aphl quality manager series preconference workshop for what a quality manager should know quality...
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Checklist for What a Quality Manager Should Know
Quality Manager Pre-Conference WorkshopJune 11, 2017
APHL Annual MeetingProvidence, RI
Jill J. Power, MS, M(ASCP), CMQ/OE(ASQ)Biosafety Officer/Quality Coordinator
NH Public Health LaboratoriesConcord, NH 03301Tel: 603‐271‐5869
LSS Committee Objectives
• Quality driven • Standardizing internal and external
processes• “Think Tank” for APHL • Assist member labs in developing and
training quality leaders and champions• Create deliverables
APHL Quality Manager
• Quality manager position description o KSAso Competency tool
• Roles & Responsibilities
• Regulations
• CLSI QSEs
• ASQ Checklist
Regulations• A2LA – American Association for Laboratory
Accreditation• AIHA – American Industrial Hygiene Association• CLIA – Clinical Laboratory Improvement Amendment• CAP – College of American Pathologists• EPA – Environmental Protection Agency• FDA – Food & Drug Administration• ISO – International Organization for Standardization• NELAC – National Environmental Laboratory
Accreditation Conference• TNI – The NELAC Institute• USDA – United States Dept. of Agriculture
Clinical Laboratory Standards Institute Quality System Essentials
Certified Quality Manager (ASQ)
• Leadership• Strategic Plan Development and Deployment• Management Elements and Methods• Quality Management Tools• Customer‐Focused Organizations• Supply Chain Management• Training and Development
I. Leadership
• Organizational Structures and Culture• Leadership Challenges• Teams and Team Processes
II. Strategic Plan Development & Deployment
• Strategic Planning Models• Business Environment Analysis
o SWOT Analysis• Strategic Plan Deployment
III. Management Elements & Methods
• Management Skill and Abilities• Communication Skills and Abilities• Project Management• Quality System• Quality Models and Theories
IV. Quality Management Tools
• Problem‐Solving Tools• Process Management• Measurement: Assessment and Metrics
• Customer Identification & Segmentation• Customer Relationship Management
VI. Supply Chain ManagementVII. Training and Development
V. Customer – Focused Organizations
SWOT Analysis
S – StrengthsW – WeaknessesO – OpportunitiesT – Threats
Quality Management System(QMS) SWOT
• What does your laboratory’s QMS look like?• What could be improved?• What is lacking?• Why is it so great?• How could it be wiped
out/destroyed/undermined?
Writing a Quality ManualWhat the Quality Guru in Your Laboratory Should Know
Quality Manager Pre-Conference WorkshopJune 11, 2017
APHL Annual MeetingProvidence, RI
Karen Sanderson, BHS, MT(ASCP)SCQuality Assurance Manager
North Carolina State Laboratory of Public Health1918 MSC
Raleigh, NC 27699‐1918Tel. 919‐807‐8747
What is a Quality Manual?• Provides laboratory leadership, personnel, and assessors with a
description of the laboratory’s Quality Management System (QMS).
• Provides the intent for how the laboratory will:o Ensure Qualityo Practice good quality managemento Implement requirements consistently across all lab operationso Meet regulatory, accreditation, and customer requirements.
• Defines and documents a laboratory’s system for managing quality by compiling policies, processes and procedures for the QSEs.
• Includes non‐technical documents generated and received by the laboratory that specify requirements for activities other than pre‐examination, examination, and post‐examination work processes.
Adapted from: CLSI QMS25 Handbook for Developing a Quality Manual, 1st ED (2017) and WHO Quality Manual Template (2013)
The 4 Levels of Documentation
Make It Your Own• Customize it: no one format fits every lab’s
needs• Content, format and structure vary depending on
lab size and test complexity• Separate manuals for clinical and environmental or
one manual for all or hybrid?• Add documents under each QSE or at end as
appendix?• Use links to documents or paper copies?
Contents of a Quality Manual• Title Page• Table of Contents• Introduction• Acronyms/Abbreviations• Definitions• Quality Goals and Objectives• QSEs (Quality System Essentials) used like chapters in your Quality Manual arrange the order to fit your facility and scope.
• Appendices
Introduction: items to consider
• Scope and purpose of Quality Manual
• Brief overview of laboratory, location, relation to parent organization, hours of service
• Short summary of each lab unit/discipline.
• Mission and Vision
• Certifications and Accreditations
• Quality Policy
• How Quality Manual will be maintained, reviewed, and updated
Quality Policy Example“Senior management is dedicated to providing the resources necessary to maintain the laboratory quality management system and to ensure the laboratory’s participation in the institutional quality plan.
The laboratory is committed to continual improvement, meeting internal requirements and customer requirements, and providing a basis for the establishment and review of the quality objectives.
Quality practices are communicated within the organization, understood an adhered to all by all employees
The laboratory ensures a competency workforce to deliver quality results in a timely manner according to the …..”
WHO Quality Manual Template (version 2013)
Quality Goals and Objectives• Goals are broad statements of accomplishments that
leadership expects to achieve (e.g. improve customer service)
• Objectives are more specific statements that are SMART (specific, measurable, achievable, relevant, and timebound), e.g. reduce TAT for XYZ assay results by 20% within next 3 months.
• Use metrics and thresholds to measure (Quality Indicators)
• Evaluate and update/revise annually• May be valuable to attach in an appendix or as separate
document
The CLSI QMS Model
The Quality Management System Model (CLSI QMS01)
• Organization• Personnel• Equipment• Facilities and Safety• Purchasing and Inventory
• Information Management
• Documents and Records
• Non‐Conformance Management
• Assessments• Process Improvements• Customer Service• Process Management
QSEs: Building Blocks of a QMS and Sections in the Quality Manual
Regulations Cross-walk(updated 2017)Sorted by QSEProvides Regulation References to the following:ISO 17025:2005(E) 40 CFR 151, 2012‐07‐01
ISO 15189:2012 ABFT
DW Manual (EPA 815), 2005 ASCLAD/Lab Supplemental
CLIA, January 24, 2003 AAVLD
AIHA 2017, AAFEO
TNI, 2009
9 CFR Food Safety and Inspection, 1/2014
Resources:• How to Write a Laboratory Quality Manual, APHL,
May 2017• QMS25 Handbook for Developing a Laboratory
Quality Manual, CLSI, 2017• World Health Organization (WHO)/CLSI: Supplement
to the Laboratory Quality Management System Training Toolkit, Quality Manual, Version, 2013http://www.who.int/ihr/training/laboratory_quality/quality_manual/en/
Conducting Internal AuditsQuality Manager Pre-Conference Workshop
June 11, 2017APHL Annual Meeting
Providence, RI
Yvonne Salfinger, MS, MT(AAB)APHL Consultant
Retired Chief, Bureau of Food LaboratoriesFlorida Department of Agriculture and Consumer Services
[email protected]‐233‐6710
Components of Internal Audit Plan• Purpose and scope
• Activities to be audited
• Reference requirements (i.e. regulatory, accreditation, internal policy, etc.)
• Assigned auditors
• Schedule
• Sampling plan
• Report of findings (Nonconforming activities/actions)
• Quality function approval and date
• Effectiveness of actions (over time) and of internal audits
• Tracking/monitoring
Why do we have to do audits?Compliance with internal policy, regulatory and accreditation requirements such as:• CLIA ‘88 493.1239• ISO 15189:201 clause 4.14• ISO/IEC 17025:2005 clause 4.14• CLSI QSEs Assessments• The NELAC Institute (TNI) 2009 4.14
Why do we have to do audits?• Follow‐up in response to a complaint, external audit
findings, or nonconforming event• To ensure a new method is compliant with
regulatory requirements• To verify compliance with the quality management
system• Analytical methods, SOPs, Quality Manual,
internal and external policies (ethics, data integrity), customer requirements
Why should we do audits?• Aids in identifying opportunities for
improvement and preventive actions• Helps in determining the effectiveness of
quality improvement projects, corrective actions• Can help to find sources of waste• Can help to reduce or prevent recurring
issues• Provides information for quality planning
• Assess effectiveness of actions• Prioritize follow‐up actions• Allocate resources• Identify training needs
Range of view of the audit• Ensuring appropriate test procedures, equipment, controls, calibrations are established and used
• Ensuring appropriate laboratory tests are ordered
• Procuring samples timely and efficiently• Disseminating test information to providers/clients in a timely, accurate manner
• Utilizing qualified laboratory personnel (i.e. training, competency)
Scope of Audit
Types of AuditsSystem audit
• Verifying system requirements• Prospective or retrospectiveExample: Document system audit‐creation, revision, control, review, archiving
Process audit• Verifies that actions, inputs and outputs are occurring as
intended• Follows process from beginning to end
• Forward or backwardsExample: Preanalytical audit‐sample receiving, accessioning, storing, retrieving (could be sampling also if applicable)
Types of AuditsProduct or service audit
• Audit of whether a product or service meets specifications
• “Focused audit”‐narrow scope
Examples:
‐Review of final test reports‐verify all required information
‐Review of actions taken for a complaint
‐verify appropriateness and completeness of action
‐ verify policy and procedures are adequate
‐ verify they are followed
Activities to be Audited• Preanalytical
• Logs• Policies and procedures
• Analytical• Logs• Run data• Proficiency tests• Policies and procedures‐Are they present?
• Postanalytical• Quality system parameters, e.g., non‐conforming
events and actions• Report completeness• Turnaround times• Policies and procedures
Reference Requirements“Say what you do
and
do what you say”
Where does it say we do these things?Do we have a gap (i.e. no policy or procedure?)Do we do what we say (i.e. follow the SOP?)
Reference RequirementsAudits can also be conducted due to triggers such as:• Trends in nonconforming events• Effectiveness of corrections• Assessment of baseline status prior to a
change being implemented• Ideas from personnel or management
• Must be trained and qualified prior to conducting audit• Training can be internal or external; experience documented• APHL Resourceshttps://www.aphl.org/programs/food_safety/laboratory‐accreditation/Pages/ISOIEC‐17025‐Accreditation‐Training‐Resources.aspx
• Preferably is independent of activity to be audited
• Plans and schedules audits (if a team, a lead auditor may be assigned; forms team and provides assignments to team members)
• Reviews prior information (audits, reports)
• Performs audit• Reviews documents and records• Asks objective questions (What is your process?)
• Completes audit report• Reviews report with management• Discusses findings and answers questions
Auditor
Scheduling• Audits should be on a published schedule• Schedules may be dictated by customer,
regulations, or internal policy• Can choose to audit small parts every month,
or full audit periodically
Sampling PlanHorizontal audits‐capture process from beginning to end (Process audits)‐can choose number of records per sample type/per section/per day/% total reports
• Sample tracking‐forward or backward• Nonconformance program
Vertical audits‐deep look into specific process‐follow flowchart, table, written SOP
• Sample receipt and login• Turnaround time
Desk audit• Collect laboratory’s policy, process procedure documents for the
scope of the audit• Compare documents to reference requirements (be sure to add
this requirement to the audit report)• Can be pre‐audit tool for other scopes
or can be stand alone
Audit QuestionsObjective evidence is documented
• What is documented process for receiving and handling samples in the laboratory’s sample receiving section?
• Are there written procedures?• Are they current?
• How are the personnel training in the process?• Are there records?• Are they complete?
• When and how is personnel competence assessed?• Are there records?• Are they complete?
• Do personnel follow approved procedures without deviation?• Observation• Any potential improvement areas?
Report findings, auditee response1. Reports may be dictated by regulating bodies/checklist
2. Verbal report‐positive findings, any non‐conformances, standard/documentation such as policy for non‐conformance and objective evidence
3. Written report‐date(s) of audit, names of individuals who participated in audit, summary of findings with standard cited, summary of potential improvements
4. Reports must be timely, courteous and professional, standardized format
Auditee response:
1. For non‐conformances, detail corrections and corrective action, including root cause analysis
2. Proof of commitment, i.e. documented changesif non‐conformance found and evidence of compliance
Example worksheet
Example worksheet
Example worksheet
Both forms:Thanks to FloridaDepartment of Agriculture andConsumer Services,Bureau of Food Laboratories!
Could use a “audit” copy of the actual SOP to followmethod and make notes on it as part of the audit package.
Effectiveness of actions/Tracking/Monitoring1. Nonconformances should be corrected within
corrective action process, which requires effectiveness of actions taken
2. Tracking and monitoring for trends should be reviewed at Management Review
3. Effectiveness of audits should be evaluated too.4. Don’t forget to look for ways to improve!!
References:• Laboratory Internal Audit Plan, APHL, May 2017
• Lucia M. Berte, lecture material APHL Workshop, How are we doing? Laboratory Internal Audit Program, February 15‐16, 2017, Denver, CO
• Florida Dept. of Agriculture and Consumer Services, Bureau of Food Laboratories, Tallahassee, FL
Resources:• QMS15:2013 Laboratory Internal Audit Program, CLSI
www.asp.org/quality‐press
• The ASQ Auditing Handbook, Russel JP, 4th edition
• Quality Audits for Improved Performance, Arter DR., 3rdedition
• The Internal Auditing Pocket Guide, Russell JP
• Certified Quality Auditor Primer, 8th edition. Quality Council‐www.qualitycouncil.com
Resources:• APHL ISO/IEC 17025 Accreditation Training Resources
https://www.aphl.org/programs/food_safety/laboratory‐accreditation/Pages/ISOIEC‐17025‐Accreditation‐Training‐Resources.aspx
Resources:• APHL Member Accreditation Resources
• https://www.aphl.org/programs/food_safety/laboratory‐accreditation/Pages/Accreditation‐Resources.aspx
Resources:• APHL Member Accreditation Resources‐Internal audits
Login required, no membership required but should be a state or local food/feed testing laboratory (i.e., no industry allowed)
QUESTIONS?