We are a privately owned small business with an ISO Class 8 cleanroom and are
preparing for third-party certi;cation. When will we know to contract with a registrar?
Corporate Quality Assurance Manager
Cintas Corp., Mason, Ohio
One of the steps to prepare for a suc- cessful second party customer audit or a third-party registration audit is to conduct several first-party internal
audits. Establish a cross-functional internal audit
team and train them in the company’s audit
procedure, policies, and specific elements of the
standard relative to the third-party certification.
The internal audits conducted should align with
your industry’s best practices. All audits are
objective evidence and a snapshot of compliance
to written policies, procedures, and instructions.
This objective evidence should be discussed in
regularly scheduled management review meetings with representation from all areas of the
company. Senior management should be present
at all opening and closing audit meetings because
if senior leadership is not committed to this process, then no one else will be.
Most auditors prefer scheduled audits.
Yes, all companies strive to be “audit ready”
every day; however, auditors are more effective
and productive when the correct personnel
and resources are available to interview and
observe throughout a set schedule. Internal
audits should not be an annual event but timed
around work schedules and focused on critical
areas. Third-party audits must be scheduled
with a registrar months in advance to allow
for the selection and deployment of auditors
with knowledge of both the standard and the
company’s area of business and to reduce the
auditor’s travel expenses.
Start with an internal audit
Internal audits should cover the full spectrum
of the company’s processes and be designed
to close the loop between the industry’s
standards, customers’ specifications, and the
company’s people, processes, and product.
Checklists are often helpful in training inter-
nal auditors and ensuring consistency with
internal audits over time. Checklists also can
remind auditors to focus on items that require
more intense examination. Prepare checklists
to align with the elements of the standard
to which your company is registering. This
ensures the internal auditors comprehend the
standard’s elements and how the company is
interpreting compliance to these elements.
Auditors should evaluate the metrics used
by the company to evaluate quality and productivity of the process and the product. Key performance indicators (KPI), trends of customer
complaints and customer satisfaction, and
non-conformances observed in previous internal audits will provide the required objective
evidence to be documented.
Experienced auditors focus internal audits
on “what has changed” between the scheduled
internal audits. Personnel and equipment
changes can be opportunities for improvement.
However, implementation of the changes must
include effective personnel training and documented validation of equipment. Evaluation of
the associated documents will provide objective
evidence that the change(s) were effective or
identify areas requiring improvement.
Corrective action and review
Another area to evaluate is corrective action
reports issued because of internal and/or external customer complaints. Trends of a company’s
corrective action reports can focus on repetitive
events and the top three issues requiring correction. Auditors can provide insight into whether
the root cause investigation has discovered the
true failure to prevent another occurrence of
the non-conformance. Re-training is never the
correct preventive action.
Once the review of documen-
tation, observation of the process-
es, and interviews with company
personnel is completed, an internal
audit report is prepared within a
scheduled timeframe. This audit
report should recognize areas that are
meeting customer specifications and
areas that are compliant with company’s
policies and procedures, and industry standards.
Internal audits should also focus on opportuni-
ties for improvement and can be reviewed in the
next scheduled internal audit when documented.
As previously stated, the results of all internal
audits should be reviewed during regularly
scheduled management meetings. During the
review, personnel can discuss ongoing metric
evaluation and use past internal audit information for future internal audits. It is important
to keep all personnel and departments focused
on the same objective—creation of a climate of
performance excellence and successful second
and third-party audits.
Internal audits are the cornerstone of an
effective and mature quality management
system. Organizations with quality management failures, customer dissatisfaction, and
unsuccessful second- and third-party audits
can trace the failures back to an ineffective
internal auditing program. Once you have a
comprehensive audit program in place, you
will be prepared for the third-party certification program.
Jan Eudy is a technical resource for ESD, cleanroom, food, and healthcare garments and products.
At Cintas, she directs the quality system and ISO
registration for cleanrooms and supports validation
and sterile services. She is President Emeritus and
Fellow, Institute of Environmental
Sciences and Technology.