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Accreditation and Certification: Definition

Certification: Procedures by which a third party gives written assurance that a product, process or service conforms to specific requirements.

Accreditation: Procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks.

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Accreditation and Certification: Definition

Certification: Procedures by which a third party gives written assurance that a product, process or service conforms to specific requirements.

Accreditation: Procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks.

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The Accreditation body which oversees the assessment and grants accreditation (and may also set the standards)

The Standards with which a laboratory has to comply in order to gain accreditation

The Assessors or Inspectors who seek to establish compliance with the standards by conducting the assessment

The User Laboratory which is required to, or voluntarily seeks to, comply with the standards by being assessed.

Accreditation: Elements

Non-conformity Management

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Objectives

On completion of this session the reader will:

1. Understand the term “Non-conformity”.2. Know the essential monitoring tools.3. Know preventive actions, remedial

actions, and corrective action and why they are associated and different.

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To show presence of control:

Say what you Do, Do what you Say, Write it!

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DefinitionsISO 9001-2000

Audit Systematic, independent and documented process for obtaining

audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.

Vertical Audit and Horizontal Audit Non-conformity

Non-fulfillment of a requirement Corrective action

Action taken to eliminate the cause of a detected non-conformity or other undesirable situation

Preventive action Action taken to eliminate the cause of a potential nonconformity

or undesirable potential situation Continual improvement

Re-occurring activity to increase the ability to fulfill requirements

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The Quality System

Process Control

(Quality Control & Specimen

Management)

Purchasing & Inventory

AssessmentNon-

conformity Management

Information Management

Process Improvement

Customer Service

Facilities & Safety

Organization Personnel Equipment

Documents & Records

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What is a Non-conformity

- Any event that has a negative impact on an organization, which includes personnel, product, equipment, or the environment.

- Can arise in two distinctive ways “Reactive audits” and “Proactive audits”

Major non-conformityMinor non-conformity

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What are common laboratory non-conformities?

Patient identification error Lost specimen Late specimen Contaminated samples Performing a wrong test Performing a test

inconsistent with the written procedure

Proficiency Testing error Out of Range Controls A false negative result Late reports Errant reports Received complaints Laboratory safety accident A “near miss”

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Why Do Errors Occur?

Some causes include: Individual responsibilities unclear No written procedures Written procedures not followed Training is not done or not completed Checks not done for transcription errors Test kits not stored properly QC, EQA not performed Equipment not properly maintained

Errors can occur throughout the testing process

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Pre-testing Errors

Examples include: Wrong specimen collected Specimen mislabeled or unlabeled Specimen stored inappropriately before

testing Specimen transported inappropriately Reagents or test kits stored

inappropriately

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Testing ErrorsExamples include: Established algorithm not followed Incorrect timing of test Results reported when control results out of

range Improper measurements of specimen or

reagents Reagents stored inappropriately or used after

expiration date Dilution and pipetting errors

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Post-testing Errors

Examples include: Transcription error in reporting Report illegible Report sent to the wrong location Information system not maintained

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Consequences of Laboratory Error

Inadequate patient care Death Inappropriate public health action Undetected communicable disease

outbreaks Wasteful resources

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The non-conformity Cycle

INVESTIGATE

ACTIONCOMMUNICATE

AWARENESS

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The non-conformity CycleAWARE

INVESTIGATE

REMEDIATECORRECT

PREVENTIONMONITOR

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How are non-conformity detected?

Process MonitoringQuality control

L-J Charts

Management Review

Internal AuditSafetyQuality

External AuditPT/EQAAccreditation

Quality indicatorsDelayed reports

Interpretation errors

Monitoring complaintsand satisfaction surveys

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How are non-conformity investigated?

Information gathering Thorough investigation

Root cause analysis

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Root Cause Analysis

Structured investigations that focus on identify the

underlying true causes of occurrences.

Root Cause Analysis can lead to effective occurrence resolution.

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Root Cause Analysis Tools

Every cause has a deeper reason.

For each occurrence seek 5 levels of explanation before being satisfied as to the true (root) cause

MANPOWER EQUIPMENT

METHODS ENVIRONMENT

RESULT

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How are non-conformity Corrected?

Remedial Actions What are the immediate consequences of the

error that require amendment. What are the direct, secondary consequences

of the error the require amendment.

Corrective Actions What needs to be in place to prevent this

error from happening again?

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Non-conformity Management

Learn from the eventand avoid its recurrence

PreventiveActions

Corrective Actions

RemedialActions

See the potential eventand plan to avoid it

Address the eventand its consequences

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Preventive Actions

Preventive actions are planned Preventive actions require team

participation Preventive action tools take into

consideration: Probability Safety Risk

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Non-conformity Management Process

Develop a system for prompt investigation of every laboratory problem and error:

1. Establish a process to detect all

problems Remember that you may not be aware of

problems unless you look for them2. Keep a log of all problem events 3. Investigate causes, analyze information

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Non-conformity Management Process

4. Take corrective action5. Keep records of findings and action in log6. Observe for recurring problem – systemic7. Provide information to those affected by

the problem or error

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One example of a

non-conformity Management Form

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Quality Monitoring Tools

Process Monitoring

Management Review

Internal Audit

External Audit

Quality indicators

Monitoring complaints

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In summary…The non-conformity Cycle

AWARE

INVESTIGATE

REMEDIATECORRECT

PREVENTIONMONITOR