LO QUE DEBEMOS SABER DE LAS AUDITORÍAS REMOTAS PARA LABORATORIOS
El 2020 sorprendió al mundo con una pandemia, aunque no es la primera vez que la humanidad ha vivido y superado una situación sanitaria de este tipo, si es la primera vez que los sistemas de gestión se enfrentan a los desafíos de mantener el ciclo de mejora continua en una situación tan grande como esta. Uno de estos desafíos es la continuidad en la realización de auditorías internas y externas. En este artículo presentaré como aplicar algunas consideraciones para realizar auditorías remotas de forma efectiva en laboratorios, compartiré algunas situaciones comunes entre los auditores y auditados en la realización de este tipo de auditorías y acciones recomendadas para aplicar auditorías remotas.
Los laboratorios de ensayo y calibración basan sus sistemas de gestión de calidad en la norma ISO/IEC 17025:2017, para asegurar que el laboratorio tiene implementado un sistema de gestión conforme a los requisitos de dicha norma, es necesario realizar auditorías internas en intervalos planificados. El intervalo es definido por el laboratorio y para estar acreditado debe cumplir requisitos adicionales del ente acreditador, que en al caso de Guatemala, la Oficina Guatemalteca de Acreditación -OGA- en el documento OGA-GEC-006 revisión 8, indica que las auditorías internas se deben llevar a cabo al menos cada 12 meses. Si el laboratorio ya cuenta con una acreditación vigente otorgado por un organismo de acreditación -OA-, también tiene un plazo de tiempo para realizar auditorías de seguimiento o de reacreditación, en ambos casos este plazo se está viendo comprometido por las restricciones y limitaciones aplicadas a las personas y a las organizaciones para reducir el contagio del SARS-CoV-2 causante del COVID-19.
Las restricciones que los laboratorios deben cumplir pueden ser definidas por sus gobiernos, por las políticas y lineamiento de la compañía o institución a la cual pertenecen y por decisión de la dirección del laboratorio en función los resultados de las evaluaciones de riesgo realizadas. Entre las restricciones o limitaciones más comunes podemos ver un amplio rango desde la prohibición completa de operación de industrias y servicios, la prohibición de movilidad de personas en horarios y entre regiones determinadas, hasta el cumplimiento de mínimos requisitos de higiene y distanciamiento social. Es importante mencionar otra limitación importante como lo es el cierre de fronteras, ya que en muchos casos las OAs se apoyan en expertos técnicos y auditores extranjeros para evaluar ensayos y calibraciones para los cuales no se cuenta con auditores nacionales apropiados.
En este artículo abordaremos el escenario en donde se tiene permitido la operación de laboratorio, con reducción de horario laboral por disposición del gobierno y con reducción de personal que realiza actividades presenciales en el laboratorio debido a factores de riesgo del personal.
DECIDIR REALIZAR AUDITORÍA REMOTA
En el caso de auditorías internas la persona que gestiona el programa de auditorías y la dirección deben decidir sobre la mantener o reprogramar las actividades de auditoría, esta decisión se debe considerar lo siguiente:
- Posibilidad de reprogramar la auditoría para meses posteriores, en donde sea posible y seguro la realización de auditorías presenciales. En los casos en donde la auditoría este programada en el límite del plazo que estipula la OA como requisito, reprogramarla fuera del plazo implicaría una no conformidad con dicho requisito. Con la excepción que la OA defina una ampliación o exención de dicho requisito, lo cual abordaremos más adelante en este artículo.
- Disponibilidad de recursos para adaptar el procedimiento de auditorías presenciales a auditorías remotas. Lo cual puede implicar modificar procedimientos documentados, capacitar al personal, revisar competencias del equipo evaluador y asegurar canales de comunicación digital efectivos y que aseguren la confidencialidad de la información.
- El acceso a documentación y registros en formato digital, en casos donde el laboratorio tiene un sistema de documentación y registros mixtos que incluye formatos que son registrados tanto en formato digital como a mano, se tiene que evaluar la cantidad de documentos y registros impresos y llenados a mano que sean necesarios digitalizar y compartir al auditor, si lo solicita.
Ampliando la opción de reprogramar la auditoría, se debe considerar que las OAs deben aplicar los lineamientos del Foro Internacional de Acreditación -IAF- y la Cooperación Internacional de Acreditación de Laboratorios -ILAC-. En el “Documento informativo de IAF para la gestión de eventos o circunstancias extraordinarias que afecten a OAs, OCs y Organismos de certificación”, publicado en 2011 define una serie de condiciones que de ser satisfechas permiten que las actividades normales de evaluación de la conformidad programadas se pueden posponer por hasta 6 meses, y la validez de todas las salidas de la actividad de evaluación de la conformidad, como un certificado, se puede extender la vigencia por un periodo correspondiente de hasta 6 meses. El escenario planteado para este artículo, la OA si está en condiciones de realizar actividades de evaluación y decide reemplazar las auditorías presenciales por actividades de evaluación de acuerdo con el IAF ID 12 “Principios de Auditorías remotas”. Por lo tanto, continúan las actividades normales de evaluación de la conformidad y no se justifica posponer lo programado.
PREPARACIÓN DE AUDITORÍA REMOTA
El concepto de auditoría remota no es nuevo y ha sido incluido desde la versión anterior de la norma ISO 19011 “Directrices para la auditoría de sistemas de gestión” en ella se describe a la auditoría remota con interacción humana como aquella que se realiza a través de medios de comunicación interactiva, por medio de entrevistas, observación, revisión de documentos, registros y uso de cuestionarios. En esta modalidad existe participación del auditado y el auditor a pesar de no estar físicamente en el mismo lugar.
Es importante entender que el éxito de una auditoría remota depende de comprender que, aunque el objetivo de la auditoría es el mismo, no podemos pretender que se realice exactamente de la misma forma que una auditoría presencial, así como en educación esta claro que la enseñanza de forma remota implica cambios en los métodos didácticos, en auditoría ocurre lo mismo.
Esta adaptación de los métodos de auditoría requiere competencias adicionales en los miembros del equipo auditor, estas competencias adicionales implican el conocimiento del uso y funcionamiento de los sistemas de gestión de la información del laboratorio -LIMS-, habilidades relacionadas al uso de tecnologías interactivas, habilidades de comunicación por medios digitales, conocimientos en seguridad informática para protección de la información del auditado, entre otras.
Por otra parte, los auditados preparan el acceso de los auditores a la documentación y registros de forma virtual, esto ha llevado a debate sobre si el laboratorio debe trasladar toda la información impresa y registrada a mano a un archivo digital utilizando un escáner o cámara. La decisión dependerá del auditor líder y se debe fundamentar en las competencias del equipo auditor, los principios de auditoría y las directrices de la OA cuando apliquen; es importante informar con suficiente anticipación a los auditados.
Los laboratorios deben informar a los auditores sobre sus políticas y procedimientos para la protección de la información y como sus documentos y registros deben ser resguardadas en todo momento durante la auditoría, ya que pueden dar lugar a acceso no autorizado a información confidencial del laboratorio o sus clientes. Actualmente existen diversas opciones para compartir información de forma segura, utilizando vínculos temporales a la información con contraseña, que además permiten dar trazabilidad del acceso o modificación de la información. Es preferible evitar compartir registros y documentos por correo electrónico, unidades de disco externas, mensajería de texto u otras formas menos seguras.
Siguiendo los lineamientos de IAF, es necesario determinar que plataforma se utilizará para la facilitar la auditoría remota, en la actualidad existen diversas opciones como WebEx, Microsoft Teams, Zoom, entre otras. La definición de la plataforma debería ser en consenso entre auditados y auditores, tomando en cuenta si son plataformas que pueden ser utilizadas en teléfonos móviles que faciliten realizar transmisiones de realización de ensayos o calibraciones y temas de seguridad de la información.
Es importante establecer un plan de auditoría realista, en un marco de tiempo establecido, que no debería extenderse más del doble del tiempo que se utilizaría para una auditoría presencial. El tiempo de auditoría debe considerarse con mucho cuidado, suficiente para obtener la evidencia de auditoría necesaria para generar hallazgos, evitando una auditoría excesivamente larga que disminuya la confianza en proceso y en la competencia de los auditores.
Es importante actualizar el programa de auditorías y revisar el plan de auditoría para asegurar que los objetivos de la auditoría, el alcance, los recursos, los riesgos de la auditoría y los riesgos al laboratorio por la auditoría están acordes a las situaciones actuales.
REALIZACIÓN DE LA AUDITORÍA REMOTA
Es recomendable realizar previo a la auditoría pruebas del uso de las plataformas de comunicación para la realización de la auditoría, para asegurar una conexión y uso apropiado. Adicionalmente preparar cámaras tanto asociadas a computadoras y móviles, así como accesos a cámaras de vigilancia dentro del laboratorio, cuando se requiera realizar atestiguamiento en la realización de análisis o muestreo. Para facilitar el atestiguamiento se recomienda utilizar plataformas que puedan ser utilizadas en teléfonos móviles, para facilitar la transmisión de la realización de ensayos, calibraciones o muestreo a los auditores. Al momento de las transmisiones hay que asegurar que se mantiene la protección de la información, para evitar el uso indebido de forma consciente o accidental.
En la reunión de apertura hay que prestar especial atención a cualquier modificación al plan de auditoría. Las situaciones a nivel mundial están cambiando rápidamente y los gobiernos pueden tomar disposiciones de un día a otro, por lo que es de suma importancia confirmar el plan de auditoría justo antes de iniciar la auditoría.
Según el organismo certificador NQA Ltd del reino unido, la auditoría remota debería durar lo mismo que una auditoría en sitio. Una buena práctica es compartiendo pantalla, para evitar compartir grandes cantidades de documentos entre auditados y auditores.
Es responsabilidad del equipo auditor el completar las actividades de auditoría programadas y realizar su mejor esfuerzo para lograrlo, en el caso de no ser posible cubrir todo el alcance de auditoría, pueden tomarse las siguientes medidas:
- Ampliar la duración de la auditoría, en acuerdo con el cliente de auditoría.
- Programar una visita posterior en sitio, si es posible, permitido.
Si no es posible alcanzar los objetivos de la auditoría, el líder del equipo auditor debe indicar claramente en el informe las actividades de auditorías realizadas y las que no lograron completar.
En las auditorías internas será decisión del cliente de auditoría considerar la representatividad de la información evaluada y la necesidad o no de realizar una nueva auditoría.
En las auditorías de acreditación la decisión sobre la validez la auditoría será decisión de la OA de acuerdo sus políticas.
BENEFICIOS Y DESVENTAJAS DE REALIZAR AUDITORIAS REMOTAS
Según Shauna Wilson experta en auditorias remotas de Amazon Consulting, las auditorías remotas son más eficientes que una auditoría presencial con beneficios como:
- Mayor enfoque que las realizadas cara a cara, ya que reduce las pláticas de otros temas.
- La elaboración del informe es más rápida ya que puede ser escrito durante la realización de la auditoría.
- Reducción de costos relacionados al traslado, boletos aéreos y viáticos del equipo auditor.
- Reducción de tiempo perdido durante el traslado del equipo auditor, especialmente cuando implica más de un día el traslado del equipo auditor.
- Homogenizar criterios de auditoría entre auditores de diferentes equipos de auditoría que regularmente no trabajan juntos por diferencias de ubicación, como el caso de tener auditores en diferentes sedes dentro de un país o una región.
Una desventaja importante de la auditorias remotas es que son altamente dependientes de la tecnología, de la calidad de la conexión a internet, las plataformas para realizar las reuniones, los dispositivos físicos para realizar la comunicación, entre otros. Muchas cosas pueden salir mal durante la auditoría remota, desde no tener energía eléctrica, problemas con la conexión a internet o dificultad con el uso de plataformas o dispositivos.
Los laboratorios pueden considerar previamente alternativas que puedan usar ante cualquier fallo, que pueden incluir tener un plan de datos de teléfono adicional al servicio de internet local, alternativas de plataformas de reuniones y como ultimas opciones el envió de documentos por correo electrónico y uso de llamada telefónica.
Es importante considerar que el éxito de la auditoría se logra en con una buena planificación y habilidad de equipo auditor para adaptarse eficazmente a las situaciones fortuitas que puedan ocurrir durante la auditoría, combinado con una amplia preparación previa a la auditoría por los auditados para facilitar las evidencias de auditoría y reducir contratiempos.
La pandemia del COVID-19 nos ha obligado a realizar actividades profesionales, académicas y sociales de forma remota utilizando la tecnología disponible. El proceso de auditorías remotas ya era conocido y utilizado de forma muy reducida, pero actualmente representa la principal opción de las organizaciones para cumplir sus objetivos del programa de auditorías. Como ocurre en las auditorías presenciales, la experiencia al realizar auditorías remotas es la mejor forma de aumentar la competencia de los auditores.
Actualmente estamos por descubrir si esta nueva tendencia logra predominar y ganar mayor aceptación en los laboratorios. Los invito a aprovechar las dificultades para fortalecer nuestros sistemas de gestión y realizar auditorías remotas, me gustaría conocer sus experiencias y casos de éxito.
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