Transcript 5 Assessment Process

CPA is a UKAS
company
The Assessment Process
2014 Seminars
The Assessment Process
• Application information
• Resource requirements
• Preparation for the assessment
• The assessment - on the day
• Reporting and improvement actions
CPA is a UKAS
company
Accreditation
CPA is a UKAS
company
• ISO/IEC 17000: 2004
Third-party attestation related to a conformity assessment body
conveying formal demonstration of its competence to carry out
specific conformity assessment tasks
In simple terms…..
CPA is a UKAS
company
• Providing confidence that a body can provide reliable,
reproducible outcomes that are fit for purpose
• Expectation that one will get the ‘right’ result and a reliable
outcome
Purpose of Assessment
CPA is a UKAS
company
• Can you demonstrate your competence?
• Has competence been maintained since the last assessment
– Records, minutes, feedback, complaints
• Are you still competent now?
– Witnessing, interviewing, questioning
• How will you maintain competence in the future?
– Effective & compliant Quality Management System
Application Information
• UKAS Application Form
• AC4 Form
• UKAS Agreement and supplement
CPA is a UKAS
company
AC 4 Form
•
CPA is a UKAS
company
Scope of activity – repertoire, equipment and location
MEDICAL
LABORATORY FIELDS
TYPES OF
EXAMINATION/TECHNICAL
FIELDS/ACTIVITIES (PLEASE GIVE
GENERAL HEADER FOLLOWED BY LISTING
OF ALL ANALYTES ETC)
*LOCATION
MATERIALS OR PRODUCTS
TESTED
DESCRIPTION OF EQUIPMENT
USED AND MEASUREMENT
PRINCIPLE
EXAMPLE
EXAMPLE
EXAMPLE
EXAMPLE
EXAMPLE
Microbiology
Therapeutic drug monitoring –
antibiotics
- Gentamicin
Blood
‘Manufacturers’ Analyser and
Enzyme-multiplied
immunoassay
Remote
‘spoke’ at
Medtown
Blood
‘Manufacturers’ Analyser and
photometry
GP (two
sites) and
Theatres
at main
hospital
*Blood Sciences
POCT –Haemoglobin
AC 4 Form
CPA is a UKAS
company
• Identification of other activities that support the functioning of
the laboratory and where these activities are conducted e.g.
facilities management, HR, Procurement etc
• Identification of activities outside of the scope of ISO 15189
• Details of in-house calibration activities
• Details of locations
Schedule of Accreditation
Blood – Ammonia -
CPA is a UKAS
company
SOP xxx using
Ammonia Checker
II/A-4120
Application Review
CPA is a UKAS
company
• Application information will be reviewed
• Additional information may be requested
• Decision will be made on the expertise and time required for the
assessment taking into account:
– Repertoire
- CPA history
– Locations
- Size of operation
– Other activities
Assessment Team
CPA is a UKAS
company
• Application review will determine team and duration
• Assessment Manager plus Technical Expert – some could be
involved remotely, before or after on-site assessment – all
trained in ISO 15189
• UKAS Observer – to monitor and review
Assessment Preparation
CPA is a UKAS
company
• Provision of additional information from the lab is likely
– Gap analysis – specific issues
– System documentation and procedures
• UKAS will provide a visit plan
– Timetable for the assessment
– Indicate what activities will be assessed and ‘witnessed’
The Assessment (1)
CPA is a UKAS
company
• Planned in advance to cover ISO 15189 (and CPA) requirements
• Assessment team will be prepared
• There will be a consistent approach but it will not be uniform
• Tasks will be allocated to Assessment Team members as per
plan
• May need to deviate from the plan
The Assessment (2)
• Opening Meeting
• Assessment Manager will act as the Lead Assessor
• Lead Assessor will focus on:
– Gap analysis outcomes
– Management System incl. supporting activities
– Coordinate technical experts
CPA is a UKAS
company
The Assessment (3)
CPA is a UKAS
company
• Technical Experts:
– Allocated tasks covering the process from sample receipt to
‘reporting’/post examination
– May use reporting forms but not checklists
– Will assess aspects using horizontal and vertical techniques
– Evidence based assessment – ‘show me’
The Assessment (4)
CPA is a UKAS
company
• Objective statements will be used to record any potential
nonconformities or opportunities for improvement, assessor will
ensure that the statements are factual and agreed with lab
• Assessment team will determine whether finding is a
nonconformity:
– ‘M’ – mandatory findings – action needed
– ‘R’ – recommendation
Assessment (5)
CPA is a UKAS
company
• Findings will be discussed at the time they are
identified/recorded
• Potential corrective actions may also be discussed and
specified
• Related findings can be combined (may assist in highlighting
any gaps)
• Summary provided at closing meeting
Assessment Report
CPA is a UKAS
company
• UKAS reporting and assessment procedures are given in Lab 3
and Gen 3 (www.ukas.com)
• Main report prepared by Lead Assessor with input from all of
the team
• Currently the report is structured around the following
headings: Scope, Organisation, Management, Evaluation
Processes, Technical Competence and Impartiality & Integrity
Next Steps
Usual UKAS process:
• Recommendation
• Timescales for clearing findings
• Mechanism for clearing findings
CPA is a UKAS
company
What to expect…
CPA is a UKAS
company
•
Scoping and hence coverage of the scope at the assessment
•
Increased planning and up front preparation
•
Different ‘routine’ in the assessment but plan will provide
details
•
Impact of the different requirements e.g. decreased focus on
H&S
•
Evidence based approach
What to expect…..
CPA is a UKAS
company
• Focussed discussions on key differences such as traceability,
validation etc
• To demonstrate how you meet the requirements
• The assessment will focus on outcomes
• Assessment will seek to demonstrate that accreditation can be
granted……remember what accreditation is expected to deliver
CPA is a UKAS
company
The Assessment Process
2014 Seminars