Internal Audits: Facts, Findings and Reports

By Laurie Munk

On Thursday (new assessors) and Friday (all assessors), AABB assessors received valuable training to ensure that they do their part in maintaining the strength of the association’s accreditation program. Representative of the sessions was a presentation by Dennis Arter, FASQ, CQA(ASQ), of Columbia Audit Resources.

His talk on internal audits was lively and informative, and gave his audience tools to increase their competence — not only as assessors of member institutions but as employees in their own facilities.

“Just the facts, ma’am”
The initial stages of an internal audit involve the facts — as determined by a comparison of the requirements (of the facility itself as well as external entities) and the evidence (see figure below). Arter reviewed the different types of evidence in prelude to a discussion of the following issues:

• What is the difference between fact and opinion?
• How can facts be obtained effectively?
• Why is it desirable to challenge and refine facts?

He continued with examples of facts discovered through an internal audit, listing the good, the bad and still more bad. He offered the following among others:

• Blood bag labels are ISBT 128 compliant.
• The 48-quart cooler used for transporting whole blood from bloodmobiles to the central facility was not validated before use.
• QC records show that only 80 percent instead of 95 percent of leukocyte-reduced units sampled met requirements.
• No installation qualification was performed on new incubator #1234, now in use.
•  Daily consistency temperature checks were not performed on May 24 of this year.
• Of the 18 autologous donor-patient records examined, one lacked a physician’s order.

Using Facts to Identify Problems
Arter further explained the process for using the facts as tools to define problems or identify cause-and-effect relationships. The first step in the process is to take all the facts collected and list them under two headings: good and bad. From this point forward in the internal audit, the focus is on those facts in the “bad” category.

Next, the facts that are similar or share something in common (eg, equipment maintenance, documentation, even “miscellaneous”) are grouped to define problems. For instance, the facts that 1) a cooler was not validated before use, 2) temperature checks on blood storage equipment were not performed on a particular day, and 3) no installation qualification was performed on a new incubator could all be considered equipment maintenance problems.

In the final stages of an internal audit, findings are analyzed to develop a plan for improvement. Remedial action is used for immediate fixes of individual items. They are short-term fixes, quick and easy to accomplish. Remedial action is for the symptoms.

In contrast, corrective action takes longer. Corrective action is for the disease. Determining the underlying causes requires more than one person and several days. Fixing the underlying causes requires at least a month, and ensuring that the corrective action was effective requires a year’s worth of data.

Audit Credentials
In closing, Arter emphasized the importance of credentials for auditors. He was pleased that many assessors in the audience responded when he asked for a show of hands by those holding a CQA certification from the American Society for Quality. He noted the certification’s excellent reputation in varied industries, explained how the examination questions and body of knowledge are updated and encouraged assessors to consider preparing for the examination.

Credentials for Auditors

Auditor Hierarchy

• Audit Boss qualifies the Team Leader.
• Team Leader qualifies the Audit Helpers.
• All need communication skills, technical knowledge and audit knowledge.
• All auditors should have papers to show that they are qualified.

American Society for Quality Certification

• CQA(ASQ) has high credibility worldwide.
• Certification is applicable across all industries.
• Exam questions are individually analyzed and constantly refreshed.

CQA Examination

• Apply at least two months in advance (www.asq.org/certification).
• Prepare via a year’s experience, local refresher courses and standard texts.
• Four-hour open-book exam is given locally.
• Renewal is every three years (18 CEU points). 
  

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