Deviation Management: From Discovery to Reporting

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1 Deviation Management: From Discovery to Reporting The Practical Side of What to Do Nancy H. Collins, PhD. The University of Toledo Medical Center Dept. of Medical Microbiology & Immunology

2 What are Deviations? Defined as unexpected or unplanned departures from regulations (cgmps or cgtps), SOPs, standards, or specifications that may affect product safety, quality, identity, potency, or purity Many names: error, occurrence, accident, failures, variances, nonconformance, sentinel event, near miss, complaint, adverse event, discrepancies, or problems Response to deviations described by CAPA (corrective and preventive actions) CAPA accounts for large percentage of FDA 483 reports Planned deviations share some elements, but usually simpler and may not warrant investigation

3 Purity Reporting Review D e v i a t i o ns Labeling Donor eligibility Complaint file Mix-up Testing a r e s c a r y Supplies& Reagents Equipment Equipment Storage

4 How to handle a deviation: The practical approach Deviations will happen both planned and unplanned. It is the role of the QM system to use them to improve lab practice. QM is its own science, with its own vocabulary, evolutionary development Can t expect to keep pace with all those MBAs and Quality Specialists developing the science, so Apply scientific thinking Something has gone wrong. Let s find out how why it happened and prevent it from happening again, if we can. A logical approach will get you through!

5 Deviation Management: an Integral Part of the QM Web Quality Management Program is a web of interconnected threads connecting all parts of laboratory and clinical practice When a deviation happens, it affects all of the web Deviation Management (DM) informs all other systems (audit, process control, change control) DM parameters can be drawn from standards & regulations Doesn t matter where you enter the system (deviation discovery, audit, reporting, root cause analysis, process improvement), you must deal with all the rest of the Quality elements

6 Deviation Management Building Blocks Recognition & detection Immediate correction? Report (internal & external) Analysis (track & trend) Prevention of recurrence (improve process) Evaluation Process improvement Evaluation of DM operation

7 Lifecycle of an Planned Deviation (1) Advance knowledge & approval Physician or member of transplant team reports potential deviation to responsible laboratory member before processing begins Reason clearly stated in report Develop strategy or plan (e.g., labeling, documentation) Processing Facility Lab or Medical Director signs off on plan. Immediate (or short term) corrective actions taken if necessary. Deviation reported to internal team & regulators through specific documents.

8 Lifecycle of an Planned Deviation (2) Relevant parts of DM procedure initiated: Quality Management notified in specified time frame (e.g., immediately or within one day). QM evaluates deviation & assigns deviation classification & level as specified in QM plan QM Manager assesses any potential impact to lab practice. Long term preventive action needed? Follow up: was preventive action successful?

9 Practical Tip #1: Planned Deviations can be used to train personnel in proper DM Clear communication between lab, patient s physician, clinical team, quality team & other responsible personnel Preparative actions/education are taken. Label & document appropriately!

10 Lifecycle of an Unplanned Deviation (1) Any laboratory member, supervisor or designee detects deviation during or after processing Immediate (or short term) corrective actions are taken as necessary. ( CA from CAPA) Short, unambiguous report initiated as soon as possible. Deviation reported to patient s physicians. Medical director authorizes release of product if warranted. Clinical Program Director & Governmental regulators notified as necessary DM procedure initiated: Quality Management notified in specified time frame (e.g., immediately or within one day). QM evaluates deviation & assigns deviation classification & level QM Manager assesses potential impact to lab practice.

11 Lifecycle of an Unplanned Deviation (2) Investigation planned and executed. Level of investigation corresponds to level of deviation. Higher level deviations lead to more intensive investigations. Investigations should be timely (e.g., 30 days) Deviation reporting does not correct problem. Preventative action ( PA from CAPA) corrects problem. Thorough investigation into the root cause to prevent future recurrences. Long term corrective actions are taken. Note: AABB/ISCT session Change control workshop Technical Track 13, Wednesday 11 am, Liberty Ballroom B Deviation records Filed in patient records, or with batch report Deviation information & CAPA activities Enter QM reporting system, audit report, complaint record, or safety investigation report as appropriate.

12 DM Reporting System Regulations require that deviations are captured so that all processes and systems are continuously improved. Deviations must be Recognized Categorized by system affected Ranked or assigned level of seriousness or impact Investigated DM reporting feeds into Corrective and Preventative Actions (CAPA)

13 Practical Tip #2: Design all parts of QM reporting around regulatory & standards requirements Determine critical systems or parameters from regulations & standards which require reporting, auditing, tracking & trending 351 vs. 361 products, IND/IDE requirements, Core GTPs (Facilities, Environment, Equipment, Supplies & Reagents, Recovery, Process Controls, Labeling, Storage, Receipt & Distribution, Donor Eligibility Determinations), cell numbers, viability, mix-ups, microbial contamination, engraftment Build reports to encompass these parameters Maintain central file of deviations classified by parameters Make internal & external reporting mechanisms as similar in language & content as possible Document, Document, Document!

14 Practical Tip #3: Design worksheets & reports to aid detection & reporting Simplify & standardize worksheets (e.g., all results & reviews in same place on page) Standardize how results are expressed (Exponents!!!) Clear expected results, ranges Highlight points in process for review Train personnel for consistency, to minimize individual interpretation (avoid over or under reporting) Is this a deviation? Clear instructions if out of range results occur (immediate correction, reporting) Deviations as a measure of lab functioning

15 Deviation Report Form Elements Planned Deviations Anticipated specifics (date, time, personnel, identifiers, responsible persons, reason, immediate corrective action if necessary) Root cause, if necessary QA assessment & approval (system & ranking, target dates, responsible person, closed date) Medical and/or Laboratory Director approval (target date, closed date, responsible persons) Follow up or APA (target date, open & closed date, personnel) if needed Additional data (keywords)

16 Deviation Report Form Elements Unplanned Deviations Specifics of event (date, time, personnel, detection date, identifiers, responsible persons, immediate corrective action) QA assessment & approval (system & ranking, target dates, responsible person, closed date) Medical and/or Laboratory Director approval (target date, closed date, responsible persons) Investigation with root cause Follow up or APA (target date, open & closed date, personnel) Additional data (keywords, case report, relevant documents)

17 Organized by category and by type Describe deviation and Action taken at the time it occurred Documentation of report to collection program

18 Follow-up correction actions Requirement for additional follow-up Final resolution Confirmation of collection program investigation report Review signatures Note: Would include Medical Director when relevant All reports discussed at laboratory meeting, if clinically relevant presented at program quality meeting

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23 Deviation Log Elements Manual or Electronic Report number & level Date Responsible person System Description Corrective Action Follow up Re-training Government report? Review Report # & Level Date of Report Reported by System Involved Brief Description Corrective Action Follow Up Retraining NYS DOH FDA Review

24 Practical Tip #4: Use Classification & Levels for Audit & Reporting Classification of Deviation by systems: Some deviations are unique to product Identification of system affected (e.g., Core GTPs) can help to focus on problem & may suggest improvement Levels of Deviation (High risk to low risk): Assignment to level based on the magnitude of event, seriousness, or perceived risk Introduces a metric that facilitates analysis Simplifies reporting

25 DM Metrics Example 1 Level 1: Critical Deviation from standards and/or regulations immediate and significant risk to product quality, patient safety or data integrity combination/repetition of major deficiencies that indicate a critical failure of systems Level 2: Serious Deviation from standards and/or regulations potentially significant risk product quality, patient safety or data integrity could potentially result in significant observations from a regulatory agency combination/repetition of "other" deficiencies that indicate a failure of system(s). Level 3: Standard Deviation less serious or isolated nature not judged to critical or major still require some correction or suggestions as how to improve systems or procedures

26 DM Metrics Example 2 Level I: Major Occurrence immediate harm to a patient, donor, or associate may result in harm to a patient, donor, or associate if immediate medical intervention does not take place. Level II: Major Occurrence potential harm to patient, donor, or associate. Level III: Medium level occurrence potential harm to a patient, donor or associate was obviated by detection of an error. Level IV: Low level occurrence no harm to the patient, donor, or associate

27 Practical Tip #5: Analysis determines extent of investigation and preventative actions Ask the following questions: Is this idiosyncratic to product? What is the extent of the deviation? Single batch? Previous batches? Have we seen this before? Is there a trend with similar cell types, products, supplies/regents, testing procedures, or other lab practices? What were the causes in similar occurrences? Should we reevaluate? Is there any regulatory impact? How do we prevent this from happening again?

28 EVEN BIGGER PROBLEMS

29 Practical Tip #6: If you believe NO investigation or NO CAPA is indicated, then document RESPONSIBLE PERSON & REASONING

30 Biological Product Deviations 361 Products: Deviation (21 CFR (dd) is unexpected or unforeseeable event that may relate to transmission or potential transmission of a communicable disease or may lead to contamination OR that is an unexpected or unforeseeable event that may relate to the transmission or potential transmission of a communicable disease or may lead to HCT/P contamination. 351 products: Licensed manufacturers report unexpected or unforeseeable events or deviations from current good manufacturing practice (CGMP), applicable regulations, applicable standards, or established specifications that may affect the safety, purity, or potency of a product (Title 21 Code of Federal Regulations (21 CFR ).

31 Biological Product Deviation For 361 and 351 products For DISTRIBUTED HCT/Ps related to a MANUFACTURING step, must report any HCT/P deviation relating to the core GTPs (systems in report) Reported on Form 3486 Biological Product Deviation Report within 45 days Use General Instructions and Guidance on BPD available on FDA website or call FDA for guidance

32 Flow chart for reporting BPD by Manufacturers of Licensed Products Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components

33 Practical Tip #7: Put definitions in SOP Manual or training materials easily available to personnel. Forms are easier to fill out if you understand them. Adverse reactions are deviations, and are always unplanned; However, unplanned deviations are not always associated with adverse events or reactions.

34 Adverse Reaction Reporting A noxious & unintended response to any HCT/P for which there is a reasonable possibility that the HCT/P caused the response (21 CFR (y)). Investigate any adverse reaction involving a communicable disease related to an HCT/P made available for distribution Must be reported if involving communicable disease if, fatal, or life-threatening, or resulting in permanent impairment of a body function, or damage to body structure; or necessitates medical or surgical intervention, including hospitalization 351: reporting requirements for drugs, medical devices, and/or biological products under the FFD&C Act and/or section 351 of the PHS Act Refer to links in Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

35 361 and 351: Adverse Reaction Reporting 361 : 351: Reported to FDA using Form 3500-A within 15 calendar days Refer to Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Reported to FDA using Form 3500-A within 15 calendar days Reporting requirements for drugs, medical devices, and/or biological products under the FFD&C Act and/or section 351 of the PHS Act Links to reporting requirements in Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

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