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NC 1

Inconsistencia de información en Validación de Equipo

Validación de Maquina de empaque-Sellado Starview Blister (ERB8-1418 / IQ/OQ-10-


002 11/19/10), no hace mención de los dados/dibujos utilizados y/o requeridos para
ratificar conformidad con el producto validado y sus respectivos criterios de
aceptación.
Requerimiento: ISO 13485:2003 7.5.2.1 / 21 CFR part 820 QSR 820.75

NC 2

Condiciones que pudieran afectar la calidad de los materiales no están documentadas.

Areas de almacenaje de Juárez y El Paso TX, no cuentan con un proceso


documentado, en relación a condiciones de temperatura, humedad y relacionados,
que pudieran impactar la calidad de los materiales (que apliquen), tanto en materia
prima o producto terminado.

Requerimiento: ISO 13485:2003 7.5.5 / 21 CFR part 820 QSR 820.150(a)

NC 3

Regulaciones mandatorias no están claramente establecidas.

La regulación de la norma ISO 14971 de Administración del Riesgo (Risk


Management), no está mencionada en el manual de calidad QM 1.0-01 fecha de
última revisión 06/04/12), así como tampoco marca un lineamiento a seguir en el
procedimiento de validación de procesos.

Requerimiento: ISO 13485:2003 4.2.1(f) - 7.1 N3 / 21 CFR part 820 QSR 820.20(d)

NC 4

Inconsistencia de estructura de fechas en Registros.

El establecimiento de fechas en diversos registros (DHR´s, mantenimiento,


entrenamientos, etc), muestran inconsistencia de orden, en relación al mes, día y
año, no siendo clarificada cuando se describe con números solamente.

Requerimiento: ISO 13485:2003 4.2.4 / 21 CFR part 820 QSR 180

04/05/17 01/05/17 may/20/17 20/may/17


NC 5

Omisión de unidades de medida y de cantidades en registros de calidad.

Registro de inspección de calidad (Inspección y prueba - Converting) Forma F7.5.1-


01-03 SC Rev. 2 (puntos 3, 4 y 9 – En un. de parte: 39-3307, Lote: 24005) no
clarifican la unidad de medida en relación al criterio de calidad y/o especificación
requerida.
Los Certificados de calidad emitidos, no incluyen la cantidad de producto que se está
liberando.

Requerimiento: ISO 13485:2003 7.1 (c)(d) & 7.5.1.1 (b) / 21 CFR part 820 QSR 820.70(a)

NC 6

Materia prima sin identificación relacionada a su estado o condición dentro de la


empresa.

Materias primas del almacén de El Paso, TX. (Localizados a un costado de los racks)
no mostraban su estado o condición (estatus de identificación) dentro de la empresa.
No se clarifico si se encontraban en proceso de inspección, rechazado y/o liberado
para ser almacenados.

Requerimiento: ISO 13485:2003 7.5.3.3 / 21 CFR part 820 QSR 820.86

NC 7

Registro maestro de producto (DMR) incompleto.

El registro de producto DMR-03 Rev. 3, menciona el alcance de sus requerimientos a


la planta ZZZZ, como única planta que maneja la manufactura del producto,
omitiendo a la planta de Juárez, que también elabora la misma familia de productos.

Requerimiento: ISO 13485:2003 4.2.4 / 21 CFR part 820 QSR 820.181

NC 8

Inconsistencia en cancelación de espacios no utilizados en registros.

Registros de diversas areas (procesos), tales como: inspección XX, material no-
conformante YYY, mantenimiento ZZ, entrenamiento RRR, etc. No reflejan la
apropiada cancelación de espacios o secciones no utilizados, en sus formatos a ser
llenados.

Requerimiento: ISO 13485:2003 4.2.3 (g), 4.2.4 / 21 CFR part 820 QSR 820.80 (e), 820.180, 820.184

NC 9

Inconsistencia de información y/o verificación en planes y registros de las areas de


Calibración y Mantenimiento.

o Listado de equipos de calibración 2012, no cuenta con evidencia de aprobación.


o Certificados emitidos por el proveedor de calibración, no muestran evidencia de
revisión por parte del personal de ZZZZZZ o confirmación de los resultados.
o Programa de mantenimiento 2012, con cuenta con evidencia de aprobación o revisión
o Plano (layout) de control de plagas, no tiene evidencia de revisión o aprobación

Requerimiento: ISO 13485:2003 4.1(d)(f), 6.3, 7.6, / 21 CFR part 820 QSR 820.5, 820.70(g)(2), 820.72

NC 10

Proceso de revisión de efectividad del entrenamiento, no clarificado.

Procedimiento xxxxx y registros de entrenamiento xxxxx, no describen claramente la


metodología y/o actividades que se llevan a cabo, para confirmar la efectividad de los
entrenamientos impartidos (externos e internos).

Requerimiento: ISO 13485:2003 6.2.2 ( c ) / 21 CFR part 820 QSR 820.25

NC 11

Actividades de retrabajo, no acordes a procedimiento establecido.

La forma en que se documenta el retrabajo (cuando aplica – en formato F8.3-01-04


SC rev. 2), no se documenta de acuerdo a lineamientos descritos en procedimiento
8.3-01 Rev. 6. En donde la información que se muestra no clarifica la re-inspección
del material o plan de muestro a utilizar en situaciones donde se ha retrabajado algún
material o producto final.

Requerimiento: ISO 13485:2003 8.3 / 21 CFR part 820 QSR 820.90(b)(2)


NC 12

Disponibilidad de instrucciones de trabajo, no definida apropiadamente.

No está formalmente establecido, bajo qué condiciones se manejaran los


procedimientos o instrucciones de trabajo, que deberán estar disponibles en punto de
uso, así como la clarificación del control de ayudas visuales. Ejemplos: maquina
cortadora de tape, no cuenta con instrucciones sobre su manejo y control de
parámetros, proceso de empaque y liberación para lotes (envíos) pequeños (en el
Paso, TX), no está documentado, proceso de revisión de parámetros en maquinas de
converting no clarificadas.

Requerimiento: ISO 13485:2003 7.5.1.1 (b) / 21 CFR part 820 QSR 820.70(a)

Regulation / Standard / Quality Agreement Requirement not being met:

ISO 13485:2003; 7.5.2 Validation of Processes for Production and Service Provision, and 7.5.2.1 General
Requirements (a)

Description of Observation:

There is inconsistent information in the OQ requirements described in the protocol and summary reports.

Inconsistent information was found in validations in which the protocols describe the performance of OQ without
worst-case testing; however, the summary reports reviewed mention that the process/equipment has been
challenged against worst-case scenarios and results are within acceptable limits.

The following validations (whit these discrepancies) were reviewed:

 DOC0879163 performed on 23 February 2011. Process: Verification plan for infusable net cutting process MCI-
001
 DOC0755733 Rev. 2, performed on 10 December 2010. Process: Vital signs infusable RF sealing process
(rotary), area/line: infusor bags, RF sealer machine
Regulation / Standard / Quality Agreement Requirement not being met:

ISO 13485:2003; 8.2.4 Monitoring and Measurement of Product, and 8.2.4.1 General Requirements

Description of Observation:

The inspection methods are not clear in confirming the Quality criteria for the assembly component.

The Work Instructions for the assembly components between the diaphragm and the plastic pivot (Visual Aid
BOPDOC0716424 - Step E- Rev.3, 04 April 2011) show a Quality criteria dimension of 10 millimeters as maximum. However,
the Work Instructions do not describe the method or measuring device for this inspection requirement. The Quality Inspector
uses a calibrated steel ruler to review the distance, but this is not described on procedure.

Compliance
Reference

ISO Description of Finding:


13485:2003
8.2.4 There is a lack of information on quality inspection records.
Monitoring
and
Objective Evidence:
Measurement
Two inspection records (form 10023113, Rev. A and form 10017505, Rev. D on DHR Part Number
of Product
331423-A, lot 2107177, dated April 15, 2012) do not clarify the applicable AQLs used for the quality
criteria. The formats/records show several options of AQLs, but do not indicate and/or confirm what
AQLs are used for each CTQ.

Finding XX -

 Incomplete information on validations.


o CPk´s studies are not formally included on ULMA machine (OQ)
o The title of the format is the same for OQ and PQ ( ULMA Machine)
o Conclusions per validation stage (on IQs and OQs) are not included.
o Notes without revision (or justification) were added on IQ of laminated
machine validation.
o Ranges of test without unit of measure on OQ of laminated machine
validation.
o The PQ does not clarify the lot numbers using to release product on
conclusion report.

ISO 13485:2003 7.5.2.1 (a)(c)(d) / 21 CFR Part 820.75 (b)(2)


Finding XXX

 Unclear information on quality inspection records.

o The quality inspection record for part number METB 11 14 /114G (lot
11KGH737, date 10-31-11/ form CSP-207-03 Rev. 04/11 – “Reporte de
inspeccion”) does not clarify at what time the samples were taken (6:00-8:00
or 3:30-5:30 and 8:00-10:00 or 5:30-7:30) and not shown the applicable shift
(1, 2 or 3 ?).

ISO 13485:2003 8.2.4.1 / 21 CFR Part 820.80 & 820.184

Finding XXX

 Inconsistence information on inspection methods.

o The burst test procedure SIM-T-04 Rev. 04, 9/23/11 (section 5.4) not clarify the
equipment adjustment to perform the different functional test on pouches.
o Functional test (on seal of sleeves – “prueba de balin”) use a ball of metal
without calibration and/or applicable qualification, form CSP-148.02 rev.
04/10. Product # 89515220, 01/18/12.

ISO 13485:2003 7.5.1.1 (e), 7.6 (a)(b) & 8.2.4.1 / 21 CFR Part 820.70(2,3), 820.80

F1
Requirement: 8.5.2.
A documented procedure shall be established to define requirements for
f) reviewing the effectiveness of the corrective action taken.

Corrective Actions are being closed without objective evidence available to demonstrate
their implementation and effectiveness

Evidence:
Corrective Actions issued during 2010, not include the applicable evidence as form QAF-
004-005 Rev. 3 (Corrective/Preventive action evaluation & lesson learned Report ) is
requested
F2
Requirement: 8.2.2
The management responsible for the area being audited shall ensure that actions are
taken without undue delay to eliminate detected nonconformities and their causes.
Follow-up activities shall include the verification of the actions taken and the reporting of
verification results.

Findings of Internal audits are not followed up.

Evidence:
Several findings NCN’s (Non Conformity Note) have not been answered within two
weeks, as procedure QAP-17-012 Rev. 19 is requested.

Examples: NCN 10-476, 10-478, 10-453 and 10-452.

F3
Requirement: 8.2.2
An audit program shall be planned, taking into consideration the status and importance
of the processes and areas to be audited, as well as the results of previous audits.

Internal audits are not being performed in accordance to audit schedule or not have the
applicable rationale

Evidence:
Based on procedure QAP-17-012 Rev. 19, section 6.4.1.1 Internal audit schedule may be
modified and this decision will be approved by General Manager, after justification is
presented by Quality Manager. This decision will be documented in Management
Review…

The internal audits performed on April and September 2010, not match with approved
calendar and not include the applicable rationale or justification.
F4
Requirement: 5.6.2.
The input to management review shall include information on
c) process performance and product conformity,
d) status of preventive and corrective actions,

Incomplete (input) information on Management review

Evidence
a) Management review meeting minute of March 2010, does not include a
conclusion or summary about CAPA’s Status.
b) Procedure of Management audits QAP-II-II Rev. 2, section 6.3.3, request escalate
and/or evaluate these results on MR meeting. No evidence.

F1

F2
Audit Observation No. 1

Date Issued: TBD Action Plan Response Due: TBD

Supplier Name: zxxxxx Supplier Observation

Record #(s): 558977

Critical Observation Major Observation Minor Observation


Regulation / Standard / Quality Agreement Requirement not being met: ISO 9001:2008 § 7.6 ( c ) Control of Monitoring and
Measuring Devices; ISO15378:2011 section 7.6 (c)

Description of Observation:

The calibration status for in-process go/no-go gauges was inconsistently identified.

For example, metal gauges ID NA 19.010.131 and ID NA 19.007.81 (used to check glass tubing dimensions on cartridge forming
machine #210) were inconsistently identified. One side of the gauges indicated the dimension (e.g., maximum 2.99 mm &
minimum 2.81 mm). However, the reverse side on both gauges only showed the letters MAX (maximum). The calibration and
dimensions are correct, but the MAX are the same for both.

Audit Observation No. 2

Date Issued: TBD Action Plan Response Due: TBD

Supplier Name: 558978


xxxxx.

Critical Observation Major Observation Minor Observation


Regulation / Standard / Quality Agreement Requirement not being met: ISO 9001:2008 § 8.2.3 Monitoring and Measurement
of Processes; ISO15378:2011 § 8.2.3

Description of Observation:

ZZZZZ environmental control program did not clearly define required action limits. For example, The May 20xx Particulates
Report for the environmentally-controlled inspection/pre-packaging room included an established action limit (3,520,000 /
particles of 0.5 µm); however, the report did not include the required correction and corrective actions to be performed if limits
Commented [M1]: Please include the actual action limit
information.
are exceeded.
CR
Observations

Chapter 6 - Commercial Manufacturing

Quality Module 6.01 - Facilities and Equipment ID No. XXXXXX Minor

Quality System: 07 - Facilities, Utilities and Equipment

Quality Sub System: 7.03 - Calibration

Observation Description

Ensure that all calibration records are completed and reflect the correct condition of use.

A calibration program of equipment is not formally implemented as requested by procedure PNO-AC-018,


revision 02 24 May 2012. The calibration records are available; however, a formal list is not available.

Quality Module 6.01 - Facilities and Equipment ID No. XXXXXX Minor

Quality System: 07 - Facilities, Utilities and Equipment


Quality Sub System: 7.09 - Environmental Monitoring

Observation Description

Ensure that environmental controls are implemented and controlled.

Controlled rooms do not have a formal reaction/action plans if ranges of temperature or humidity are
found out of spec. Based on procedures PNO-AC-005, revision 01, 18 April 2011 and PNO-AC-012, revision
02, 01 July 2012, the range of temperature is from 19.5 to 25 C; the range for humidity is not exceeding
60%.

Quality Module 6.01 - Facilities and Equipment ID No. XXXXXX Minor

Quality System: 07 - Facilities, Utilities and Equipment

Quality Sub System: 7.16 - Preventive Maintenance

Observation Description

Ensure that all maintenance and pest control activities are formally documented.
Maintenance activities are not clearly documented when are performed by an external service provider.
The blister sealer machine and oven receive preventive maintenance that is not documented.

The controls of flying insect lamp locations are not included on the current layout of pest control F-PL-S-
001. Lamps are physically implemented in several areas of the facility, but the layout does not describe
these locations.

Quality Module 6.07 - Process Validation ID No. XXXXXX Minor

Observation Description

Ensure that the organization validates any processes for production and service provisions where the
resulting output cannot be verified by subsequent monitoring or measurement.

Validations of machines/equipment are not clearly described on the current procedure PNO-AC-016,
revision 01, 01 July 2011, when these validations are performed by an external service provider. The blister
sealing machine, shrink wrap machine, and oven band, among others, have been validated by the supplier;
however, the results are not available with XXXXX personnel.