The Challenges and Benefit of

Internal Auditing
Ni Ken Ritchie
Jakarta Blood Center – Indonesian Red Cross

NRL - Hanoi 2019 - NR

 OUTLINE
• Quality Management System
• What is internal audit
• What to prepare
• How to conduct
• What is the challenge
• What is the benefit

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 COMPLEXITY OF A LAB SYSTEM

•Data &

How do we achieve
Laboratory
Management
•Safety
excellent •Customer
Service

performance in the
laboratory?

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QMS
Minimizing the lab errors

many steps test results

accuracy of accurate will be used
Complexity of activity
the testing in clinical
of the lab
and and public
process many reporting inaccurate health
people settings

• unnecessary treatment
• treatment complications failure to provide the
proper treatment
• delay in correct diagnosis
• additional and unnecessary diagnostic testing.

increased cost in time and personnel effort

Often poor patient outcomes.
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Laboratory quality can be defined as

Accuracy of the laboratory results

Reliability of all aspects of the laboratory

operations

Timeliness of reporting to be useful in a

clinical setting or public health setting
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12 Quality System Essentials

set of
coordinated
activities that
function as
building blocks
for
quality
management

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 12 Quality System Essentials
• a strong supporting organizational structure—

Organization • management commitment is crucial—

• and there must be a mechanism for implementation
and monitoring

Personnel • Sufficient (enough), competent, motivated staff.

• Choosing the right equipment, installing it

Equipment correctly, ensuring that new equipment works
properly, and having a system for maintenance

Purchasing • to ensure supplies and reagents are available when needed,

• are of good quality,

and inventory • To ensure that they are used and stored in a manner that
preserves integrity and reliability.
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 12 Quality System Essentials
Process • Quality control for testing, appropriate
management of the sample, including collection
Control and handling, and method verification and
validation.

Information • Confidentiality, requisitions, logs and records,

reports

management • computerized laboratory and information

systems (LIS)

Documents • Documents à to inform how to do things (creation,

control, reviewed and update)

and records • Records à maintained so as to be accurate and

accessible (review, retention)

Occurrence • an error or an event that should not have happened.

• A system is needed to detect à handle them properly
management à find the rootcause àtake action à not happen again
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 12 Quality System Essentials
• A tool for examining laboratory performance and comparing it
to standards, benchmarks or the performance of other
Assessment laboratories.
• internal : quality indicators, audit program
• external : proficiency test, accrditation

Process • The primary goal in a quality management system

Improvement • This must be done in a systematic manner.

Customer • customer group identification

• customer needs
services • customer feedback

•Security

Facilities •Containment
•Safety
•Ergonomics

NRL - Hanoi 2019 - NR

INTERNAL AUDIT

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DEFINITION OF INTERNAL AUDIT
The ISO definition for audit is a “systematic,
independent and documented process for obtaining
evidence and evaluating it objectively to determine
the extent to which required criteria are fulfilled.”

An assessment can be defined as the systematic

examination of some part (or sometimes all) of the
quality management system to demonstrate to all
concerned that the laboratory is meeting regulatory,
accreditation and customer requirements.

Audits should include the evaluation of steps in the

whole laboratory path of workflow. They should be
able to detect problems throughout the entire
process.
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 Laboratory Standards
• The laboratory assessment based on accepted standards, whether
international, national, local, or standards from accrediting
organizations :
– ISO 15189:2007. Medical laboratories—particular requirements for
quality and competence. Geneva: International Organization for
Standardization, 2007.
– ISO/IEC 17025:2005. General requirements for the competence of
testing and calibration laboratories. Geneva: International
Organization for Standardization, 2005.
– Clinical and Laboratory Standards Institute, or CLSI, formerly known as
the National Committee for Clinical Laboratory Standards (NCCLS) .

– National laboratory quality standards that apply specifically to

laboratories within the country.
– The World Health Organization has established standards for some
specific programmes and areas.

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 The objective of Internal Audit

To monitor implementation and compliance with the quality

management system.

To assess compliance with internal requirements and applicable

national and/or international regulations. (not a substitute for official
inspections performed by the competent national authorities)

To know which policies and procedures that the laboratory has set
required revision or are not being followed by identifying any gaps or
nonconformities in performance.

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 The benefit of Internal Audit
Self check before external audit

Increase staff awareness of quality system requirements

Identify the gaps or nonconformities that need to be corrected à the

opportunities for improvement;
Understand where preventive or corrective action is needed;

Identify areas where education or training needs to occur;

Trust from stakeholders

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WHAT TO PREPARE

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 Internal Audit
• Be performed according to an established procedure
• Arranged an audit plan à schedule, short and
frequent, section-specific
• Auditee : should cover all parts of the operations,
including data processing systems.
• Set an audit checklist, prepare forms for
recording corrective actions and reports
• Appoint internal auditors à trained,
independent and competent persons

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 Internal Auditors
Independency Objectivity

• Internal audit should not • The same conclusions and

assess his division opinion should be reached
• No pressure from by any professional
directors and managers internal auditor reading
the evidence on file.
• Your objectivity isn’t
compromised or could be
challenged due to
personal or business
relationships.

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HOW TO CONDUCT

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 AUDIT PLAN

¡ A pre-arranged programme should be in place for

auditing and self-inspection of :
§ personnel matters, à staff competence and training
§ premises,
§ equipment,
§ Documentation à processes and operating procedures
§ Recording and reporting practices
§ collection, processing, testing, storage, distribution and
issuing of components,
§ the arrangements for dealing with complaints and recalls.
§ Quality control and verification of results

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 Procedure of Internal Audit
Step Activities
1. Opening meeting by lead auditor à explain coverage, schedule,
standards and how the audit will be performed
2. Auditors audit the laboratory using audit checklist form
3. Auditor explain and discuss the risk of each findings to the
auditee when it is finished.
4. Auditors write the findings on the report form .
5. Closing meeting à lead auditor reports to top management the
findings and auditee.
6. Auditee should make Corrective and Preventive Action Plan, also
change plan if needed

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WHAT HAPPENS DURING INTERNAL AUDIT

When an internal auditor comes, they will

• analyze documents regarding the laboratory’s risk,
objectives and performance,
• observe how the procedure is being implemented
• take notes
• interview personels à safety standards, compliance rules.
• Collect evidences / records

Asses compliance to standard & requirements

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 Results of INTERNAL AUDIT

Should be documented

Reported to the management.

Appropriate corrective and preventive actions

• should be taken in a timely and effective manner
• should be assessed for effectiveness after
implementation.

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CHALLENGES

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 CHALLENGES
• There is difficulty in finding the ‘right talent’. à integrity, courage,
attention to detail, conflict management skills, business process
knowledge, ability to communicate well and many others à trained
• Delivering Additional Value to the lab
à It is critical so you can ensure your scope, review and
recommendations are fit for purpose and have benefit for them
• Gaining trust from auditee.
à People will quickly dismiss ideas if they think you lack an
understanding of how they operate and do not cooperate while
auditing
• How to have buy-in and a willingness from senior management to
implement change.

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 CLOSING REMARKS
• Internal Audit is really important for a
laboratory to know their compliances to the
standard and guidelines to achieve the
laboratory quality.

• Plan it and do it with a competent internal

auditor to have the optimal results to achieve
continuous improvement in the laboratory

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QUALITY IS A JOURNEY NOT A DESTINATION

THANK YOU

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