Document: F-C200027 ECN: 46376

CAPA Investigation
Revision: E Effective: See EDMS

Section 1 – To be completed by the Investigation Phase Owner

CAPA # / Priority Assigned
000208 / Corrective Investigation Phase Owner Elisa Chaves
(from CAPA Request Form)
CAPA Due Date (from CAPA
Current Date 17-Jul-23 31-Oct-2023
Request Form)
Investigation Results (Document, as applicable, scope/breadth of the issue, including other products/processes/documentation
affected, Impact/disposition of any affected product, including in stock, in-process and product already delivered, interview(s)
conducted, data reviewed, LHT review, etc.)
Summary of Results

An investigation and evaluation for this event was performed and it was requested MCI to execute microbial species identification
using MALDI-TOF analysis.

The bacterial identification results obtained by MCI indicated follow:

Therefore, according to the results obtained with the bacterial identification is demonstrated that there is a higher concentration of
human-dwelling bacteria making their way onto cleanroom surfaces.

The results out of specification detected during the monthly Environmental Monitoring are directly related with the personnel that
work/enter inside the cleanroom and with the cleanroom gowning and PPE practices.

Root Cause / Probable Root Cause Analysis and Results (Provide a description or attach the root cause analysis, fish bone diagram, 5
whys, process mapping, gaps analysis, etc.)
Root Cause Analysis

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 Document: F-C200027 ECN: 46376
CAPA Investigation
Revision: E Effective: See EDMS

The probable root causes were analyzed in the following Ishikawa Diagram:

Mano de
Material Método obra/Humano

Use of non-sterile gloves. Line clearance procedure was not followed.

No alcohol bottles at all workstations.

Not adequate clean room cleaning frequency.

The coat is placed outside the gowning.

Lack of instructions about how to clean the areas.

The monitoring monthly

results for Viable particles
on surfaces were out of
specification.

Not adequate 5's in areas and workstations.

N/A

N/A

Medio Ambiente Medición Máquina/Fixture

Figure #1: Cause and effect diagram

Material
 Use of non-sterile gloves: Use gloves are required to enter in the cleanroom, the procedure WI-R200001 rev. B indicate as follow:

Figure #2: Procedure WI-R200001

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 Document: F-C200027 ECN: 46376
CAPA Investigation
Revision: E Effective: See EDMS

The procedure is not specific about which kind of gloves (sterile or not sterile) should be used but a note indicates that gloves
must be changed when they become damaged or contaminated.

 No alcohol bottles at all workstations: The procedure WI-B072305 “Cleanroom Cleaning and Maintenance” rev. M indicate the use
of 70/30 Isopropyl alcohol solution to clean surfaces and fixturing:

Figure #3: Procedure WI-B072305

However, all areas were inspected, and it was identified that not all workstations have their own alcohol bottles, the cleanroom
personnel must share the alcohol bottles when the areas are cleaned.

Method
 Not adequate clean room cleaning frequency: The procedure WI-B072305 “Cleanroom Cleaning and Maintenance” rev. M
indicates the requirements for cleaning and maintenance of the cleanroom:
 Daily/weekly cleaning performed by cleanroom personnel includes the cleaning of the work surfaces and fixturing, trash
removal, the cleanroom floor (dry mop), remove the tacky mats, clean all the dirty areas, and verify the room pressure.
 Weekly cleaning performed by maintenance personnel includes cleaning the cleanroom floor with wet mops, cleaning all
the dirty areas, removing the tacky mats, wiping down the gowning room and cleaning interior walls of cleanroom.

The procedure is clear about the requirements and frequency for cleaning and maintenance of the cleanroom, and it is specific
about what to do and the responsible for each section, nevertheless, considering that the quantity of occupancy inside the
cleanroom have been increased in the las 3 years as follow:
Table #1: Cleanroom occupancy in the last 3 years.
Year Occupancy

2021

2022

2023

Therefore, is determined that the quantity of people in transit inside the clean room increased and this is direct related with the

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 Document: F-C200027 ECN: 46376
CAPA Investigation
Revision: E Effective: See EDMS

higher concentration of human-dwelling bacteria making their way onto cleanroom surfaces.

The weekly cleaning for the cleanroom floor with wet mop and the cleaning of the interior walls of cleanroom is not enough to
maintain the particles concentration under control.

 The cleanroom is placed outside the clean gowning area: The procedure WI-R200001 rev.B “Gowning and Cleanroom Procedure”
indicates the approved process to change the cleanroom clothing and the section 5.6.2.6 specify that the cleanroom gown must
be placed before the shoe covers.

Figure #4: Procedure WI-R200001

 Lack of instructions about how to clean the areas: The procedure is clear about the requirements and frequency for cleaning and
maintenance of the cleanroom, and it is specific about what to do and the responsible for each section,

People
 Line clearance procedure was not followed: The line clearance process is described in document WI-B072307 step 1 and step
4 point 4.1 to 4.6. The instructions for line clearance are clear, they describe the line clearance process step by step to avoid
material mixtures, so this possible cause is ruled out.

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 Document: F-C200027 ECN: 46376
CAPA Investigation
Revision: E Effective: See EDMS

It is concluded the root cause for this failure is Method: The quantity of people in transit inside the clean room increased and this is
directly related with the higher concentration of human-dwelling bacteria making their way onto cleanroom surfaces.

The weekly cleaning for the cleanroom floor with wet mop and the cleaning of the interior walls of cleanroom is not enough to
maintain the particles concentration under control.

Risk Assessment (A review of any applicable Risk Management documentation shall be conducted to determine if any risks associated
with the issue have been adequately documented or if documentation requires revision.)
Risk Assessment Summary

Proposed Correction(s)
Planned Tasks (Identify the tasks/actions required to eliminate and correct the issue at hand.)
Note – Actions to be taken must be in proportion to the effects / risks associated with the non-conformity / potential non-conformity.
Note – Rows can be deleted or added, as needed.
Note – Identify any documentation that needs to be updated including but not limited to Risk Management documentation)
Id Task Description

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 Document: F-C200027 ECN: 46376
CAPA Investigation
Revision: E Effective: See EDMS

1 Retrained all the personal in good manufacturing practices inside the cleanroom.
2
3
Proposed Corrective Action(s) and/or Preventive Action(s)
Planned Tasks (Identify the tasks/actions required to eliminate the cause of the issue and/or prevent nonconformance/recurrence.)
Note – Actions to be taken must be in proportion to the effects / risks associated with the non-conformity / potential non-conformity.
Note – Rows can be deleted or added, as needed.
Note – Identify any documentation that needs to be updated including but not limited to Risk Management documentation)
Id CA or PA Task Description
Increased the weekly cleaning for the cleanroom floor with wet mop and the cleaning of the interior walls of
1 CA
cleanroom.
2
3
Comments (This field is optional and can be left blank if there are no additional comments.)

Proposed Effectiveness Verification/Validation Activities

Methods & activities needed to ensure the following:
1) Actions taken are effective.
2) Actions do not adversely affect the ability to meet applicable regulatory requirement or the safety & performance of the
medical device.

Plan Completed By: Type or Printed Name Signature Date

Investigation Phase Owner
Section 2 – To be completed by CAPA Board
Title Type or Printed Name Signature Date

Quality Assurance
Engineering
Operations
Supply Chain/Materials
Other
Implementation Phase Owner Assignment (type or print
name):
Reason for Rejection / Required Additional actions
N/A (Select if CAPA is approved and this section is not applicable)

Section 3 – To be completed by the Implementation Phase Owner

Signature Date:
(acknowledgement of assignment):

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Document: F-C200027 ECN: 46376
CAPA Investigation
Revision: E Effective: See EDMS

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 Documento: F-C200027 ECN: 46376
Investigación de Acción
Revisión: E Entrada en vigencia:
correctiva y preventiva
Ver EDMS

Sección 1. A completar por el propietario de la fase de investigación

N.° de CAPA/Prioridad
Propietario de la fase de
asignada (del formulario de /
investigación
solicitud de CAPA)
Fecha límite del CAPA (del
Fecha actual
formulario de solicitud de CAPA)
Resultados de la investigación [documente, según corresponda, el alcance/la amplitud del asunto, incluidos otros productos/procesos/
documentación afectada, el impacto/la disposición de todo producto afectado, incluidos los productos en stock, en proceso y los
productos ya entregados, las entrevistas llevadas a cabo, los datos revisados, la revisión de los documentos guía de antecedentes del
lote (Lot History Travelers, LHT), etc.]
Resumen de los resultados

Causa raíz/Análisis de la causa raíz probable y resultados (proporcione una descripción o adjunte el análisis de causa raíz, el diagrama
de espina de pescado, los cinco porqués, el mapeo de procesos, el análisis de diferencias, etc.)
Análisis de causa raíz

Evaluación de riesgos (se deberá realizar una revisión de toda documentación de gestión de riesgos aplicable para determinar si
cualquiera de los riesgos asociados con el asunto han sido documentados de forma adecuada o si la documentación requiere revisión).
Resumen de evaluación de riesgos

Corrección(es) propuesta(s)
Tareas planificadas (identifique las tareas/acciones requeridas para eliminar y corregir el asunto en cuestión).
Nota: Las acciones que se tomen deben ser proporcionales a los efectos/riesgos asociados con el incumplimiento/posible incumplimiento.
Nota: Se pueden eliminar o agregar más filas según sea necesario.
Nota: Identifique toda documentación que necesite actualizarse, incluida, entre otras, la documentación de gestión de riesgos.
Id Descripción de la tarea
1
2
3
Acción/es correctiva o acción/es preventivas propuesta(s)
Tareas planificadas (identifique las tareas/acciones requeridas para eliminar la causa del asunto o prevenir el incumplimiento/la
recurrencia).
Nota: Las acciones que se tomen deben ser proporcionales a los efectos/riesgos asociados con el incumplimiento/posible incumplimiento.
Nota: Se pueden eliminar o agregar más filas según sea necesario.
Nota: Identifique toda documentación que necesite actualizarse, incluida, entre otras, la documentación de gestión de riesgos.
Id CA o PA Descripción de la tarea
1
2
3
Comentarios (este campo es opcional y puede dejarse en blanco si no hay comentarios adicionales).

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 Documento: F-C200027 ECN: 46376
Investigación de Acción
Revisión: E Entrada en vigencia:
correctiva y preventiva
Ver EDMS

Actividades de verificación/validación de eficacia propuestas

Métodos y actividades necesarias para asegurar lo siguiente:
1) Las acciones que se tomaron son eficaces.
2) Las acciones no afectan de manera adversa la capacidad de cumplir con los requisitos reglamentarios aplicables o la
seguridad y el rendimiento del producto médico.

Nombre impreso o en
Plan realizado por: Firma Fecha
imprenta
Propietario de la fase de investigación
Sección 2. A completar por la junta de la CAPA
Nombre impreso o en Firma
Título Fecha
imprenta
Aseguramiento de Calidad
Ingeniería
Operaciones
Cadena de Suministro/Materiales
Otro

Asignación del propietario de la fase de implementación (nombre

impreso o en imprenta):

Motivo del rechazo/acciones adicionales requeridas

N/A (seleccione si la CAPA está aprobada y está sección no es aplicable)

Sección 3. A completar por el propietario de la fase de implementación

Firma Fecha:
(acuse de recibo de la asignación):

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