Fall Newsletter 2020 - web version - Flipbook - Page 13
IAS Newsletter | Fall 2020
Utilizing Remote Assessments as a tool in the
Accreditation Process
By Dr. George
Anastasopoulos
VP, Global Development & Compliance,
International
Accreditation Service, Inc.
A. Introduction
Organizations
around the world have pivoted to remote
work amid the COVID-19 pandemic. And
to a remarkable extent, many of them have
been able to successfully carry out much
of their business operations. Among those
organizations are accreditation bodies that
have chosen to replace a significant part
of their onsite assessments by remote
assessments. IAS had already implemented such practices in extraordinary circumstances for more than 5 years, accumulating significant experience. Still it was only
the last few months, during the COVID-19
pandemic, that IAS systematically utilized
remote management system assessments
as a standard practice for a considerable
number of carefully selected assessments,
based on the complexity of the scope of
accreditation.
A remote management system assessment is when electronic means are used
to collect assessment evidence by utilizing
electronic communication tools. A remote
assessment means assessing from a
remote location. According to IAF ID
12:2015, remote assessment is defined as
“…the facilitation of assessment of a Conformity Assessment Body from a location
other than that being physically present”.
The methods used to converse from a
remote location may include one or a
combination of technologies such as telephone communication, videoconferencing,
e-mailing, online chat rooms etc. The new
ISO 19011:2018 “Guidelines for auditing management systems” has already
incorporated language to address remote
management system audits.
The obvious benefit of remote assessments is more efficient use of resources.
Remote assessment techniques can save
assessor travel time and expenses. It will
also facilitate situations where a site is
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not easily accessible, or when there is
an urgent need for assessment, and in
extraordinary situations such as medical
emergencies-quarantines, pandemics, etc.
On the other hand, onsite assessments
need more time for preparation and implementation and in many cases, they don’t
provide the same flexibility as the remote
assessments.
B. Collecting data, information
It is IAS primary concern that when
performing remote management system
assessments, it is ensured that whatever means are used, the credibility of the
assessment results is maintained. The
outcomes/deliverables of the remote
assessment are expected to be the same
as the ones collected by an assessment
in which on-site or direct means are used
to identify evidence. The same agenda assessment report and checklist documents
are also completed by IAS assessors and
are submitted to IAS for review.
During the remote assessment appropriate
data is collected to verify conformity to
the assessment criteria. The data must be
enough to verify conformity, free of bias
and representative of the current status of
the area/activity being assessed.
During remote assessments and in order
to achieve assessment efficiency by
recording and analyzing information provided electronically the client is required to
provide more information in advance of the
assessment. In that case the client is required to complete checklists and submit
specific records, before the assessment,
reporting on the controls in place or recent
changes in their system or process.
Three elements of an assessment are affected when the assessment is performed
remotely:
1. Interviewing
This can be conducted remotely using
teleconference technology. In preparation
for the remote interview, the lead assessor
must communicate with the interviewees
in order to agree on the arrangements, including software to be utilized, dates, time
etc. Time difference is always considered.
When the assessor is planning to perform
the interview from home then additional arrangements are expected to avoid possible
distractions.
The assessor needs to check in advance to
ensure that both the client and the assessor have access to compatible operational
instrumentation, software/apps, microphones, speakers, video camera etc.
Assessors also need to submit a specially
developed questionnaire for the client to
answer prior to the interview. Based on the
answers to the pre-interview questions,
the assessor prepares the actual interview questions and they are determining
the tools needed to collect assessment
evidence.
Remote assessing issues to be taken under consideration by the assessment team
members include the following:
Preparation needs to ensure that interviews are punctual.
The room to be used for the interview is
suitable.
Become familiar with the communication equipment/software/app.
Beware of weak or unstable internet
connection. (Assessor and client should
be prepared to use telephone if internet
connection is not stable).
Considerations regarding usage of
cameras and video equipment that
could be banned due to security issues.
(Assessor must be sure beforehand that
the client will agree to use video image
capturing technologies).
2. Reviewing and verifying documents and
records
This process can be performed off site
if the assessor has access to any kind of
electronic document control system. Records can be forwarded to the assessor, as
requested, using different methods such
as mail, skype, WebEx etc. The electronic
document control system/app to be used
must be agreed with the client before conducting the remote assessment.
The assessor will need to be prepared
and able to select records to be verified
during the interview, such as test reports,
IAS Fall 2020 Newsletter
inspection reports or calibration reports,
certificates, personnel files etc. In this
way, off-site verification of documents and
records could be as effective as on-site assessment and could save assessing time.
The potential issues to be considered and
resolved before the remote assessment
are the need for scanning equipment for
paper copies, if any, gaining remote access
to the documents used by the client, and
the time it takes to be trained on accessing and navigating the document control
software/app.
3. Witnessing
Remote assessment practices for actual
witnessing (of a process such as a test, or
inspection, or audit) can be used to collect
data online. Collecting data remotely is
more demanding when performed remotely in real time. It is possible to use a digital
camera to observe the process and review
related evidence. Surveillance cameras
could be used, but they should be avoided
because their quality or functionality could
be inadequate.
Each situation should be evaluated based
on data access and importance of the process or assessment risk. For some remote
assessments, data collection may need to
be skipped or verified during a later on-site
assessment.
For remote assessments, observing
specific processes may not be important
for certain areas. For example, setting up
cameras to watch the human resources
or purchasing department at work is not
going to yield better information than
asking the auditee directly for the required
data. But watching the lab’s specimen
conditioning area or observing the testing
area surroundings could be important
because there may be physical signs
effecting testing implementation. Similarly, when process implementation, ongoing
process controls, or process outputs need
to be observed, appropriate real-time video
surveillance may be needed.
C. Remote assessment considerations
The following questions should be
answered when preparing a remote
assessment:
Assessment scope and objectives or
purpose
Can the remote assessment be performed during an initial accreditation,
a surveillance, a reassessment and/or
scope expansion?
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IAS assessors are expected to consult
the respective program manager for
instructions per case.
Nature of the processes to be assessed
Does the process to be assessed involve
oral communication or documentation,
retrieval of records and document control?
IAS assessors are trained on how to
understand the client processes before
conducting the remote assessment
(using checklists, client’s Quality Manual
and/or other MS documentation).
Type of instrumentation, equipment and
materials involved in the process to be
assessed
Which parts of the (testing/calibration/
inspection etc.) process should be
demonstrated?
IAS assessors are expected to define
which parts of the operation, that need
to be observed, are critical for verification of conformity.
Number of client facility areas that the
assessor wishes to observe
Which areas should be covered?
The IAS lead assessor is expected to
define and agree with the client, in advance, the areas to observe.
Scheduling
What is the preferable time to schedule
the remote assessment?
The IAS lead assessor is expected to
acknowledge and manage time zone
issues and try to coordinate reasonable and mutually agreeable convening
times.
Time management
How long will the remote assessment
take?
IAS has performed a series of pilot
remote assessments in the past. It was
found that additional time is required
to perform a remote assessment at
the same level of quality as a regular
assessment. Therefore, it is recommended to schedule for additional time
and be prepared well, before the on-site
assessment, addressing the issues
noted above.
Communication tools
Will the communication tools be adequate?
The IAS lead assessor considers the
availability of appropriate electronic
communication equipment, as well as
the capability of the IAS team assessors
and client to operate electronic communication equipment and address any
applicable security requirements.
A trial meeting with the client using the
agreed upon media platforms could be
conducted to ensure that the scheduled
assessment will perform as planned.
Conclusion
A remote assessment, for accreditation
purposes, can be considered in many cases (depending on the applicable accreditation standard and the scope of accreditation) as an acceptable alternate to on-site
assessments during extraordinary circumstances such as a pandemic. Accreditation
bodies around the world have implemented such assessments during the COVID-19
pandemic, carrying out, successfully,
much of their accreditation operations.
During that period IAS had also replaced a
significant part of its onsite assessments
of selected clients’ management systems
with remote assessments. The experience
of this process indicates that its success is
heavily dependent on the availability of the
appropriate instrumentation and software,
the careful preparation and the adequate
training of involved staff. It is the opinion
of IAS personnel involved in this process,
that the on-site assessments are, still, a
superior auditing tool, for accreditation
purposes.
Bibliography:
IAS SOP 28, Conducting Remote Assessments, October 2019
IAS Remote Assessment Guide, v1, April
2020
IAF Informative Document Principles
on Remote Assessment Issue 1 (IAF ID
12:2015)
ISO 19011:2018 “Guidelines for auditing
management systems”
IPC Guidance Document BD-04-006, Performing A Management System Audit –
Auditing Techniques, 2015
Remote Control, is e-auditing the next
logical step? by J.P. Russell
Remote Audit: Out of Sight but Not Out
of Mind, by David Ade
Dr George Anastasopoulos is
Vice President for Global Development &
Compliance at International Accreditation
Service, Inc. (IAS). He can be contacted at
ganastasopoulos@iasonline.org
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