M B 10 Yrs NELAC Standard, 6/5/03, Chapter years D Capability Records (e.g.. Certified Weight Calibrations, Certificates of Analysis; retention L Temperature Logs; Initial Demonstrations Of Capability/Continuing Demonstrations Of A Capability) W Standard B 6 Operation Procedures and Manuals: This record series consists of Data Permanent SOP; QM; CLQM M NELAC Standard, 6/5/03, Chapter years D Validation & Laboratory SOPs (e.g.. Method SOPs, Procedural SOPs, Laboratory Quality retention L Manual, etc.) WMD28, Item 25. Technical Reports and Documents A (i.e.: SOPs, Manuals) shall be retained permanently W B DBHydro 7 Corrections: This record series includes DBHydro Correction request forms, by the District M Project Manager Remark requests & supporting documentation Permanent PMR requests NELAC Standard, 6/5/03, Chapter years D retention L WA Data 8 Validation Documentation: This record series consists of records pertaining to 10 Yrs Header corrections NELAC Standard, 6/5/03, Chapter years B

16 Page 15 of 15 M D L A WB M D L A COC and Narrative Corrections to include Validation Narratives, LIMS correction requests and associated supporting documentation retention External 9 Contract Laboratories: This record series consists of Laboratory Final Reports 5 Yrs Final Reports No retention criteria exists received from SFWMD Contracted laboratories. These records typically report analytes contracted to outside laboratories. NOTE: This table i intended to clarify retention requirements for documents commonly created or recieved by the AS Section. It is not intended to be all inclusive. For retention B requirements for documents not Hs ed on this table, please refer to the SFWMD Records Management Department, and the SFWMD Retention Schedule Approved by the State of Florida.