Documentos de Académico
Documentos de Profesional
Documentos de Cultura
NC 2
NC 3
Requerimiento: ISO 13485:2003 4.2.1(f) - 7.1 N3 / 21 CFR part 820 QSR 820.20(d)
NC 4
Requerimiento: ISO 13485:2003 7.1 (c)(d) & 7.5.1.1 (b) / 21 CFR part 820 QSR 820.70(a)
NC 6
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.
NC 7
NC 8
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
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
NC 11
Requerimiento: ISO 13485:2003 7.5.1.1 (b) / 21 CFR part 820 QSR 820.70(a)
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.
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
Finding XX -
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 ?).
Finding XXX
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.
Evidence:
Several findings NCN’s (Non Conformity Note) have not been answered within two
weeks, as procedure QAP-17-012 Rev. 19 is requested.
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,
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
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.
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
Observation Description
Ensure that all calibration records are completed and reflect the correct condition of use.
Observation Description
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%.
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.
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.