Failure Investigation Anselmo

7/25/2019 Failure Investigation Anselmo

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FA ILUREFA ILURE

INVESTIGATION ANDINVESTIGATION ANDROOT CAUSEROOT CAUSE

ANALYSISANALYSISPresented By

Clay Anselmo, R.A.C.President and C.O.O.

Reglera L.L.C.

Denver, CO


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Lea rn ing Ob je c tive sLea rn ing Ob je c tive s

Understand the Definitions of Failure Investigation

and Root Cause Analysis (RCA)Introduce a common Failure Investigation and RCA

Process

Define 1271 Regulatory Requirements Related toFailure Investigation and RCA

Understand When and Where to Apply Methods and

ToolsTool Introduction and PurposeBest Practices

Provide Guidance on Documentation of Activit ies


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Definit ionsDefinit ions

Failure Investigation - The process of

understanding the key attributes of a particularfailure and identifying the likely causes of failure.

Root Cause Analysis The process of conductingan analysis to identify the physical, human, and

latent causes of a particular undesirable event.Root causes are specific underlying causes

Root causes are those that can reasonably be identified

Root causes are those that are controllable and fixable

Root causes are those where prevention is possible


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RegulatoryRegulatory

RequirementsRequirementsWhen is it REQUIRED to formally investigate (and perform

root cause analysis)?

1271.160 (b)(2) Ensuring that procedures exist for receiving, investigating,

evaluating, and documenting information related to core CGTP requirements,

including complaints

1271.160 (b)(3) Ensuring that appropriate corrective actions relating to core

CGTP requirements Documentation must include, where appropriate; (ii) Thenature of the problem requiring corrective action;

1271.160 (b)(6) Investigating and documenting HCT/P Deviations and trends

of HCT/P deviations relating to core CGTP requirements

1271.230 (a) Procedures. You must establish and maintain procedures for

review, evaluation and documentation of complaintsand the investigation ofcomplaints as appropriate.

1271.230 (b) Complaint File. The complaint file must contain sufficient

information about each complaint for proper reviewand for determining

whether the complaint is an isolated event or represents a trend.


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RegulatoryRegulatory

RequirementsRequirementsWhen is it REQUIRED to formally investigate (and performroot cause analysis)?

1271.320 (c) Review and evaluation of complaints. As soon as practical, youmust review, evaluate, and investigate each complaint that represents an eventrequired to be reported to FDA You must review and evaluate a complaintrelation to core CGTP requirements that does not represent an event requiredto be reported to determine whether and investigation is necessary When no

investigation is made, you must maintain a record that includes the reason noinvestigation was made.

1271.350 (a) Adverse reaction reports. (1) You must investigate and adversereaction involving a communicable disease related to an HCT/P that you madeavailable for distribution.

1271.350 (a)(3) You must, as soon as possible investigate all adversereactions that are the subject of these 15-day reports

1271.350 (b) Reports of HCT/P deviations. (1) You must investigate all HCT/Pdeviations related to a distributed HCT/P for which you performed amanufacturing step.


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Pro c e ss Ove rv iewPro c e ss Ove rv iew

Key Process StepsGeneral Problem Identification

Gather / Create Samples

Failure Investigation and Experimentation

Examination / Dissection / Physical Testing

Causal Factor Identification

Brainstorming

Use of tools (fishbone, causal factor chart)

Hypothesis Development

Linking Analysis Data to Causal Factors

Hypothesis TestingDOE / ANOVA / Simple Verification

Statistically Based Methodology

Root Cause Identification

Root Cause Map


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Pro c e ss Flow Cha rtPro c e ss Flow Cha rt

General Problem

Identification and

Basic ProblemStatement

Gather / Create

Evaluation

Sample(s)

Failure Investigation

and Experimentation

Causal Factor

Identification

Hypothesis

Development

Outcome

Consistent

with

ProblemStatement

Revise / Clarify

Problem Statement

to be Specific

Hypothesis Testing

and Verification

DataConsistent

w/

Hypothesis

Data Analysis

Revise Hypothesis

Final Root

Cause

Identification

Start


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Fa ilu re Inve stig a tio nFa ilure Inve stig a tio n

Common Tools / ActivitiesSample Dissection

Representative / Worst Case Sample Creation

Physical, Chemical, Human Factors Testing and Analysis

Environmental Stress Screening

Process CharacterizationProcedural Review


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Roo t Ca use Ana ly sisRoo t Ca use Ana ly sis

Common Tools / AnalysisFishbone Diagrams

Pareto Charts, Run Charts, other Control Chart Methods

ANOVA and Design of Experiments

Causal Factor Charting

Root Cause Map


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Ba sic Po in tsBa sic Po in ts

Use common senseUse tools when they support a comprehensive analysis, not just because they

are available.Right-Size the Investigation / Analysis be sure not to makethe problem more complicated than necessary

Avoid ANALYSIS PARALYSIS

Analyze the likely causes FIRSTUse feedback loops to refine problem statement and causalanalysis

Most problems have more than one root cause

Dont be afraid to ignore the instructionsUse the tools in a way that make sense for the problem. Tools are generic andmay need to be modified to fit your situation.

The problem dictates the tools, not the other way around


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ProblemProblem

Ident i f icat ionIdent i f icat ionDraft Problem Statement

Begin the process with a simple statement of the problem.

Do not define the cause in the problem statement. Keep an open

mind.

Create / Gather Samples

Gather evidence showing the existence of the problem.Product Returns

Collecting Documents

Creation of discrepant samples


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ProblemProblem

Ident i f icat ionIdent i f icat ionSample Evaluation

Samples may be tissue products, packaging, test results, records, etc.

Product Review

Sample Dissection

Physical TestingChemical

MicrobialPhysical

Functional

Records Review

Dates

ChangesRelationship to other relevant records

Chronology / History

Interviews

Duplicates in other locations


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ProblemProblem

Ident i f icat ionIdent i f icat ionProblem Statement Revision

Inspection / Testing / Review

Are results consistent with Initial Problem Statement?

Updated Problem Statement

Change Scope

Expand Scope

Reduce Scope

BE SPECIFIC based on observable data


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Id e ntify Lik e lyId e ntify Lik e ly

CausesCausesUtil ize Analysis Tools

Cause and Effect (Fishbone) Diagram

Causal Factor Chart

Process Flow Chart

BrainstormDo not rule out causes or assess likelihood

Look at all elements of the process

When in doubt start with 5 standard categories

Process

Environment

Materials

Human Factors

Equipment


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HypothesisHypothesis

De ve lo pm ent / Te stingDeve lo pm ent / Te stingCausal Analysis

Identify list of most likely causes (top 3 to 5)

Develop / utilize a rating scale or rating scheme (i.e. hazards evaluation)

Be specific so that the contribution of each cause can be evaluated

Hypothesis Development

Develop one or more scenarios to describe the failure based on thefailure investigation data and the causal analysis

Must be able to be evaluated / tested

Hypothesis Testing / Evaluation

Simple Inspection / Review of DataExperimental Design

Worst Case Analysis

ANOVA

DOE


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HypothesisHypothesis

De ve lo pm ent / Te stingDeve lo pm ent / Te stingData Analysis

Appropriate Statistical Methods

Does the Data Support the Hypothesis?

Yes Continue to Corrective / Preventive Action

No Revise Hypothesis or Causal Analysis

Maybe Further Experimentation is necessary

Hypothesis RevisionRevise Causal Analysis based on Experimental Results

Revise Hypothesis Statement

Retest as Necessary


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Pa re to Cha rtsPa re to Cha rts

Calibration Errors

13

2631

44 51

92

0

102030405060

708090

100

Janu

ary

Febr

uary

March

April

May

June

Month

Normalized

Quantity


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Contro l Cha rtContro l Cha rt

Average Production Hours

40 40 40 40 4044

46 4650 50

59

50

39 4040

25

30

35

40

4550

55

60

65

22 24 26 28 30 32 34 36

Week Number

Hours Mean

UCL

LCL


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M isc . Cha rtsM isc . Cha rts

Bar Temperature by Position

226

227228

229

230

231

232233

234

235

236

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

Position

Temperature

(C)


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Roo t Ca useRoo t Ca use

Ident i f icat ionIdent i f icat ionSummarize Results of Hypothesis Evaluation

Identify all root causes that significantly contribute to failure

Identify significant interactions between root causes

Prioritize root causes based on impact

Develop recommendations for:

Corrective Action (remedial action to correct items / units / tissues alreadyexhibiting failure)

Preventive Action (action to prevent recurrence of the problem)

Formally Document the Results


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Roo t Ca useRoo t Ca use

Sum m a ry Ta b leSumm a ry Ta b le

Bag Seal Failure Root Cause Analysis Summary TableRoot

Cause ID Description

Impact

(H/M/L) Siginificant Interactions Recommendations

1 Temperature Variation on Sealer Bar H

Temperature variability increases

dramatically with decreased sealingcycle time Replace sealer bar, increase calibrationfrequency, perform validation

2 Sealer Cycle Time H

Decreasing cycle time increases

temperature variation on sealer bar Specify minimum cycle time as 30s in SOP

3 Material Thickness M

Lower end of current specification does

not seal correctly at highest temperature

seen on sealer bar

Revise specification, implement thickness

measurement at RI

4 Accuracy of Calibration M

Calibration variation accounts for 20%

of overall bar temperature variation

Revise instrumentation specifications for

use during sealer calibration. Improve

instrument accuracy to 1:10 ratio


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Documenta t ionDocumenta t ion

Failure Analysis / Root Cause Analysis can be

included in:Complaints / Adverse Reactions / HCT/P DeviationsInternal Deviations (Errors, Incidents, Accidents)

Validation Failures

Inspection Failures / Non-Conforming ProductOther Corrective / Preventive Action Projects

Key Elements of Documentation

Specific Problem StatementTraceability / Tracking Information

Failures

Test Samples


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Key Elements of Documentation (cont.)Failure Investigation

Observational / Inspection Data

Test InformationProtocol

Data Analysis

Results

Conclusions

Causal Factor Identification

Hypothesis

Hypothesis Testing and Verification

Protocol

Data Analysis

Results

Conclusions

Root Cause Summary (report, table, etc.)


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Po in ts to Consid e rPo in ts to Consid e rHow detailed do I need to be in my documentation?

Detailed enough so that someone from the outside can follow your

logic and could replicate your results.

Detailed enough to meet specific regulatory requirements (i.e.

complaints, adverse reactions, HCT/P deviation)

Do some areas need to be more detailed thanothers? If so, what areas should I emphasize?

Yes:

Problem Description

Traceability


Root Cause Summary


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Po in ts to Consid e rPo in ts to Consid e rDo I have to go through every step for every investigation?

No, use common sense and right-size the activities for the project.

Wherever the term investigation is used in a regulation or standard, a certainlevel of rigor is implied. Again, focus on:

Problem Description

Traceability


Root Cause Summary

For Complaints (not reportable to FDA), when can I avoid

doing an Investigation and Root Cause Analysis?

When a similar complaint has been fully investigated and you can refer to such

an investigation.

When the event, based on documented data analysis, is an isolated event and

does not represent a trend (this does not relieve requirements for review and

evaluation for complaints related to core CGTP requirements.)


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Po in ts to Consid e rPo in ts to Consid e rWhen in doubt, write it down!

If you were an Auditor, what would you want to seeto ensure activities were done correctly?

If CAPA is done by another group or person, what

will they need to complete the project?If I were gone, would someone be able to follow my

process and reach the same conclusion?

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