1 accreditation and certification: definition certification: procedures by which a third party...
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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
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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