Page | of 6 ooe INDIAN. ACTS | STANDARD OPERATING PROCEDURE Clinical and Translational Sciences Institute Indiana CTST Specimen Storage Faclity TITLE: Standard Operating Procedure for Deviation Management CHAPTER: —1--Administration and Quality Oversight Issue Date: 0°7 13. 1S SOP #: SF-1-9.04 SUPERSEDES SOP#: N/A Effective Date: O77. /2. 1S AUTHORED BY: Gg LZ DATE: _0¢ Sue 2ors~ Indiana CTSI SSF Director Ose memos te Vile dated oxméeaeis. flo op juezou” QA APPROVAL: a DATE: _7. 43. 4S Quality Compliance Specialist 1. REVISION 1.1. Significant changes incorporated in this version include: 1.1.1. Edited Section 6.44 to clarify the description of the response. Updated Appendix A accordingly. 1.1.2. Updated Appendix B to include a field for documenting applicable SOPs. 2. PURPOSE 2.1. This Standard Operating Procedure (SOP) defines the procedures used in the Indiana CTSI Specimen Storage Facility (SSF) for documenting, investigating, and logging deviations. This procedure satisfies guidance set forth in ISBER “Best Practices”. ISBER Best Practices defines a deviation as an intentional or unintentional event that is a departure from a procedure or normal practice. Section E3.100 of ISBER Best Practices requires that: “Deviation reports are produced for all events that fall outside SOPs”. 3. PRINCIPLE 3.1. Deviations must be fully addressed to include documentation of the event, investigation of the cause(s), and a plan for preventing recurrence. This procedure is designed to address all of these aspects of a deviation through the corrective and preventative actions (CAPA) for continuous improvement approach. Deviations may be discovered through result of an audit, an observation by any SSF personnel or review by a clients and are distinctly different from Out of Specification Conditions (OOS); however, OOS conditions may result from or point to a deviation. Examples of occurrences documented as deviations compared to occurrences documented as OOS conditions are provided below. 3.1.1, Example of an QOS which is NOT a deviation: An SSP freezer is found to read below the acceptance range. The SSF technician addresses the reading according to the SOP, 3.1.2. Example of an OOS which is ALSO a deviation: An SSF freezer is being accessed and reaches a temperature of -65° C, The technician is aware that study personnel only requires a few more minutes to complete the specimen retrieval, acknowledges the alarm, and proceeds to assist the study personnel. The freezer is then closed when study personnel are SOP SF-1-9,04 SOP for Deviation ManagementPage 2 of 6 finished; however, the freezer has reached -58° C. The freezer fails to recover and, since the alarm was acknowledged fails to re-alarm. The unit is found at -5°C the following day. 3.1.3. Example of a Deviation not related to an QOS: An audit is being conducted and the auditor reviews the SSF visitor log. There are 2 non-SSF personnel in the Mechanical Refrigeration Unit Storage room; however, there is only 1 visitor logged in for the day. 4, SCOPE 4.1. This SOP defines the actions and responsibilities for all SSF personnel in the event of a deviation. Out of Specification (00S) conditions are managed per SOP SF-1-10. 5. MATERIALS S.A. N/A 6. PROCEDURE 6.1. DEFINITIONS Corrective Action — Action taken immediately to resolve the deviation. Preventative Action — Steps taken to prevent future occurrences of the same deviation Planned Deviation — An intentional departure from normal operation of SOPs. Root Cause ~ The most basic reason for an undesirable condition or problem that, if eliminated or corrected, would have prevented an event from occurring, 5. Unplanned Deviation ~ An unanticipated error or accident. .6. Planned/Unplanned Deviations ~ a deviation which has both an unplanned component and a planned component. 6.2, UNPLANNED DEVIATIONS Note: An unplanned deviation may occur in conjunction with a planned deviation. Additionally, multiple unplanned deviations which are related (e.g., an additional deviation may be discovered during the investigation of the deviation in question) may be documented together. 6.2.1. Upon discovery, immediately notify the SSF Management and QA. Notification needs to take place within 1 working day of discovery. 6.2.2. SSF Management and QA will advise regarding an acceptable immediate corrective action to minimize the adverse impact on stored specimens. 6.2.3. The person discovering the deviation initiates the Deviation Report Form (Appendix A) with the description and record of the immediate corrective action taken within 5 working days of discovery. 63. PLANNED DEVIATIONS 6.3.1. Planned deviations are first documented on a Deviation Report Form (Appendix A). Documented approval from SSF Management and QA is required prior to implementation of planned deviations. Copies of planned deviations may be kept with the SSF SOP or applicable form until the revised document is made effective (as applicable). 6.4, DEVIATION PROCESSING AND INVESTIGATION OF IMPACT 64.1, Obtain a deviation tracking number from QA. 6.4.1.1. The deviation tracking number is assigned as follows: D- YY-XX, where: D~ Indicates that the reference number pertains to a Deviation. YY ~ Indicates the last two digits of the year in which the deviation is initiated XX —Deviation Number (issued consecutively within year of occurrence) 6.4.2. SSF personnel initiate a Deviation Report Form (Appendix A). SOP SF-1-9.04 SOP for Deviation ManagementPage 3 of 6 64.3. Qu personnel record the deviation tracking number on the Deviation Report Log (Appendix B) 64.4. SSF Personnel proceed with completion Sections 1-5 of the Deviation Report Form (Appendix A) as follows: Decry Document the following information as defined below: vent Date - The actual date on which the event occurred Report Date ~ The date this report was initiated Deviation Tracking Number - Assigned 25 | Compete as soon as eee possible after deviation ‘Approximate Duration ~ The time elapsed | is discovered, Inform |_| from the apparent beginning tothe end of te | QA that a deviation deviation. Note: Deviations which have gone | has occurred so that a indetected fora long period should include an | number can be investigation to determine if potential quality | assigned as soon 2s ‘sien Improvements are needed Include | possible attachment of investigative reports as needed Person who discovered the deviation or designated alternate, Planned or unplanned - Designate as appropriate Planned/Unplanned — Delineate both the planned component and the unplanned ‘component separately within the deviation, ‘Angwer each of the lems as completely as possible, Applicable SOPs - Enter the SOP number that ‘was not followed. This may include | or more nities Description of the deviation and immediate response to remedy an existing situation and to Person who lessen potential impact includes what, who and | Complete as soon as _| discovered the 2 | when for esch point. possible after Section 1 | deviation or is complete designated alternate. Indicate the impacted area(s) as those presumed to be affected by the deviation. Document as “none” if there is no associated impact. Obtain and attach (with pagination) supporting documentation and reference the deviation number on associated SSF documentation, as appropriate, Document the results of the Investigation and Root Cause Analysis Complete Section 3 after Section 2 is, Person who ‘The root cause is determined by asking the | complete and as the | gieeevored the question “Why” repeatedly. For example: non | investigation authorized personnel were permitted access to | progresses. There may | ‘ specimen storage unit. deviation or designated bbe multiple entries on | aftemnate. + “Why: The SSF tech didn’t know the | different dates to person wasn’t authorized for access. reflect the history and SOP SF-1-9.04 SOP for Deviation ManagementPage 4 of 6 + “Wig? The SSF tech didn't review the ‘SF-1-4 submission form. + “Why”: (@ The SF-1-4 form was not available on the unit and. (b) the SSF tech didn't go locate the form + “Why: (a) The SSF Operations Manager *t know thatthe form was required to bbe posted immediataly and (b) the technician failed to follow defined protocol + Root Cause: (a) Inadequate SOP and (6) personnel need to be retrained Unmnutiple deviations are discovered during the course of the root cause analysis, include an investigation to determine if potential quality system improvements are needed. Include ‘attachment of investigative reports as needed. Obtain and attach (with pagination) supporting, documentation and reference the dev number on associated SSF documentation, as ‘appropriate. Docuinent the final assessment of impact and applicable additional response as defined by discussion to include the SSF staff completing the form, SSF Operations Manager and SSF Director. When applicable, the SSF Director notifies investigator/owner of the specimens. Obtain and attach (with pagination) supporting, documentation and reference the deviation number on associated SSF documentation, as appropriate, Complete after the SSF sta investigation is complete and applicable parties have discussed and reached ‘consensus Person who discovered the deviation or designated alternate, Document the preventive action and follow-up plan to include the date set for completion and responsible party. Not all deviations require preventative actions and/or follow-up. ‘The frequency, severity, impact and cause of the deviation are reviewed to determine if | preventative actions are required. Follow-up is. only required where the timeframe for the ‘completion of the preventative actions extends beyond the desired close-out date. Obtain and attach (with pagination) supporting documentation and reference the deviation umber on associated SSF documentation, as appropriate, Complete after the SSF staff investigation is ‘complete and applicable parties have discussed, Person who discovered the deviation or designated alternate. 6.4.5.1 6.4.5.2. 64.5.3. 64.5.4 64.5.5. 6. 6 Accuracy and completeness of the deviation description Completeness of the investigation Attribution of impact Complete Section 6 with signatures when signatory personnel agree to the following: Appropriateness of the corrective actions (immediate & long-term) Need for follow-up Both the appropriateness of the follow-up actions specified and the appropriateness of the time specified for completion. SOP SF-1-9.04 SOP for Deviation ManagementPage 5 of 6 6.4.6. Upon documentation of all signatory approvals, submit to QA for final close-out once all follow-up actions (as appropriate) have been completed. Provide evidence of completion of follow-up activities (as appropriate) to QA. 6.4.7. QA personnel complete the Deviation Report Log (Appendix B) oT De Ran Event Date Date of ocourrence As soon as known Deviation # ‘The reference number assigned = t AS soon as known Assigned By _| QA Initials and date assigned ‘After Completion of Section | Summary Description of the event, |? Of Deviation Report Form Description by SSF Personnel or upon ee een receipt of notification of the event ‘After final assessment by SSF Final Impact Equipment, Facility, Specimen, ete | personnel or upon receipt of report for signature Following signature by SSE personnel or upon receipt of report for signature Date of QA signature on Section 6 of fee ae Deviation Report Form Enter Yes/No to correspond to section 5 of Deviation Report Enter either “N/A* or enter the date Follow-up Req'd As above Follow-Up Upon receipt of evidence that complete completed (Grom section 7) and QM | sotowup is complete Enter Yes/No to correspond to > 60 days elapsed time between report initiation | YPOn reeeiPt of noticaion and QA close-out signature. eae Pl Comment Clarifying or reference information | As needed 6.4.8. Complete close-out of deviations within 60 calendar days unless the scope is such that it is not feasible to do so, When this occurs, note the reason in the deviation documentation. 6.4.9 All open deviations are reviewed in SSF meetings and may continue review until the recommended actions have been completed. 6.4.10. Once completed, the official date of deviation close-out is listed on Appendix B by QA and is determined once all corrective and preventive actions have been completed and documented as required. Supporting documentation may be added as it becomes available (2s applicable). QA verifies completion of Close Out and Follow-up by signing/dating Section 7 of Appendix A. |. REFERENCES 7.1, ISBER Best Practices (current version) DOCUMENTATION 8.1. Documents are retained in the SS Management (SF-1-6). F Operation’s office per the SOP for Controlled Document . APPENDICES 9.1. The current version of each of the following appendices is used to implement this SOP: SOP SF-1-9,04 SOP for Deviation ManagementPage 6 of 6 APPENDIX A: Deviation Report Form (1 Page) ‘APPENIDX B: Deviation Report Log (1 Page) ‘SOP SF-1-9.04 SOP for Deviation ManagementAppendix A. Page 1 of 1 eee INDIANACTS! ee cinicot ana Translations! Sciences Insnuie "ANDARD OPERATING PROCEDURE Indiana CTST Specimen Storage Facility 4. Reporting Information Event Date: Report Date: ‘Tracking Number: (O-yy-xx) Planned ‘Approx. Duration: pia Janne 22 Describe the Deviation’ — 2.3 Describe the Immediate Reso ‘Zi Make an iniial Impact Assessment: Specimens No O Yes (Describe Facilly C1 No_ClYas (Describe) Equioment No” Yes (Describe) ‘Other O No 0 Yes (Describe) Faeisroe Ds EXeeinene O No 0 Yes (# of pages) EA Sri kee CRIED eek GUC CeCe lich cies Cone) Dopeeser Ne) Aes XR No Gi Yes (# of pages), Cary ae nee rece een ‘G1 Assessment of impact unchanged from initial. No Additional Response required. TF Modification of initial assessment and/or additional response required as described below. Byte ny gee) No_ Yes (# of pages) Bianca ha en eens ser 5.1 What will be done to prevent a recurrence? | When will this be completed? ___ Whois responsible? 5.2 What documentation will demonstrate completion? ‘When wil his be completed?” "We oa PS otiate) aa No O Yes (Hof pages) pa Genser ‘SSF Operations Management SSF Director ‘Quality Compliance ACM ETE QA Verified/Date: responsible? jp Completed SF-1-9 SOP for Deviation Management Form Version 04£9 voIsiD, wH0s aw fe exn| scion] oC a 0 oN We] oN aw anna fxg) amavis) #40 “a ‘ ND we] eB xO Ag a doe s ono one ae mao ; oN ono aivD eee fra) acererune] eA0 ° ts vel oN x0 x0 : oN oN aw =O ‘wea woreidwoo] S24 0 iectateita a] . ox wate} oN a ot Pe eerie arr 4 ¢ oN ono =D AD Gay 2 °ND oN ‘ai vO is 20 sstiq wonsidwog) SoA sane ' oN we] eB seq | fare ou [avon ‘oaos | awanta | RAED | ayeq ee wondraasog wonessod | yey | pautnsy | POUBIEEY # | none aova ‘van ss Ce eee dot NoaINOLVIACass| FINTIIOALONILVATIO GIVANTL ISLOWNVIGNI ee 1 Jo | 98eg, B07] podey uoneiaag +g xpusddy: