QP 0920 Coleman

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F E AT U R E

AUDITING

16 QP September 2020 ❘ qualityprogress.com


The COVID-19
crisis has brought
remote auditing to
the forefront.

There are definite


pros and cons to
remoting auditing
that auditors
must be aware of
before deciding
which route to
take.

A remote audit
requires planning,
time, resources
and implementa-
tion of auditing
best practices,
just as if conduct-
ing an on-site
audit.

Taking adequate
time and follow-
ing best practices
fatido/matejmo via Getty Images

may be even
more important
when conduct-
ing a remote
audit. The author
offers eight best
practices to
incorporate into
remote activities.

Advice on getting the most out of remote


auditing to minimize risk and manage
suppliers | by Lance B. Coleman Sr.

qualityprogress.com ❘ September 2020 QP 17


F E AT U R E
AUDITING

The ongoing COVID-19 crisis has emphasized the


importance of maintaining a strong supply chain.
An important aspect of supply chain management
is the supplier audit process. With several travel
restrictions and social distancing requirements
in place, many audits are being converted from
on-site visits to remote interactions.
However, without the ability to witness opera-
tions, tour facilities and interview operators at their
respective workstations, how can a truly thorough
audit be conducted? And how can a truly robust
remote audit be conducted?

What a remote audit is and isn’t


ISO 19011:2018—Guidelines for auditing manage-
ment systems defines an audit as a “systematic,
independent and documented process for obtain-
ing objective evidence and evaluating it objectively
to determine the extent to which the audit criteria
are fulfilled.”1
There are many different terms used to describe
various types of remote auditing: e-auditing,
virtual auditing, desk auditing and document audit-
ing are some of the most common. Sometimes,
the terms are used interchangeably and sometimes
with differing definitions. Often, document or desk
audits are considered the document review portion
of a larger audit, completed prior to the opening
meeting, whether onsite or virtual.
For the purposes of this article, remote audit-
ing applies to all of these terms and is defined as To successfully prepare for audits, the
“when audit activities are conducted by the audit lead auditor must identify any risks to a
team, either simultaneously or while engaged with successful audit, and plan and implement
the auditee, when not physically on the audit site.” mitigations for them.
These activities may include reviewing documented
information, conducting interviews, observing via
video feeds, analyzing data and trends, and rein- There is a place for supplier self-assessments
specting product via a video of a reinspection. but not in lieu of an independent audit.
Before considering what a robust remote audit + Filling out any other form. No other form com-
entails, think about what a remote audit isn’t: pleted by a supplier—whether it is some titled
+ Completing a self-assessment checklist. assessment, audit or review, or pertains to the
That includes one aligned with the clauses QMS or aspects of manufacturing operations—
of an applicable International Organization should be considered an audit.
for Standardization (ISO) quality manage- + Reviewing the quality manual and ISO certif-
ment system (QMS) standard. An audit is a icate. Whereas this is a good thing to do and
process, and a process means there is work should be part of an audit, in and of itself, this
being done by the process owner. In other level of assessment does not constitute an audit.
words, an auditor can’t pass off his or her + Skipping an on-site visit because of time or
work on the supplier to assess its own QMS. money factors. Conducting a remote audit should

18 QP September 2020 ❘ qualityprogress.com


be a conscious, planned decision balancing risks as seriously as on-site audits. This is not always
and resources. It should not be an ad hoc decision the case, but often enough.
based on the easiest path during a time of duress. “Something to be wary of is that there can
That is why it is critical to have an established sometimes be a tendency to make desk audits a
decision-making framework that determines when ‘checkbox’ exercise if it is decided that there will
a remote audit might be appropriate, as part of not be an accompanying on-site audit,” according
the supplier management process. to Managing Organizational Risk Using the Supplier
Does this scenario sound familiar? Two auditors Audit Program. “This is a big mistake! A properly
are assigned to perform a two-day on-site audit of conducted desk audit can take hours to complete—
a supplier. Business necessities require the audit to minimally between four and eight hours.”2
be converted from an on-site visit to a desk audit. A remote audit requires planning, time,
Suddenly, only one auditor is needed, and the audit resources and implementation of auditing best
is expected to be completed in half of a day. practices, just as if conducting an on-site audit.
iStock.com/MediaProduction

Granted, some time can be saved because In fact, taking adequate time and following best
remote audits don’t require presence on the shop practices are even more important when con-
floor, but the overall breadth of the audit and effort ducting a remote audit because you lack the
required to conduct remains the same. Where benefit (in most cases, at least) of being able
does this disconnect come from? In too many to witness operations occurring on the floor and
cases, quite frankly, remote audits aren’t taken comparing them with documented expectations.

qualityprogress.com ❘ September 2020 QP 19


F E AT U R E
AUDITING

Pros and cons of remote auditing + Difficulty seeing operations in action.


There are many reasons, even during normal Review process maps and plant layouts,
times, to conduct remote audits. and ask for descriptions of how a process
+ They are less expensive, require fewer resources works. Understand inputs and outputs to
and can be less intrusive on the auditee. a process being reviewed. Stream or record
+ They allow for multitasking. Auditors can work short videos in high-risk select instances.
on the audit for part of the day and other tasks + Missed visual cues. Turn on the video during
during the rest. Auditors also can work on more a virtual meeting, for instance, and ask the
than one audit at a time. auditee to do the same when asking specific
+ There is flexibility in being able to conduct an or pointed questions. This is not as import-
audit over a more extended period of time, ant if someone is just providing a general
when necessary. description of how a process works.
When done properly and under the correct + Poor time management. Read two to three
circumstances, remote auditing can meet ISO and times as many documents in advance as you
regulatory requirements for supplier oversight. typically would for an on-site audit so you can
It is the cons or risks associated with remote be as efficient as possible in your questioning.
auditing that sometimes give pause. A deeper Begin the records review before the audit if the
dive into remote auditing process risks is needed, auditee will send them. When possible, complete
therefore, because these must be mitigated to the review of documents and records pertaining
ensure a successful audit. to certain low-risk aspects of the QMS before
The following list is meant to be comprehensive the audit so minimal interview time is taken up
but certainly not exhaustive. The key takeaway? during the audit execution around those topics.
To successfully prepare for audits, the lead auditor + Reluctance to email documents and records.
must identify any risks to a successful audit (such If auditees resist, suggest screen sharing to allow
as these concerns), and plan and implement miti- the review of documents and records during the
gations for them. These could include: audit. Request remote guest access to review

FIGURE 1

Virtual audit process

Process inputs Virtual audit Process outputs

+ Auditor + Audit report


+ Auditee + Audit records
+ Planning + Risks
+ Meetings
+ Digital integrity review
iStock.com/Ani_Ka

+ Interviews
+ Observations
+ Technology
+ External standards
+ Historical record review

20 QP September 2020 ❘ qualityprogress.com


Yuichiro Chino via Getty Images

Auditing best practice


Conducting a robust remote audit can be time A remote audit is just that: an audit. General best
consuming and difficult. If you don’t find it that way, auditing practices should apply. Don’t fall into
you’re likely not doing it right. the trap of not using best practices during your
audit because it is “just” a desk (remote, virtual
or e-​audit—choose your word here) audit.
files in advance without having to down- Then, of course, there are best practices more
load them. germane to the virtual world. A map of the virtual
+ Uncovering more system issues than perfor- audit process is shown in Figure 1. Beware of the
mance issues. Ensure that a broad range of risks of conducting a poor remote audit that can
records is reviewed, including trend data. lead to the risks of poor supplier oversight, as well
+ Greater chance for distractions. Avoid as risks of management making a poor decision
extended periods of time in which the audi- based on faulty audit data.
tee is just sitting and waiting while the auditor In general, here are some auditing best prac-
reviews documents or records. Leave the vir- tices for you to incorporate into your remote
tual meeting space when that must be done audit activities:
and reconnect when finished. Avoid having General planning. Review the last audit report
multiple people waiting while one auditee in addition to performing a 12-month review of
must provide a lengthy question response. nonconforming material reports, corrective and
+ Discomfort with a virtual environment (either preventive actions, corrective action requests,
auditee or auditor). Do a practice run before the complaints and other data to help determine
first meeting. Know simple troubleshooting tips audit strategy, focus and development of a check-
(for instance, audio troubles including squeals list. Request a document matrix to help select the
and feedback). Have IT on standby to assist. best sample of documented information to review.
+ Differing time zones. Be mindful when sched- Remote planning. Allow gaps in the schedule
uling meetings. Know what time it is in the to break and review documents and records.
auditee’s location. The auditor is the one who Be sure all audit team members are comfortable
should be accommodating when early morning and technologically compatible with the platform
or late-night hours are necessary. being used. Determine which objective evidence

qualityprogress.com ❘ September 2020 QP 21


F E AT U R E
AUDITING

TA B L E 1 a remote audit are that a follow-up on-site audit

Preparing for a remote audit


must be conducted. That should be made clear
during the opening meeting if that’s the case.
Be efficient. Have a list of documents and
records to be pulled when you break to review
Remote vs. on-site preparation information. Also, when there are two auditors,
Audit process aspect comparison
have one offline preparing while the second
engages with the auditee. Then, the second auditor
Planning Additional considerations for remote
can log into the meeting to ask his or her questions
while the first auditor logs off to review other docu-
Meetings Additional considerations for remote mented information.
Don’t be afraid to request photos or short videos
Data integrity review Fairly equivalent of complex or high-risk areas. The auditee may
decline, and you don’t want to make this request
Interviews Fairly equivalent lightly, but it doesn’t hurt to ask when reviewing
additional visual information is warranted. This
request might lead to additional dialogue around
Observations Additional considerations for remote
other possible options for getting this information
(for instance, determining timing, signing a nondis-
Technology Multiple unique aspects for remote closure agreement and scheduling an on-site visit).
General reporting. The audit report should
External standards Fairly equivalent include a definition of finding classifications and
expected response timelines, as well as detail
Historical record review Fairly equivalent and summary information relating to the audit pur-
pose, scope, team and results. When documenting
a finding, the statement should include what the
Reporting Fairly equivalent
requirement is, what was observed, a conclusion
and justification (one to two sentences) for that
Managing audit risks Additional considerations for remote conclusion. Make sure the audit report form has
checkboxes to indicate whether the audit con-
ducted was on site or remote.
would be OK to review asynchronously, and which Remote reporting. Screen share so the auditee
evidence would be best to review with the auditee. can see the findings as you review them. Excerpt
Remote audits provide an opportunity to send just the audit conclusion and findings from the
certain questions in advance with a request for report to screen share so you don’t need to scroll
objective evidence so the auditee can be ready through pages of information to get to what the
to review when the auditor engages them. auditee most cares about: audit results.
General execution. Conduct opening, closing General closure. Close as appropriate and within
and end-of-day meetings. Include time in the the expected timelines per your existing proce-
schedule for consolidation or discussion (if more dures. Though photos, if sent, may be included in
than one auditor) of the day’s findings prior to the audit report, be sure to delete any files sent to
presentation. Be considerate of the auditee’s time. you as objective evidence because this is company
Conduct interviews with multiple people and not confidential information belonging to the supplier.
just the management representative. Maintain Etiquette. Put special emphasis on assurances
a conversational and convivial style throughout that information shared will be kept confidential.
the proceedings. Be sure to ask permission before screen capturing
Remote execution. Be sure to allow 30 minutes any information presented. Work from a location not
prior to the scheduled start time to troubleshoot prone to background noise or poor lighting. Remain
any unexpected issues. Sometimes, the results of attentive and focused when someone is speaking or

22 QP September 2020 ❘ qualityprogress.com


Updated Quality
Auditor Handbook
Lance B. Coleman Sr.’s latest book, the fifth edition of The ASQ
Certified Quality Auditor Handbook, was published late last
month by Quality Press. The handbook is an in-depth overview
of the principles, implementation and uses of quality auditing
and aligns with the most recent certified quality auditor body
of knowledge. For more details, visit asq.org/quality-press.

presenting. Do everything you can to ensure there acceptable quality limits for new or existing suppli-
are no delays or issues caused by your lack of under- ers until an on-site audit is possible to supplement
standing of how the auditing platform works. Lastly, the remote assessment.
“please” and “thank you” always work. Although the focus of this article is conducting
successful remote supplier audits, many of the
Time and preparation required principles discussed also would apply to conducting
The on-site and remote comparison matrix (Table internal audits between sites.
1) shows for various aspects of the audit process,
REFERENCES
remote audits are comparable to on-site or more 1. International Organization for Standardization,
complex ones. How can you afford not to put as ISO 19011:2018—Guidelines for auditing management
much time into preparing? Use the matrix as a systems, 2018.
2. Lance B. Coleman Sr., Managing Organizational Risk
guide to determine where to focus your efforts Using the Supplier Audit Program, Quality Press, 2018.
in preparing for a remote audit.
Conducting a robust remote audit can be time
consuming and difficult. If you don’t find it that way,
you’re likely not doing it right. Being comfortable
with the electronic platform used to conduct the Lance B. Coleman Sr. is director of
audit and having knowledge of basic troubleshoot- quality for IDEX Health and Science
ing tips also is important. By adhering to auditing LLC in Oak Harbor, WA. He earned
an associate degree in electrical
best practices while identifying and mitigating engineering technology from Southern
the unique risks found in remote auditing, robust Polytechnical University in Marietta,
remote audit results can be achieved. GA. A senior member of ASQ, Coleman
holds the following ASQ certifications:
What should you do when risk assessment quality auditor, biomedical auditor, quality engineer and Six
dictates that an on-site audit should be done, Sigma Green Belt, along with the Exemplar Global quality
but business realities state it can’t happen and management systems principle auditor certification. He is the
author of Advanced Quality Auditing: An Auditor’s Review of
there’s no way to delay the audit? In such cases, Risk Management, Lean Improvement and Data Analysis (Quality
you would do the most robust remote audit Press, 2015), Managing Organizational Risk Using the Supplier
possible and couple the audit with other controls. Audit Program (Quality Press, 2018), and The Customer-Driven
Organization: Employing the Kano Model (Productivity Press,
Two examples of such a scenario would be condi- 2014). He also is editor of the Quality Auditing Handbook,
tional acceptance for new suppliers or increased fifth edition (Quality Press, 2020).

qualityprogress.com ❘ September 2020 QP 23

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