Presented by: Catherine Katsikis, LDCFL, Inc , FSEA May 2013 Spring Technical Session

Transcription

1 Presented by: Catherine Katsikis, LDCFL, Inc , FSEA May 2013 Spring Technical Session

2 Purpose Definitions Common problems Document Control Implementation Examples Document Archival/ Retrieval Implementation Summary References

3 Ancient Egyptians wrote their history on walls, because they were smart enough to know that, if they put it in the files, it would be lost forever. (from a cartoon)

4 According to F.A.C. FDEP QA Rule Documents and records must be accurate, complete, current, traceable, maintained, protected, and controlled F.A.C.: Florida Administrative Code FDEP: Florida Department of Environmental Protection

5 Multiple references in NELAC/TNI Quality Assurance Plan 4.3 Document Control (ISO/IEC 17025:2005(E), Clause 4.3) 4.13 Control of Records Control of Data

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7 Document Control The process of managing, distributing, and controlling documents. The act of ensuring that documents and revisions to the documents are proposed, reviewed for accuracy, approved for release by authorized personnel, distributed properly, and controlled to ensure use of the correct version at the location where the prescribed activity is performed (ASQC, 1996). ASQC= American Society for Quality

8 Revision(s) time management, distribution, training. Document control of External documentation Too many documents, difficult to maintain. Inconsistent use of other documents (forms, templates, memos, maps, etc.). Electronic distribution.

9 Discuss your organization s needs. Create or adapt a Document control Standard Operating Procedure (SOP), or policy. Train employees. Ensure understanding of SOP/policy. Follow through and test the procedure. Periodic review of SOP/policy (usually an annual review).

10 Quality Systems related documents (Quality Manuals, SOPs, reports, research documents, field notes, forms, logbooks, etc.). Technical related documents (monitoring plans, methods manuals, policies, other written instructions or directives etc. External documents (if distributed as a new procedure, rule, directive, etc.).

11 Create a record log (paper or electronic) Record: Document Control ID (unique) Name of document Creator Date created Approval date Revision or version Retired date etc. Don t forget to give a document control ID to the record log

12 Controlled Copy A hard copy of a document that is uniquely identified such that the organization can maintain control over the use and fate of the copy. The location of a controlled copy or identity of an individual receiving a controlled copy is recorded such that the document can be recalled as needed.

13 Create a traffic control log (paper or electronic) Record: Document Control ID (unique) Name of document Revision or version Control copy number Received By Date of Receipt Date of Withdrawal Withdrawal By Destroyed By etc. Don t forget to give a document control ID to the traffic control log

14 Challenging to control. Keep distribution list. At minimum, ask for READ follow up (if is used). Add clause. Document procedure in SOP/policy/QMP.

15 If you are converting to a virtual system, be sure to carefully document how the original document will be stored, if at all. Have a backup solution. If changing to an automated system, use a pilot roll out strategy. After full conversion, wait a few months before destroying or filing paper documents.

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17 DC#: SCLOG Rev.1 Template approved By: Date:

18 Log ID: Chemicals 001 Rev.1

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20 Log ID: Maintenance log GCA 001 Name: From: to: Department: Control copy:????

21 Archived Document A document or version of a document that is outdated and no longer authorized for use in a designated area (electronic or physical) and is placed in a document archive for historical preservation and reference.

22 Paper (Documents, Maps, logbooks, Memos, QMPs, etc.) Electronic ( Saving in the right format, keep device that can read archived documents, when scanning use the proper pixel resolution.) Documents staying on site, or outside storage. Storage facility should be air conditioned, protected against fire, theft, loss, environmental deterioration, vermin and, in the case of electronic records, electronic or magnetic sources. Appoint approved personnel for external record retrieval.

23 Create storage/archival log(s) (paper or electronic) Record: ID of Storage vehicle (box, cabinet, ) In house Location (room, shelve #, file cabinet #, etc.) Document Control ID (unique) Name of document Section Date stored By whom Duration?? Don t forget to give a document control ID to the record log.

24 Create storage/archival log (paper or electronic) Record: ID of box Document Control ID? Name of document? Date of move to outside storage Facility Facility s box ID label (barcode, pre printed IDs.) Contact info Date of move Storage duration Don t forget to give a document control ID to the archiving log.

25 TNI V1M2: e) Access to archived information shall be documented with an access log. Internal Access /Retrieval Log Record: Don t forget to?

26 External Access/Retrieval Log Record: Box ID Document ID Requested Date/By Arrival Date Section Purpose Contact phone or Return date/by Etc.

27 The time of archival will depend on the organization/project/type and their applicable requirements as defined by the End User, Florida Administrative Code, FLDEP, EPA, etc. Examples: TNI: five (5) years from generation of the last entry in the records. Currently: FDEP 5 years after project completion (i.e. permit) Upcoming: FDEP 5 years after the date of generation or completion of the records Identify the different types of retention period requirements. Examples: Fiscal year? Calendar year? Anniversary year? Months? Days? Triggering event?

28 FD1100: Keep records of all original data as well as records of all reduced or manipulated forms of the original data. Original: Raw instrument data, field notes, etc. Manipulated: Reports of field sampling and testing results, etc. 1.3 Electronic records are acceptable as documentation and are considered to be equivalent in status and function to original records, documents or papers, unless otherwise specified in a DEP contract, order, permit or Title 62 rule Electronic copies intended to replace original records must contain the same information as the original records, regardless of whether the electronic copies are designated as master or duplicate records Electronic copies of original records can be designated as master copies for storage purposes. 1.7 Retain copies of all revisions of all cited documents as part of the documentation archives.

29 Protect revised or retired documents from unintentional use. Segregate or destroy obsolete documents. Remember to always keep and identify the main document (paper/electronic) for historical reference. Keep records of documents location.

30 Document control is probably one the most important part of the quality system in an organization since nearly every action is driven by it. Document Control will be successful if it is made simple and understandable. The minimum document control elements should be consistently placed on each page of the document, normally in the header and/or footer. Keep record lists to track and access the documentation.

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33 . LDCFL, Inc. Catherine Katsikis, LDCFL, Inc