vahey getting to root cause during your capa ... - fdanews

QUALITY BEGINS WITH ME

FAILURE INVESTIGATION “Treating the root cause, not the symptoms”

PRESENTED BY Karl Vahey Senior Director Manufacturing Quality, Europe and Asia Medtronic

2 Failure Investigation | June 1, 2015 | Confidential, for Internal Use Only

AGENDA

Importance of failure investigation. Why?

Industry performance

Failure Investigation steps

Investigation Tools & Examples

Good Investigation Practices

Lessons learned


WHY?

Let us paraphrase

• 21 C.F.R. 820.90, Nonconforming product

• 21 C.F.R. 820.100, Corrective and Preventive Action

• 21 C.F.R. 820.198, Complaint Files

“LEGAL….YOU HAVE TO!”


WHY?

21 C.F.R. 820.90, Nonconforming product

• Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements. The procedure shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming products. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented.


WHY?

21 C.F.R. 820.100, Corrective and Preventive Action

• Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedure shall include requirements for :

(2) Investigating the cause of non conformities relating to product, processes and the quality system.

21 C.F.R. 820.198 (b), Complaint Files

• Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate


WHY?

21 C.F.R. 820.198 (c), Complaint Files

• Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated and investigated

21 C.F.R. 820.198 (d), Complaint Files

• Any complaint that represents an event which must be reported to FDA under part 803 of this chapter shall be promptly reviewed, evaluated, and investigated by a designated individual……..


WHY?

21 C.F.R. 820.198 (e), Complaint Files

• When an investigation is made under this section, a record of the investigation shall be maintained by the formally designated unit identified in paragraph (a) of this section. The record of investigation shall include:

(1) The name of the device

(2) The date the complaint was received

(3) Any device identification(s) and control number(s) used

(4) The name, address and phone number of the complainant

(5) The nature and details of the complaint

(6) The dates and the results of the investigation

(7) Any corrective action taken and

(8) Any reply to the complainant


WHY?

Our Customers Expect

• Safe, Reliable & Effective Products

The FDA requires:

• Implementation & compliance to procedures

• Thorough investigations & testing commensurate with event &

potential impact

• Implementation & Effectiveness of all Corrective / Preventive Actions

• Review & Disposition of investigations


WHY?

Good Business Practice

• Scrap reduction

• Rework reduction

• Cost of Quality reduction

• Process improvements

• Elimination of recurring issues


WHY?

Patient Safety


FDA 2014 Top 10 483 Findings (FDA WEBSITE)

0

100

200

300

400

500

600

820.30 820.100 820.198 820.90 820.20 820.22 820.70 820.75 820.40 820.80

515

475 456

211

191 186

180 175 158

156

Observation


FDA Warning Letters With CAPA Cite (FDA WEBSITE )

Year Warning Letters (WL)

Issued WL with CAPA citation %

2003 69 61 88%

2004 113 89 79%

2005 97 85 88%

2006 79 69 87%

2007 74 62 84%

2008 98 86 88%

2009 77 68 88%

2010 89 81 91%

2011 122 104 85%

2012 164 143 87%

2013 144 127 88%

2014 121 109 90%


How Is Industry Performing ?

FDA observations indicate

1. Inadequate investigations

2. Lack of investigation

3. Failure to determine true root cause

4. Inadequate Corrective and Preventive Action

5. Lack of documentation


Warning Letter Examples

Failure to record the dates and results of complaint investigations, as required by 21 C.F.R. 820.198(e)(6)

Specifically, four of the six complaints received since January of 2006 did not have documented failure investigations, including the individual performing the investigation and the date it was performed

2. Failure to ensure that complaints involving the possible failure of a device, labelling, or packaging to meet any of it’s specifications were reviewed, evaluated, and investigated, as required by 21 C.F.R. 820.198(c), and failure to ensure that the record of the investigation included the dates and results of the investigation and any corrective action taken as required by 21 C.F.R. 820.198(c)(6)-(7)

For example:

Your firm evaluated complaints and confirmed that the device malfunctioned. However, your firm did not investigate the root cause of the malfunctions for the following complaints……..



Failure to establish and maintain adequate procedures for investigating the cause of nonconformities relating to product, processes, and the quality system as required by 21 C.F.R. 820.100(a)(2); for identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems as required by 21 C.F.R. 820.100(a)(3); for implementing and recording changes needed to correct and prevent recurrence of nonconforming product and other quality problems as required by 21 C.F.R. 820.100(a)(5); and for ensuring that information relating to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems, as required by 21 C.F.R. 820.100(a)(6)

a. Specifically, your firm has not investigated and documented why 115 devices did not cool and their global board chips were replaced during the production period from 3/24/08 to 7/17/08, and implemented adequate corrective action. Two of the devices had the same chip replaced five times. There was no documentation that this quality issue was addressed with the manufacturer of the circuit boards or your employees



Failure to investigate the cause of nonconformities relating to the product, processes, and the quality system, as required by 21 CFR820.100(a)(2). Specifically, the Medical Device Return Merchandise Authorization (RMA) Log documents that fifty-five RMA’s have been issued between 10/4/07 and 9/10/08. Of these fifty-five, about 18 specify the reason for return as 'warranty evaluation", 10 specify ‘will not charge’. There is little or no documentation to show that the causes of these non-conformities were investigated.

5. Failure to investigate complaints involving the possible failure of a device to meet any of its specifications as required by 21 CFR 820.198(c). For example, no investigation was conducted for the following XXXX systems that were returned after apparent device failures:

• Complaints #345, 378, 389, 397 and 432 - inaccurate measurements

• Complaints #337 and 366 - incorrect data storage

• Complaint #354 - irregular pressure recording

• Complaints #323 and 424 - cuffs not inflating

• Complaints #330 and 350 - not functioning



Failure to review and evaluate, and investigate where necessary complaints involving the possible failure of a device to meet any of its specifications, as required by 21 CFR 820.198 (b).

Specifically, during the review of the complaint records, several reports were encountered involving the possible failure of a device to meet its specifications, and for which your firm decided that no investigation was necessary; the only justification provided was “not of interest.”

For example:

a. A complaint was received on December 11, 2007, for a Magnetic Pull-Cord Alarm, which stated 3 alarms from the case did not work, the documented evaluation stated “DID NOT INSPECT Alarms did not work NOT OF INTEREST.”

a. A complaint received on November 7, 2007, for a Sit-Straight Cushion with a TR2 alarm stated there was a short in the alarm connection to the cushion. The evaluation stated “NOT OF INTEREST DO NOT INSPECT.”



Failure to establish and maintain adequate procedures for the information that must be documented in a record of the investigation , as required by 21 CFR. 820. 198(e).

For example:

a. The following complaints are incomplete and do not include an investigation plan, investigation results, investigation updates or the identification or implementation of corrections or corrective actions:

i. Compliant 1314915 was opened on November 16, 2007, because a customer on XXXXXXXX stated that CT exam reports were being assigned to incorrect exams. On 1/9/08, the complaint evaluation risk assessment resulted in an R2 rating (Product Safety issue) and a work around was created for the customer. The CAPA Review Board reviewed the issue March 7, 2008, and decided a CAPA was not necessary. An investigation to identify root cause was not conducted until information about the complaint investigation was requested during this inspection. Information provided on 5/1/08 revealed that a fix for this issue was made in April 2005. Mandatory Safety Field Modification Instruction (FMI) 85122 was created on 5/12/08 for this issue.



Failure to investigate the cause of nonconformities and identify corrective actions needed to prevent recurrence of non-conforming product relating to product processes and the quality system, as required by 21 C.F.R. § 820.100(a)(2) and (3). Specifically,

The injection molding scrap rate for 14FR Balloon for lot #10090947 is 46%; lot #10091334 is 44%; and lot #10091337 is 38%. The reason listed for the rejection of all these balloons is “thin spots”. Your firm has not conducted an investigation to determine the cause of these nonconformities and no corrective action has been taken.


Warning Letter Examples Failure to establish procedures for corrective and preventive action, as required by 21 CFR

820.100(a). Specifically, your procedures for corrective and preventative actions (CAPA) do not ensure adequate investigation of the cause of nonconformities relating to product; identify the action(s) needed to correct and prevent recurrence of nonconforming product; and ensure via verification or validation that the corrective and preventive action is effective and does not adversely affect the finished device as evidenced by the following examples noted upon review of CAPA #69:

b) Your firm’s CAPA actions do not adequately investigate root cause of the nonconformity. Your firm concluded the root cause for contamination in the raw material, Santicizer (b)(4), as being a rust-like material present from decomposition of the drum holding Santicizer #(b)(4) lot number (b)(4), as confirmed by laboratory analysis. Your firm’s CAPA investigation did not review and evaluate additional lots of raw material Santicizer #(b)(4) in similar drums to ensure all affected drums/lots were identified. Your firm’s CAPA investigation did not determine whether the contamination identified in the raw material Santicizer #(b)(4) is also the same contamination identified in your bulk Impak Elastic Acrylic Resin Liquid CMP part #(b)(4). Your firm’s CAPA investigation failed to include review of Complaint 538 for Impak Elastic Acrylic Resin Liquid lot number (b)(4) that alleges “rust like specks in liquid” to determine if the complaint was related to the issue under investigation. Your firm concluded this complaint was a result of fiber like material contamination without any compositional or physical testing to support the complaint conclusion.



Failure to adequately establish procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).

Specifically, SOP QS-2024 (Rev. 6.0, “Nonconforming Products or Equipment”) fails to require any documented evaluation and/or investigation from the vendors or suppliers of non-conforming materials. The procedure also fails to include a requirement to document any re-work that may have been performed on components or the finished device in the DHR. NCMR #QS-73259 identifies (b)(4)circuit boards (Part Number (b)(4)) as non-conforming (b)(4). The non-conforming circuit boards were returned to the supplier, re-worked, and returned to the manufacturer where they were re-inspected, accepted, and returned to stock. There was no documented request to the supplier for investigation related to the non-conforming circuit boards. Further, the re-worked circuit boards are uniquely identified by serial number; however, the re-worked circuit boards were used in the manufacture of the Merge Hemodynamics devices without any documentation of the serial numbers in the respective DHRs.



3. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).

Your firm did not follow its “Corrective Action Preventive Action”, procedure Revision 1 dated May 22, 2013, requiring your firm to perform and document investigations of corrective and preventive actions (CAPA), and verification that corrective actions taken were effective. For example,

a. CAPA (b)(4) dated December 30, 2013 was initiated to address a finding that your devices risk management report incorrectly identified labeling as a mitigation of risk, which your firm identified was not in compliance with a standard ((b)(4)) followed by your firm. The CAPA states the risk management report will be updated; however, there is no record your firm verified this correction was completed. In addition, there is no investigation to confirm the causes for the deficiencies or systemic corrections to correct this nonconformance.


Industry Trends

SO WHY IS THIS HAPPENING?

Inaccurate problem statement

• Symptoms are addressed but not the actual problem • The quick fix!

Incomplete/Lack of a documented investigation

• Root cause not established

Inadequate/ incomplete effectiveness checks

Timeliness


Failure Investigation

Key components

1. Problem Statement

How, what, when, where, why, who?

Review of data/facts for similar occurrences e.g., complaints, batch records, engineering files, etc.

Determine the scope of problem (i.e., plant, division, facility, shift, machine, product code)

2. Containment, correction, assess Risk

3. Identify root cause

4. Identify & implement Corrective & Preventive Actions

5. Effectiveness verification


Failure Investigation

Ask

What is known? What data/facts are needed? What tools should be used? What is the sense of urgency? What is the timeline for resolution?

Consider ♦ Any similar events reported or

known?

♦ Complaints, Repairs, Trend

Reports

♦ Across Corporation – Globally

♦ Does the problem affect:

– Other products?

– Other processes?

– Other facilities?

– Other suppliers or

manufacturers?


Identify Problem Statement

“The formulation of a problem is the most essential part of problem solving”

Albert Einstein


Problem Statement

What is a ‘problem’?

When what happened is different than what should have happened

What is a problem statement? Concise, yet complete definition of a problem.

Why is a problem statement important? Necessary for the investigation

Clearly identifies & describes the problem you are trying to solve

Avoids guesswork


Example

Complaints have been received indicating an issue with Pulse Oximeters.

Complaint trends indicate that there is an issue with audio failures on Pulse Oximeters.

The complaint data from Jan 2005 to October 2006 demonstrates a trend in audio failures related to the main PCB board, PN 56983, of the X2312 Pulse

Oximeters.


2. Assess Risk

Patient Risk Assessment

• Health Hazard Evaluation (HHE) to evaluate field (post market) product performance; evaluate hazards and score health hazards based on likelihood of occurrence, probability of injury, and severity of injury.

• Consult with Medical Practitioner

Decide on Product CONTAINMENT


3. Root Cause Analysis

The identifiable factor(s), based on objective evidence, which has (have) been determined to be

responsible for the nonconformity, trend, or aberrant or unexpected result.


Root Cause Analysis (Continued)

Root cause traps Equipment failure

• “It just broke”

Human error

• Procedure is inaccurate, training is current, the employee

made a mistake



Take a Broad Investigation Perspective

• Any similar events reported or known?

• Complaints / NCMRs / Repairs / Trend reports

Evaluate IMPACT on:

• Other lots / product already distributed

• Other products

• Other processes

• Other facilities

• Quality System

Other suppliers or manufacturers



Investigation Tools & Examples

a) FTA (Fault Tree Analysis)

b) Failure Mode and Effects Analysis (FMEA)

c) Cause & Effect and Fishbone technique

d) 5 WHYs


A) Fault Tree Analysis

Undesired state of a system ( top event) is analyzed using Boolean logic

Visually models logical relationships between:

equipment failures,

human errors,

and external events

Can combine to cause specific non-conformances

A more sophisticated form of the 5 Whys


Fault Tree Analysis (Example)

Bulb Fails

No electricity

Power Plant Fails

Power Line Fails

Glass Broken

Filament Broken

Connector Corroded

Vacuum Leak

Tree Breaks Line

Wind Breaks Line

Impurities Vibrations


B) Failure Mode and Effect Analysis

Brainstorm potential failure modes

List potential effects of each failure mode

Assign a severity rating for each effect

Assign an occurrence rating for each failure mode

Assign a detection rating for each failure mode and/or effect

Calculate the risk priority number for each effect

Prioritize the failure modes for action

Take action to eliminate or reduce the high-risk failure modes

Calculate the resulting risk priority number (RPN) as the failure modes are reduced or eliminated


C) CAUSE AND EFFECT DIAGRAM (ISHIKAWA)

Method Measurement Machine

Environment People

Larger ‘Bones’ give main possible cause

Smaller ‘Bones’ give root cause

Head of the fish is the focused

problem


D) 5 Why Analysis

Ask the 5 WHY questions to find the root cause of the problem

• 1. Ask - Why did the problem occur

• 2. Ask - Why did 1 cause the problem




This should provide the true root cause


5 Why Example

Problem Statement: You are on your way home from work and your car stops in the middle of the road.

1. Why did your car stop? - Because it ran out of gas.

2. Why did it run out of gas? - Because I didn't buy any gas on my way to work.

3. Why didn't you buy any gas this morning? - Because I didn't have any money.

4. Why didn't you have any money? - Because I lost it all last night in a poker game.

5. Why did you lose your money in last night's poker game? - Because I'm not very good at "bluffing" when I don't have a good hand.


5) Identify & Implement CAPA

Record investigation & identify root cause

Identify & agree actions

Identify product quality impact on taking agreed actions

Document the planned method of effectiveness for the agreed actions

Implement actions

Approve completion of actions

Perform Effectiveness checks

Evaluate & Close CAPA


Good Investigation Practices

Good Executive Summary: • Clear & succinct Problem Statement

• Description of the depth of the problem

• Risk level assessed (significant or minor)

• Identification of key team members & leader

• Brief chronology of significant events in the investigation

• Actions and conclusions that are supported by facts


Failure Investigation – Lessons Learned

- Stopping too soon in the process

- Not asking the why enough times-not getting to the true root cause

- Incomplete investigation

- Factors not considered / documented

- Associated lots not identified / evaluated

- Absence of root cause not justified

- Conclusions not supported by data


Failure Investigation – Lessons Learned

- Jumping to quick conclusions

- Does the investigation file contain opinions, assumptions, and

guesses?

- Not having the “right” people involved

- DOCUMENTATION!


Conclusion

Ensure:

• Accurate problem statement

• Complete and documented investigation

• True root cause

• Adequate effectiveness checks


?????Any Questions?????

vahey getting to root cause during your capa ... - fdanews

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