1. Document Control Without Commercial Software Susan Humphries* Formerly: Florida Department of Agriculture Food Lab Currently: FDA–PRLNW *Note: the opinions expressed here are entirely my own, and based on my experience at the FDACS (State) Food Laboratories

2. Why control documents? O ISO 17025:2005 -“Say what you do, do what you say” O Reconstruct procedure O Protects: O Public health! O Our staff’s reputations O Courtroom testimony O Continuous improvement O Efficiency – saves money and time

3. Audits and Documents O 3 rd most frequently cited type of deficiency (A2LA) “…use of uncontrolled instructions in the lab and failure to control externally-generated documents…”

4. Participation – Why are YOU Here? O Who has a functional system? How happy are you? O Manual? Rate… O Purchased? Rate… O Who wants to make improvements? O Who does not have a system in place and is building or just planning one? O What is your timeframe? O Are you planning to purchase or build in house?

5. Myths of Commercial Software O It will fix the problem of unauthorized copies O It will automatically mark all changes in the document’s text O It will always run smoothly without attention O We won’t have to talk to each other when revising documents… O It doesn’t require trained and motivated staff O It’s got built-in training, so we won’t need to train

6. “Control” - What’s that? O Documents (internal, external) - Instructions for work O Record – Written observation; what has been done. O Controlled – Protected against unauthorized use. O Authorization/approval – a RECORD.

7. What’s Required O Docs current O Readily available O Clearly ID’d: Date OR version O AND Page x of y, OR a mark O Issuing Authority O Master List: O Readily available O All docs w/version and distribution O Obsolete or invalid documents are removed from point of use

8. More Requirements O Periodic review/revision O Review/approval before issue O New or altered text ID’d O Policy - hand amendments O Notification of issue/revision O Procedures for handling of documents in electronic systems to be defined O Marked if not current O Calculations/software ops verified

9. Options O Electronic only O Paper only O Exp date? O Hybrid

10. Common features: Pluses O When properly implemented, staff have access to current docs ONLY, ideally ensuring: O Work from correct versions O Defensibility O Meeting standard requirements: no deficiencies

11. Common features: Minuses O Very labor intensive O Depend on: O Robust systems O Skilled and trained staff (all!) O Electronic systems O Training O Extreme attention to detail

12. Input/feedback O All electronic (noncommercial)? Thoughts? O All paper? Thoughts? O Hybrid? Thoughts?

13. In-house resource needs O IT support: O Network folders, (for electronic docs) O Access restrictions (electronic) O IT/tech resources: O PCs/tablets at point of use; color laser printer? O IT staff time O Software O Required: Word, Excel, Adobe Pro O Optional: Access, SharePoint, SQL, etc. O Staff time: 1/2 to 1 FTE for doc control, pub, training, records mgmt.

14. Required Records O Master list: O Documents O Version O Distribution O Reviews/approvals, by date/person O Pre-issue O Periodic O Notification of issue/revision O Verification of Calculations/software ops, by date/person

15. Defining your workflows O List the things that happen to docs: O Writing and issuing a new document O Revising and reissuing a document O Retiring a document O Ensuring document revisions are done on schedule, and recorded O Think about these tasks for both internal and external documents

16. Defining workflows, continued O Simple flowcharts, and/or post-its O Use a different color for where records are captured O Establish responsibilities by role

17. Creating spreadsheets O Excel or Access most common O What can be done on paper? O Approval signatures (on change request, or in doc) O Reviews O Checklists can be helpful, grid type is good O Access can generate hardcopy distribution sheet, staff can initial/date

18. Defining electronic management O How docs are handled/protected from unauthorized changes/kept current O Is required

19. Implement and test electronic side O SharePoint O Adobe cloud O Folder restrictions

20. Defining paper management O Walk it through O Where could it fail? O Get supplies! O Inboxes, file folders, binders, hole punches, rubber stamps (Draft, Archival copy, Audit Copy), paper clips

21. Walk-through: New doc, hybrid system O Anyone starts a draft, gives title and requests ID number from QA staff O QA person records draft in ML, issues number to author O Document templates are handy O Author completes document (can collaborate) O Fills out form (checklist for new SOPs) O Hands form to reviewer for review and signature

22. New doc, continued O Once author has approval signatures on forms, puts doc in QA e-folder, form in QA inbox O Form moved to binder; QA staff reviews and finalizes in NON-accessible folder, including version and date updates in document. O QA staff prints a copy, attaches approval form, takes to final issuing authority for last hardcopy signature

23. New doc, continued O Signed doc archived in QA binder. Old copy stamped “archival”, moved to records binder. O Spreadsheet updated to mark old copy retired (and date), add new copy information O Hardcopies and distribution list printed and distributed (with signature form if desired) O Electronic copies of new doc locked and placed in accessible folder.

24. New doc, continued O Distribution list placed in folder w/QA staff, each obsolete hardcopy is checked off when returned. O When sheet completed, distribution records spreadsheet updated.

25. Thanks to everyone! O Florida Department of Agriculture and Consumer Services O APHL O FDA