Insights into Quality Assurance Auditing

Quality Assurance From The Eyes of An Auditor Dwyane Sheppard, M.Ed., CCRP Clinical Trials Auditor

Objectives 1. To Discuss and Identify Best Practices Learned From Conducting Audits 2. To Help Improve Study Conduct From Lessons Learned By Implementing Internal Quality Assurance Practices

Quality assurance can be defined as "part of quality management focused on providing confidence that quality requirements will be fulfilled." Definition of Quality Assurance

To implement a continuous quality improvement program/process that utilizes accuracy, consistency, collaboration, and communication to improve, create, develop and maintain a workplace culture of compliance My Objective As An Auditor *** Should be in line with your departmental, institutional, federal, and state regulations and guidelines

Consistency Communication Components of Quality Assurance Collaboration Correctness

Have a standardized process of what you do and how you do it. Develop Standard Operating Procedures (SOP s) Consistency: Develop a consistent training/education program Enable study team to share a common and uniformed view of the ultimate goal. Internal/External customers will know what to expect each time (creates trust)

Consistency (con t): How to Maintain 1. DEFINE YOUR QUALITY EXPECTATIONS FOR THE PROJECT 2. COMMIT TO THOSE QUALITY EXPECTATIONS 3. MANAGE FOR QUALITY 4. CONTROL THE QUALITY 5. DOCUMENT LESSONS LEARNED

How well you utilize effective means of interaction with your customers. Ensure all involved understand the goals in mind Provide feedback (constructive) Communication Cross training of roles, responsibilities of study related tasks Be transparent Develop a point of contact to disseminate milestones, setbacks, etc

How well you work with internal/external customers Helps to have 1-2 points of contact Invite some of those collaborators to team meetings/trainings Collaboration Respond to inquiries in a timely manner Be professional ; titles do not make us professional, our mindset does Enhance team members engagement (gives team member autonomy) Improve quality indicators across the board

Collaboration (cont) Cultivates openness and transparency Creates a place where ideas can be shared Improves relationships across departments.

Correctness (accuracy): results conform to the standard How well you record what you have done How well you report what you have/have not done Overtime improves attention to detail Lends to more validity and reliability of the data collected How well you monitor what you have done Overtime improves cohesiveness of the team

1. Team members must take ownership of their role in the research project 2. Measure the team member s ability or desire to make decisions (out of the box thinking not defined by an SOP/policy) Empowerment In Relation To Quality 3. Team member recommends what works (solution oriented): I.D.E.A.S. I-Ingenuity D- Decisiveness E-Engagement A- Alignment with goal/goals S- Share with others 4. Allows the ability to accept feedback without internalizing as negative or fear of being punitive. 5. Improves morale (your stake in the success of the project)

Behavioral Factors Related To Empowerment (Quality Improvement) Sometimes we are so focused on systems regarding process improvement (quality), that the human factor is not accounted for. We move to change or do away with a system(s) we created with haste, that we generally do not account for the individuals implementing the system (s) created

Behavioral Factors (cont): Intangibles TRUST- BE ABLE TO SEE AND EXPECT OF YOURSELF WHAT YOU SEE AND EXPECT OF OTHERS MOTIVATION; BE INTENTIONAL ABOUT YOUR COMMITMENT AND WHY- BE DELIBERATE MAKE A SELF- ASSESSMENT ABOUT YOUR ABILITIES- HOW WELL WERE TRAINED WEATHER-MAN MINDSET- ABILITY TO FORECAST ANTICIPATE ISSUES, DESIRED OUTCOMES SCENARIO-BASED LEARNING AND IMPLEMENTATION VALUES- INTRINSIC NEED TO IMPROVE, SELF AWARENESS, BELIEF SYSTEM **WE SHOULD TRAIN OUR MINDS TO ANTICIPATE PROBLEMS/ISSUES TWO-WAY MIRROR

Standardization In Quality Talk the same language when communicating outside your department about department processes Be clear/concise/comprehensive This decreases errors and improves efficiency Form of protection: for Institution, Staff, and partners Creates a solid foundation to build upon

Value Of SOPs Should be a reflection of tasks relevant to your department/institution Serves as points of reference on how to perform those tasks Always subject to changes/modifications/ amendments If you say you are doing something indicated in an SOP you have to prove it and there is an obligation to follow the SOP. SOP s says what you will do not what you won t do?

CAPA: Purpose is to collect information, analyze the information, identify and investigate the problem, and take appropriate and effective corrective and/or preventive action to prevent recurrence Collect Value of CAPAs: Corrective and Preventive Actions Corrective Action: Focus on implementing changes to an identified existing breach in a process or system Focus on Preventive Action: Focus on eliminating the cause for any potential breaches in a processor system Focus on

Benefits Of An Internal QA Program PREPARES FOR AUDITS (FDA, CRO, SPONSORS ETC) ALLOWS YOU TO IDENTIFY AN ISSUE BEFORE IT BECOMES AN ISSUE BRIDGES GAPS ACROSS DEPARTMENTS OPPORTUNITIES FOR IMPROVEMENT CREATE METRICS TO ENHANCE LEARNING/EDUCATION CREATE AN ENVIRONMENT FOR OUT OF THE BOX THINKING INCREASE THE LIKELIHOOD DATA COLLECTED IS AS CLEAN, RELIABLE, AND VALID AS EXPECTED.

Things Ive Seen: Consenting: authorized consenter, one signature vs two signatures, correct LAR, etc Incongruent database (EMR vs EDC) Adverse event reporting Be more proactive vs reactive: helps to create contingencies Regulatory (DOR, 1572, GCP/HSP, training) Documentation (explaining gaps)

Additional Support To QA Program DATA SAFETY MONITORING BOARDS CLINICAL RESEARCH MONITORING SCIENTIFIC REVIEW COMMITTEES INTERNAL MONITORING COMMITTEES INSTITUTIONAL REVIEW BOARDS

QA Program: Things To Consider Use information learned from your internal QA program and develop metrics to use as training tool Minimize the use of Note To Files: Consider CAPAS Look at how to bridge gaps in communication between groups QA is not punitive: a tool for process improvement Gives opportunity to have a fresh set of eyes to look at things Makes you more proactive about a culture of quality Focus on what your expectations are from the onset

Comprehensive Quality Assurance Becomes Intentional Quality Compliance & Intentional QC Becomes Comprehensive QA * Proper Preparation Prevents Poor Performance *Consistency, Communication, Collaboration