how to implement qms in a fertility centre
TRANSCRIPT
Sandro C. Esteves
ANDROFERT, BRAZIL
L6: How to implement QMS in a fertility
center
IVF Preceptorship Hamburg, 4-5 July 2014QMS in the Fertility Centre
ISO 9001:2008
Learning objectives
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At the completion of this presentation, participants should be able to:
• Understand what QMS stand for • Understand the basic concepts of ISO
9001 as a model for QMS to fertility centers
• Learn how we implemented ISO 9001:2008 at Androfert and how to adapt what we did to your own center
o It varies from person to person, and it’s influenced by feelings
o Despite being a relative concept, it cannot be established in a vacuum
o Always relative to a set of requirements
Quality issubjective…
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Quality is how well the output of our processes comply with a set of pre-
defined requirements
Process = Any activity or set of activities that uses resources to transform raw material, supplies and labor (inputs) into products or services (outputs)
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A set of coordinated activities to direct and control an organization to continuously improve the effectiveness and efficiency of its performance
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Activitiescontinuously improve
performance
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QMS - ISO 9001:2008Determine needs and expectations of customers and others (legislation, professional societies, etc.)
Mission
Establish a quality policy, quality objectives, and quality indicators for the organization
QM focus
Determine processes/procedures to achieve the quality objectives; Identify and provide necessary resources
Process
Determine means to prevent nonconformities (NC) (variation) and eliminate their causes; Register quality actions; Verify compliance (auditing)
NC; Registering; Auditing
Establish and apply methods to measure effectiveness/efficiency of each process
Monitoring
Establish and implement a process that involves all personnel for continual improvement
Continual improveme
nt
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ISO 9001:2008 - QMSDetermine needs and expectations of customers and others (legislation, professional societies, etc.)
Mission
Establish a quality policy, quality objectives, and quality indicators for the organization
QM focus
Determine processes/procedures to achieve the quality objectives; Identify and provide necessary resources
Process
Determine means to prevent nonconformities (NC) (variation) and eliminate their causes; Register quality actions; Verify compliance
NC; Registering; Auditing
Establish and apply methods to measure effectiveness/efficiency of each process
Monitoring
Establish and implement a process that involves all personnel for continual improvement
Continual improveme
nt
Express
es the org
anizatio
nal
stru
cture
, polic
ies,
proce
dures,
proce
sses a
nd
reso
urces n
eeded to
implement q
uality
management
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Key points (1)
Quality is relative to a set of requirements how well the output of our processes comply with pre-defined requirements
QMS: coordinated activities to direct and control an organization to
continuously improve the effectiveness and efficiency of its performance
expresses organizational structure, policies, procedures, processes and resources needed to
implement quality management
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How to implement QMS in a fertility center
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1. Create your mission statement
Define who your clients areWHODefine what services you provide
WHAT
Define your methods, philosophy, objectives, etc.
HOW
Our mission is to help couples with conception difficulties become parents, especially when the difficulty is partially or totally related to
men, through counseling, diagnosis and treatment, offering personalized professional service of excellence, and using all available
technologic resources
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2. Define your QM focusBrief, simple and direct statements that define top management’s commitment to quality (general quality orientation and basic intentions)
Quality Policy
Goals of each quality policy (they have to be measurable)
Quality Objective
s
How you monitor your quality objectives (tools to check if your objectives, and therefore your policies are being achieved)
Quality Indicator
s
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QM
Focu
s
3. Describe your processes and procedures
Any activity or set of activities that uses resources to transform raw material, supplies and labor (inputs) into products or services (outputs) P
rocess
Sequence of steps to execute a task
Important for standardization and replication
Pro
ced
ure
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Standard Operating Procedure (SOP)sequence of steps that have been standardized to execute a task, which is used every time a given task is done, to ensure it is done the same way each time
Detailed instructions to achieve uniformity on the performance of a specific
procedure
Usually written and hierarchical, but also expressed as flowcharts or drawings
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Top 5 reasons why Fertility Centers need SOPs
1. Repetitive highly-complex critically important tasks
2. Variation must be controlled3. More than one person could
perform the same task4. Safety risks are present5. Quality control needs to be
ensured
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Lab SOP key pointsI. General information:• Name of test or procedure• Principles (goals and general information)
II. Pre-analytic information:• Patient instruction for test/procedure
preparation• Specimen collection instructions • Specimen labeling, transport, referral• Specimen acceptability (including rejection
criteria)
III. Analytic information:• Equipment, materials and reagents• Conditions required (e.g. laminar flow
cabinet)• Instrument calibration and verification• Quality control (negative/positive control if
required)• Step-by-step procedure description• Assay/procedure performance limitations • Troubleshooting
IV. Post-analytic information:• Calculations (if
required)• Normal ranges
(reference intervals or expected results)
• Policy for handling alert or panic values
• Report• References
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Document Control Quality Manual
– Describe document control system– Documents must be reviewed and
authorized– Audit & update quality documents
annually – SOP for retention and storage of
records– SOP for control of archive
documentationTechnical Manual
– Master list of documents and retention times
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Tech
nic
al M
an
ual
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Clinical NeedsDetermine
tests/procedures
Write SOP
Does it provide information for
clinical decision?
What does the doctor need
to know?
Designing SOPs
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Designing a SOP - Example
How can I avoid
unnecessary surgical sperm
retrieval in men with
NOA?
Semen analysis at day
of sperm retrieval
Presence of sperm for
ICSI
What does the doctor need to
know?
Determine test
Lab SOP with post-analytical
info for clinical
decision
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How can I avoid
unnecessary surgical sperm
retrieval in men with
NOA?
Semen analysis at
sperm retrieval day
Presence of sperm for
ICSI
Does SOP provide solution for panic/alert values?
Panic value: No sperm
What to do next? eg.: Centrifugation
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Clinical decision based on Lab SOP
information
Key points (2)
1. Explain why the organization exists2. Create quality policies to generate
quality objectives; they serve as a general framework for action
3. Define all processes needed to meet a desired outcome
Design workable SOPsImplement, control (verify
conformity) and improve (update) SOPs
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4. Training personnelGetting to know each other
each sector presents who they are, what and how they
work
Interdepartmental observations
provides a realistic view daily work activities
Internalizing ethical and moral values
understand their individual roles and importance within
the organization
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QM training
4. Training personnel (cont.)
4. Training personnel (cont.)
Initial and recurrent training clearly outlined
SOPs are key elementsStaff performance periodically evaluated
Feedback given
Continual training program established
cover both new training as well as reviewing concepts and procedures, to guarantee internalization
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Personnel & TrainingSummary
• Job descriptions• Personnel policies• Induction training• Professional qualifications• Competency testing• Responsibilities clearly defined• Training/ retraining• Informed of ethical issues/moral
values
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Infrastructure
Entire system of facilities, equipment, and services that a fertility center needs in order to function
BuildingsWorkspacesEquipment hardware & software
Support services
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5. Register quality actions
Actions taken to improve the service provided
Improvement Actions
Actions taken to avoid a potential non-conformity before it actually happen
Preventive Actions
Actions taken after detecting a non-conformity to correct it
Corrective Actions
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Non
-con
form
itie
sEvery deviation from what is established.
Identify inconsistencies, weaknesses, and improvement opportunities
Implement a culture of reporting
NC, preventive action, improvement opportunity
Electronic-based records
Data collection more uniform
5. Registering (cont.)
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6. Auditing
Verify conformity
Main
O
bje
cti
ve
Processes, Procedures, Documents and Records
Typ
es
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7. Information
Quantify and evaluate the organization’s success;
Measure how much progress you’ve made relative to the objectives you wish to achieve;
Critical to make improvements and support decision making.
Main
ob
jecti
ves
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8. Continual improvement
Set of recurring activities carried out to enhance the ability to meet requirements
• Audits (internal & external)
• Self-assessments• Management reviews• Implement corrective
and preventive actions• Improvement group
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8. Continuous improvement (cont.)
Fabiola Bento, MBAQuality Manager, ANDROFERT
Quality managerEstablish unity of purpose and direction of the internal environment
Create an environment where people are fully involved in achieving the organization’s objectives
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Key points (3) How we implemented
1. Taught the ISO standard to the whole team
2. Engaged the management team so that their work reflected the new concept and was used as an example for the rest of the team
3. Identified the processes and procedures involved in the realization of our service
4. Standardized all procedures necessary to offer the service we provided, writing SOPs and training our team
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5. Created ways to control (internal auditing) and guarantee SOPs were being followed without variations
6. Defined and monitored key performance indicators to improve the quality of services provided
7. Formally documented the implemented system
8. We were surveyed and ISO certified
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Key points (3) How we implemented
“The real voyage of discovery consists not in seeking new landscapes, but in having new eyes.”
Marcel Proust
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