THE INCONVENIENCE OF BATCH RECORDS IN A STERILE ENVIRONMENT ARE THERE DEEPER CONCERNS?

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2 THE INCONVENIENCE OF BATCH RECORDS IN A STERILE ENVIRONMENT ARE THERE DEEPER CONCERNS?

3 Major Risks and Control Categories Processes Equipment Systems People Predictable Results

4 Human Error Risk Controls Technical Behavioral Procedural

5 Human Error Troubleshooting Guide Human Dilemma Root or Contributing Causes Risk Control Elements Unclear task definition Unclear or competing priorities Uncertainty on how to proceed Ambiguity re: responsibility or authority to proceed Insufficient or inaccessible guidance Unclear expectations for role; lack of process knowledge; poor or inaccessible SOPs Misaligned priorities within leadership levels; lack of communication or support, lack of supervisory skill Poor system / process knowledge; lack of leadership support; lack of OJT; poor or inaccessible SOPs Poor workplace communication; lack of escalation clarity; poor system / process knowledge Poor or inaccessible SOPs; lack of cultural accountability Clear job descriptions, effective SOPs, role qualification emphasizing process KSA Full alignment on responsibilities and priorities at all levels; supportive leadership structure; leader development Supportive supervisors and leaders; effective qualification program that emphasizes system / process KSA Clear job descriptions; RACI and escalation processes; encouraging leadership environment SOP assessment / revision; compliance assessment

6 COMPLACENCY IN ACTION WHERE IS THIS BEHAVIOR ROOTED?

7 Human Error Troubleshooting Guide Human Dilemma Root or Contributing Causes Risk Control Elements Unclear task definition Unclear or competing priorities Uncertainty on how to proceed Ambiguity re: responsibility or authority to proceed Insufficient or inaccessible guidance Unclear expectations for role; lack of process knowledge; poor or inaccessible SOPs Misaligned priorities within leadership levels; lack of communication or support, lack of supervisory skill Poor system / process knowledge; lack of leadership support; lack of OJT; poor or inaccessible SOPs Poor workplace communication; lack of escalation clarity; poor system / process knowledge Poor or inaccessible SOPs; lack of cultural accountability Clear job descriptions, effective SOPs, role qualification emphasizing process KSA Full alignment on responsibilities and priorities at all levels; supportive leadership structure; leader development Supportive supervisors and leaders; effective qualification program that emphasizes system / process KSA Clear job descriptions; RACI and escalation processes; encouraging leadership environment SOP assessment / revision; compliance assessment

8 Rules of Human Performance Control 1.All humans are fallible. 2.Most humans want to perform good work. 3.You can set conditions for people to succeed.

9 Behavioral Spectrum Carelessness Misguided Decision Poor Judgment Malfeasance

10 How did they do this? Careless error or omission Failed to follow procedure Purposeful omissions or deletions Repeated process or tests When does the method matter?

11 Instead, let s ask Why? Poor understand of cgmp Purpose* Practices Conscious decision to compromise quality Pressure* Misguided good intentions Poor understanding of cgmp

12 A MISGUIDED TEAM WHO IS TO BLAME?

13 Behavioral Spectrum Carelessness Misguided Decision Poor Judgment Malfeasance Distracted Unqualified Uncertain Unqualified Pressured Apathetic Pressured Greedy Malicious

14 Human Error Troubleshooting Guide Human Dilemma Root or Contributing Causes Risk Control Elements Unclear task definition Unclear or competing priorities Uncertainty on how to proceed Ambiguity re: responsibility or authority to proceed Insufficient or inaccessible guidance Unclear expectations for role; lack of process knowledge; poor or inaccessible SOPs Misaligned priorities within leadership levels; lack of communication or support, lack of supervisory skill Poor system / process knowledge; lack of leadership support; lack of OJT; poor or inaccessible SOPs Poor workplace communication; lack of escalation clarity; poor system / process knowledge Poor or inaccessible SOPs; lack of cultural accountability Clear job descriptions, effective SOPs, role qualification emphasizing process KSA Full alignment on responsibilities and priorities at all levels; supportive leadership structure; leader development Supportive supervisors and leaders; effective qualification program that emphasizes system / process KSA Clear job descriptions; RACI and escalation processes; encouraging leadership environment SOP assessment / revision; compliance assessment

15 Commonly Competing Priorities

16 THE IMPACT OF INSUFFICIENT QUALIFICATION WHAT ARE THE LARGER EFFECTS?

17 Workplace Performance Factor Guide Workplace Factor Description Impact Alignment of Purpose & Priority Role Clarity Co-worker Interactions Staff Development, Qualification, & Training Commitment to Improve Pay & Incentives Hiring and Role Selection

18 1. ALIGNMENT OF PURPOSE & PRIORITIES Reduced errors Procedural compliance Regularly reinforced communication Aligned priorities Description Meaningful mission & goals Alignment on priorities Accepted definition of success Impact + Inspired staff + Productivity - Silo departments - Dysfunction, chaos 18

19 2. ROLE CLARITY Description Goal is clear Clear expectations Support & escalation process My level of authority My Role Expectations for me My tasks to achieve goal My metrics Clear workflows toward goal Clear authority and escalation procedures Impact + Steady production + Error & delay control - Ambiguity, confusion, waste - Stress, exhaustion, apathy 19

20 3. INTERACTIONS * Accountability Trust & Respect Communication Description Regular & transparent communications Respectful, supportive climate Accountability at all levels Impact + Collaboration + Inter-department trust - Internal politics, rumors - Disengagement 20

21 4. DEVELOPMENT, TRAINING, & QUALIFICATION Description Operator Team Lead Qualified On-boarding Training Practical Experience Demonstrated Skill Supervisor Structured paths to qualify for roles / advancement Opportunity for skill & career development Impact + Quality & Productivity + Goal-driven staff - Apathy - Skill turnover / gaps 21

22 Qualification of Personnel Regulatory Requirements provide guidance: FDA 21CFR Training, education, and experience PIC/S Chapter 2, Sections Study Practice Perform Qualify 22

23 5. COMMITMENT TO IMPROVE Implement change Question current state Seek team insight Description Continuous staff involvement in process & workflow review Adequacy & usability of process, systems, & SOPs Leadership attitudes, support Grant creative authority Involve the right people Listen, absorb Impact + High quality work + Proud & productive staff - Disengagement - Communication gaps, silence 23

24 6. PAY & INCENTIVES Reward Burden Description Fair market value Consistent & dependable Clear expectations for advancement Impact + Valued staff + Loyalty - Bitterness - Turnover 24

25 6. PAY & INCENTIVES Reward Burden Description Fair market value Consistent & dependable Clear expectations for advancement Impact + Valued staff + Loyalty - Bitterness - Turnover 25

26 7. HIRING & ROLE SELECTION STANDARDS Description Standards for recruiting and selection Fair role assignment & advancement processes Impact + High performance standards + Peer respect - Resentment - Workload burden 26

27 Workplace Performance Factor Guide Workplace Factor Description Impact Alignment of Purpose & Priority Meaningful mission & goals Alignment on priorities Accepted definition of success + Inspired staff + Productivity - Silos, dysfunction Role Clarity Clear expectations Clear authority and escalation procedures Clear workflows to achieve goal Co-worker Interactions Communication regularity, transparency, & clarity Respectful, collaborative, supportive climate Accountability at all levels Staff Development, Qualification, & Training Structured paths to qualify for roles / advancement Opportunity for skill & career development Commitment to Improve Staff involved in regular process & workflow review Process, systems, & SOP adequacy & usability Leadership attitudes / support toward change Pay & Incentives Fair market value, consistent & dependable Clear expectations for advancement Hiring and Role Selection Standards for recruiting and selection Fair role assignment & advancement processes + Steady production - Confusion, waste - Exhaustion, apathy + Team collaboration + Inter-dept. trust - Internal politics, rumors + Quality & Productivity + Goal-driven staff - Skill gaps, apathy + Quality & efficiency + Staff pride - Disengagement, silence + Valued staff, loyalty - Bitterness, turnover + High standards + Peer respect - Resentment or burden

28 Who has time or money to spend setting ideal work conditions? Deviation Cost Categories Delays & Downtime Rework Investigation Time (Operator / Technician, Investigator, Expert, Quality, Management) CAPA & Effectiveness Checks Rejected Product Regulatory Scrutiny Range: $25,000 - $54,000 per deviation Control Cost Categories Structured & Communicated Job Descriptions Hiring / Internal Assignment Standards Qualification Program vs. Read-and- Understand / Training-for-Compliance Team-based Knowledge Sharing / CI Routine Pre-deviation Improvement Program Individual Performance Discussion Routine Supervisor / Manager Business & Leadership Skill Development Range: $240,000 $710,000 total

29 Who has time or money to spend setting ideal work conditions? Turnover Cost Categories Hiring & Onboarding Loss of Skill / Efficiency / Productivity Short-fused Backfill & Training Loss of Knowledge / Experience Bank Workforce Morale Impact Range: $35,000 - $170,000 per loss Control Cost Categories Structured & Communicated Job Descriptions Hiring / Internal Assignment Standards Qualification Program vs. Read-and- Understand / Training-for-Compliance Team-based Knowledge Sharing / CI Routine Pre-deviation Improvement Program Individual Performance Discussion Routine Supervisor / Manager Business & Leadership Skill Development Range: $240,000 $710,000 total

30 Behavioral Spectrum - CAPA Carelessness Misguided Decision Poor Judgment Malfeasance Distracted Unqualified Uncertain Unqualified Pressured Apathetic Pressured Greedy Malicious Qualify, Reinforce Standards Qualify & Support Re-focus Priorities Fix the Culture

31 How to Spot Trouble in Your Work Culture Assess your company s tendencies toward: Prioritizing production / speed over all else Prioritizing cost control over all else Uncertainty / disagreement over priorities General lack of accountability for compliance with procedures Complacency or tolerance of unresolved issues Lack of support for those who want to resolve issues Culture of fear or blame inhibits speaking up about concerns Hiring to fill roles / poor screening Lack of role qualification using only read-and-understand Senior leaders that shift blame to operators & techs

32 When culture needs to be addressed Take a workplace pulse Survey & interviews Remove your biases De-pressurize the culture Relieve the pressure Company-wide discussion forums Reinforce with team discussions Re-focus on excellence Collaborate on solutions Shift from the negative message to the positive message

33 Sequence of Improvement Steps Market Direction & Leadership Alignment Process Flows & Critical Tasks Talent Plan & Job Roles Systems, SOP Improvements Qualification, Development, Training KPIs, KM, Continuous Improvement 33

34 Conditions for Predictable Human Performance Collaborative & respectful work environment Constructive supervisors Well-written procedures & job aids Productive People Clear expectations & priorities Effective training Skill qualification