In the Pharmaceutical GMP Industry, If Quality is Everyone's Responsibility, Is It No One's Responsibility?
The phrase "Quality is everyone's responsibility" is often misinterpreted in the Pharmaceutical Inspection Co-operation Scheme - Good Manufacturing Practices (PIC/S GMP) pharmaceutical industry, leading to the belief that quality oversight is solely the responsibility of the Quality Assurance (QA) department. This article explores the critical role of QA professionals in fostering a collaborative quality culture, asserting that quality should be integral to every employee's responsibility. It emphasizes management commitment in establishing effective Pharmaceutical Quality System (PQS) and encourages viewing QA as partners. By engaging teams across various functions, organizations can cultivate a unified commitment to quality and implement strategies for overcoming resistance and measuring success through quantifiable metrics.
Introduction
In the highly regulated pharmaceutical GMP industry, the phrase "Quality is everyone's responsibility" is frequently cited yet often misinterpreted. This misinterpretation can lead to a scenario where quality is perceived as the sole responsibility of the QA department, resulting in a culture where quality oversight is neglected. Many employees may feel disconnected from quality initiatives, believing that their roles do not directly impact overall quality. This article aims to address these misconceptions and highlight the essential role of QA professionals in fostering a culture of quality across all organizational levels. It underscores the need for management to embrace their responsibilities in promoting quality and for all employees to recognize their contributions to ensuring product integrity and patient safety. By shifting the focus from viewing quality as an isolated function to an integral part of every role, organizations can enhance their commitment to excellence and continuous improvement.
Edwards Deming famously stated, "Quality is everyone's responsibility."1 While this sentiment is valid, it can easily be misinterpreted. If Deming's quote is considered in isolation, it risks falling into the familiar "everybody, somebody, nobody" trap, where individuals assume that someone else is accountable for quality. This leads to complacency and oversight. It is important to recognize that most employees do not come to work intending to perform poorly, undermine the organization, or resist improvement. When lapses occur, it is often because individuals are either unaware of their responsibilities or lack clarity regarding how to contribute effectively.
To emphasize the significance of quality across the organization, we must frame it as integral to every role and function, rather than solely the responsibility of the QA department. Achieving this requires a concerted effort to communicate that quality influences every facet of the organization, from manufacturing to marketing, and that each employee plays a vital role in ensuring product integrity and patient safety.
Recommendation
10/11 February 2026
Handling of Foreign Particles in APIs and Excipients - Live Online Training
What's the basis for the concern?
Management responsibilities have been a topic with regulatory agencies for quite some time, as evidenced by the various regulations and guidance we work within. For example:
PIC/S GMP defines:
- 1. Senior management has the ultimate responsibility to ensure an effective PQS is in place, adequately resourced, and that roles, responsibilities, and authorities are defined, communicated, and implemented throughout the organization. Senior management's leadership and active participation in the Pharmaceutical Quality System is essential. (PIC/S GMP PE 009-17 (Part I), Chapter 1, sections 1.5)2
- 2. There should be periodic management review, with the involvement of senior management, of the operation of the Pharmaceutical Quality System to identify opportunities for continual improvement. (PIC/S GMP PE 009-17 (Part I), Chapter 1, sections 1.6)2
- 3. A Quality Manual or equivalent documentation should be established and should contain a description of the quality management system including management responsibilities. (PIC/S GMP PE 009-17 (Part I), Chapter 1, sections 1.7)2
EU (European Union) GMP applies ultimate responsibility for quality and the PQS to senior management and assigns specific responsibilities for product and process quality to the heads of quality and production, along with the head of quality control (Eudralex V4, Chapters 2 and 6).3
ICH (International Council for Harmonization) Q10 defines senior management as having ultimate responsibility for ensuring an effective PQS is in place, emphasizing that management responsibility is integral to a functioning pharmaceutical quality system.4
ISO 9001:2015 specifies:
- 1. Senior management must demonstrate leadership and commitment by communicating the importance of effective quality management and conforming with requirements. (Clause 5.1.1(f))5
- 2. Top management must ensure that the quality policy is communicated, understood, and applied throughout the organization. (Clause 5.2.2(b)5
- 3. Top management must establish objectives and communicate them to relevant functions and levels. (Clause 6.2.1(f)5
- 4. Organizations must determine what, when, and how information is to be communicated within the organization, as to whom and by whom communication is to be delivered. (Clause 7.4)5
Bridging the gap
Given these frameworks, it is evident that QA professionals must bridge the gap between the ideal of 'everyone's responsibility' and the practical implementation of quality in daily operations.
The Importance of Management Responsibilities: The international guidelines underscore that senior management has ultimate responsibility for the effectiveness of the PQS. This leadership is critical in establishing a culture of quality that permeates the organization. When senior management demonstrates commitment to quality by actively participating in quality initiatives, it sets a tone that encourages all employees to prioritize quality in their roles.6
Engaging Teams Effectively: The first step is to shift the perception of QA from enforcers to collaborators and educators. For example, a pharmaceutical company could implement regular cross-departmental workshops where QA staff and operational teams collaborate on quality initiatives. In one such workshop, the QA team helped the Quality Control (QC) group understand how minor adjustments in their materials sampling processes could significantly reduce deviations.
The QA team introduced a randomized sampling strategy instead of a fixed pattern, ensuring samples were representative of the entire batch. They also provided training on purified water sampling techniques, highlighting the proper steps for glove sanitation with alcohol to minimize contamination risks in the water samples. These adjustments improved test reliability and fostered a greater sense of shared responsibility among QC staff, empowering them in their role in maintaining product quality.6
Recommendation
Heidelberg, Germany10/11 February 2026
Combination Products
Empowering Employees: When management communicates the importance of quality, as specified in ISO 9001:2015, it empowers employees to take ownership of their contributions. For instance, after introducing a quality dashboard that displays real-time metrics, employees in the pharmaceutical outer packaging lines began to take pride in their high performance. This dashboard provided immediate feedback on key quality indicators, such as defect rates, adherence to specifications, and production efficiency.
The availability of real-time metrics allowed employees to monitor their performance continuously, fostering a sense of accountability and encouraging proactive problem-solving. For example, if an increase in defect rates was detected, employees could quickly identify the issue and implement corrective actions before it escalated into a larger problem. This initiative not only led to a 20% reduction in errors over six months but also promoted a culture of continuous improvement. In another example, a team that regularly reviewed and discussed performance metrics related to quality was able to identify specific areas for improvement. By aligning departmental objectives with the organization's quality goals, they created a shared commitment to quality that enhanced overall productivity and morale. The collaborative environment encouraged employees to contribute suggestions based on real-time data, further reinforcing their engagement and investment in maintaining high-quality standards.7
Ongoing Leadership Involvement: Periodic management reviews, as outlined in PIC/S GMP and EU GMP, should focus on compliance and identifying opportunities for continuous improvement. A generic drug manufacturing company, for example, established a regular review process that enabled quick identification of noncompliance trends, leading to proactive measures that improved overall quality.8
The regular review process includes several key items:
- Performance Metrics: Assessing indicators like deviation rates, CAPA (Corrective and Preventive Action) statistics, and change control provides insights into quality performance and areas needing attention.
- Product Complaint Handling: Reviewing product complaints helps identify recurring issues and informs necessary corrective actions.
- Audit Findings: Analysing internal and external audit results helps identify systemic issues and evaluate the effectiveness of corrective actions.
- Risk Assessments: Evaluating potential risks allows management to prioritize areas for improvement and mitigate future issues.
- Training and Development: Reviewing training effectiveness ensures employees are equipped to meet quality standards and regulatory requirements.
- Action Plans and Effectiveness Checks: Tracking progress on action plans ensures accountability and follow-through on identified issues.
By emphasizing the importance of management responsibilities in fostering a culture of quality, we can bridge the gap between theoretical frameworks and practical application.9 In doing so, we create an environment where quality is truly everyone's responsibility, supported by strong leadership and effective collaboration.
We cannot march around with the same script everywhere. We must tailor our communication to resonate with different teams and individuals. Here's how we can do this effectively:
- Production Team: When working with the Production team, QA can actively participate in process reviews and workshops, including Gemba walks to observe processes firsthand. This involvement allows QA to identify potential sources of variation and implement robust controls to minimize risks to product quality. Additionally, QA can conduct CAPA effectiveness checks and occupational safety and health assessments. Performance metrics such as yield rates, defect rates, and adherence to SOPs can be monitored to evaluate the effectiveness of quality initiatives and drive continuous improvement.10
- Engineering Team: In collaboration with the engineering team, QA can provide critical input during the design and validation of equipment. This ensures that equipment not only meets GMP requirements but also performs as intended throughout its lifecycle. QA should also ensure adherence to annual preventive maintenance checks and the validity of equipment qualifications. Key performance indicators (KPIs) such as equipment downtime, validation success rates, and compliance with design specifications can help track the effectiveness of engineering solutions in supporting quality objectives.
- Supply Chain Team: When partnering with the supply chain team, QA plays a vital role in ensuring that suppliers are qualified and that materials meet established quality standards. This collaboration includes conducting supplier audits, evaluating supplier performance, and establishing criteria for material acceptance. Metrics such as supplier defect rates, on-time delivery rates, and compliance with material specifications can be utilized to assess supplier performance and strengthen the overall quality of the supply chain.11
- Quality Control Team: QA should maintain a strong partnership with the quality control (QC) team to ensure that testing protocols align with both regulatory requirements and organizational standards. This includes conducting regular surveillance checks for computer system validation (CSV), data integrity, and security. Additionally, QA should review out-ofspecification (OOS) and out-of-trend (OOT) results, handling investigations effectively. Performance metrics such as test accuracy, turnaround time for results, and the rate of nonconformance can track the QC team's effectiveness in maintaining product quality.12
- Procurement Team: In collaboration with the procurement team, QA can help define quality specifications for materials and services. This collaboration ensures that all purchased items meet the organization's quality standards before they reach production. Key activities include supplier and vendor qualification, as well as tracking supplier performance metrics such as on-time delivery and quality compliance.13 By providing training and resources on quality requirements, QA can empower procurement professionals to make informed decisions. Metrics such as the percentage of compliant materials received, and the rate of supplier-related quality issues can measure procurement's contribution to quality objectives.
This approach enhances collaboration and fosters a unified commitment to quality across all departments, driving continuous improvement and compliance throughout the organization.14 By regularly monitoring and analysing performance metrics, each team can identify areas for enhancement and collaboratively pursue shared quality objectives.
Rather than enforcing compliance in a way that breeds resistance, we should emphasize how specific quality practices prevent errors, save time, improve profitability, and enhance patient safety. It is crucial to communicate the rationale behind quality initiatives, rather than merely issuing directives regarding Incident Reports or CAPA plans. Making quality personal is essential. We must illustrate how quality affects not only the final product but also individual roles and job satisfaction. This transforms the abstract notion of 'everyone's responsibility' into concrete actions and attitudes.
Fostering a Quality Culture
A quality culture in the pharmaceutical industry refers to the collective mindset, values, attitudes, and behaviours within an organization that prioritize and promote a commitment to quality.15 Here are key elements that contribute to fostering a strong quality culture, along with actionable strategies for implementation:
The Shift from Policing to Support
Historically, QA has often been perceived as a policing function, focused primarily on compliance and enforcement. This perspective can create a disconnect between QA and other departments, leading to resistance and a lack of engagement. To transition from this policing mindset to one of support, QA must position itself as a collaborators and educators in achieving quality objectives rather than merely a regulatory overseer.
Leadership Commitment:
How: Conduct regular quality town halls where leadership shares quality goals, success stories, and challenges. This creates transparency and openness.
Tip: Encourage leaders to participate in frontline activities, such as quality audits or Gemba walks, to demonstrate their commitment and gather firsthand insights, reinforcing that QA is there to support rather than just enforce.
Employee Engagement:
How: Implement a quality champions program, where selected employees from various departments advocate for quality initiatives and serve as liaisons between their teams and QA.
Tip: Create a recognition system, such as a "Quality Star" award, that acknowledges employees who contribute innovative ideas or excel in quality practices, making QA a source of empowerment.
Training and Education:
How: Develop interactive training modules that include roleplaying scenarios related to quality issues specific to employees' tasks, making learning more relatable.
Tip: Organize regular "lunch and learn" sessions where employees can discuss recent quality challenges and solutions, enhancing peer-to-peer learning while positioning QA as a resource.
Clear Quality Objectives:
How: Involve employees in the creation of SMART (Specific, Measurable, Achievable, Realistic, Time-bound) objectives during team meetings, ensuring that everyone understands their contributions to quality improvement.
Tip: Utilize visual management tools, such as dashboards or scorecards displayed in common areas, to track progress on these objectives and celebrate milestones.
Documentation and Standard Operating Procedures (SOPs):
How: Regularly review and update SOPs with input from employees who execute the processes, ensuring they are practical and user-friendly.
Tip: Simplify documentation with flowcharts and checklists that outline critical steps, helping employees adhere to processes while seeing QA as an ally in achieving clarity.
Risk-Based Thinking:
How: Conduct risk assessment workshops where teams can collaboratively brainstorm potential risks in their processes and develop mitigation plans.
Tip: Create a risk register that allows employees to log risks and proposed solutions, fostering a culture of proactive risk management with QA guiding the process rather than policing it.
Continuous Improvement:
How: Establish a quality suggestion box, both physical and digital, where employees can submit ideas for process enhancements. Ensure there is a structured process for evaluating and implementing these suggestions.
Tip: Celebrate and share success stories resulting from continuous improvement initiatives through newsletters or team meetings, reinforcing the value of employee contributions and QA's supportive role.
Collaboration and Communication:
How: Create cross-functional teams tasked with specific quality improvement projects, ensuring diverse input and perspectives on quality challenges.
Tip: Use collaborative platforms, such as shared drives or project management tools, to facilitate the sharing of best practices, lessons learned, and updates on ongoing initiatives, fostering a unified commitment to quality.
Audits and Inspections:
How: Train employees on what to expect during audits and involve them in preparation activities to demystify the process and reduce anxiety.
Tip: Conduct mock inspections as learning opportunities, allowing teams to practice and identify gaps in compliance and processes, reinforcing best practices while showing QA's role as a mentor.
Customer Focus:
How: Regularly gather and analyze customer feedback through surveys, focus groups, or direct interviews to identify areas for quality enhancement.
Tip: Share customer testimonials and feedback during team meetings to illustrate the real-world impact of their work on customer satisfaction, fostering a sense of purpose and reinforcing QA's supportive role.
Additional Possibilities for Support
To further position QA as a service provider and support function, consider the following strategies:
Mentorship Programs: Assign QA professionals as mentors to employees in other departments, offering guidance on quality-related matters and best practices, fostering a culture of learning and collaboration.
Quality Circles: Form small groups of employees from various departments who meet regularly to discuss quality issues and propose solutions, fostering a culture of collaboration. This encourages ownership and strengthens interdepartmental relationships. Feedback Mechanisms: Create formal channels for departments to provide feedback on QA processes, such as surveys or suggestion boxes. This ensures QA remains responsive to the needs of other teams.
Resource Development: Develop quality toolkits or resources that employees can use independently to address quality issues, reinforcing QA's role as a helpful partner.
Team-Building Activities: Organize joint team-building events between QA and other departments to strengthen relationships and promote collaboration around quality initiatives.
By implementing these strategies, QA can shift from a regulatory role to a supportive partner, enhancing the overall quality culture within the organization.
Measuring Success
To gauge the effectiveness of our shift towards a more collaborative approach to quality, we need to establish clear, quantifiable metrics that can provide insights into our progress and impact. Here are some key areas to focus on:
- Reduction in Deviations and CAPAs: Tracking the number of deviations and Corrective and Preventive Actions (CAPAs) over time can indicate the effectiveness of our quality management practices.16 A significant reduction suggests that proactive measures are being successfully implemented, and that teams are adhering to established protocols. Regularly reviewing these metrics in team meetings can reinforce accountability and highlight areas for ongoing improvement.17
- Improved Process Capability: By measuring process capability indices (like Cp and Cpk), we can assess how well our processes meet specifications.(18) An increase in these indices indicates that processes are becoming more stable and capable, leading to higher quality outputs. This can be complemented by Six Sigma methodologies to set targets for improvement and track progress.19
- Increased Employee Engagement in Quality Initiatives: Employee engagement is crucial for fostering a quality culture. We can measure engagement through surveys, participation rates in quality training sessions, and involvement in quality improvement projects. High engagement levels often correlate with improved morale and a greater commitment to quality objectives. Celebrating employee contributions to quality initiatives can further enhance this engagement.20
- Positive Feedback from Other Departments: Gathering feedback from various departments regarding QA's collaborative approach can provide valuable qualitative insights. Surveys or informal feedback sessions can be used to assess perceptions of QA's support and involvement. Positive feedback indicates that QA is effectively partnering with other teams and contributing to a shared quality vision.
- Performance Metrics Specific to Each Team: As previously outlined, each department should have specific performance metrics related to quality that can be monitored. This includes metrics like supplier performance in procurement, equipment downtime in engineering, and test accuracy in quality control. Regularly reviewing these metrics can drive accountability and continuous improvement within each team.21
- Timeliness of Issue Resolution: Tracking how quickly issues are identified and resolved can provide insights into the effectiveness of our collaborative efforts.22 A decrease in resolution times for CAPAs and other quality-related issues indicates that teams are working effectively together to address problems.23
- Training and Development Outcomes: Measuring the effectiveness of training programs related to quality can help ensure that all employees are equipped with the necessary knowledge and skills.24 Pre- and post-training assessments can provide insights into knowledge gains, while tracking the application of training in day-to-day operations can highlight its practical impact.25
Real-World Example: Measuring Success
A pharmaceutical company that implemented employee engagement surveys found that departments with higher engagement scores reported fewer deviations. After introducing a comprehensive quality training program initiated by the QA team-acting as both educators and collaborators-one department experienced a 30% decrease in errors within three months. The initiative included workshops, hands-on sessions, and interactive e-learning, emphasizing key quality principles such as GMP, risk management, and documentation standards. QA facilitated case studies and roleplaying exercises, enhancing employees' understanding of how their work impacts product quality. This direct engagement demonstrated a strong correlation between employee engagement, quality training, and improved quality outcomes.26
Overcoming resistance
Individuals or teams may initially resist this shift in approach, often due to concerns about changes to established processes or fears about increased scrutiny.27 To overcome this resistance, we can take several proactive steps:
Demonstrate Value Through Small Wins: Highlighting small successes can build momentum for broader change. For example, if a collaborative project leads to reduced cycle times or improved quality metrics, sharing these successes with the organization can illustrate the tangible benefits of collaboration.28
Engage Stakeholders Early: Engaging stakeholders early in the process is crucial for alleviating concerns and fostering buy-in.29 By soliciting input and feedback during the planning stages, organizations can ensure that initiatives effectively address specific team needs and concerns. This collaborative approach not only enhances commitment but also leads to more successful and relevant outcomes.30
Communicate Openly and Frequently: Communicating openly and frequently about the goals of quality initiatives is essential for fostering engagement and collaboration.31 Regular updates and success stories help keep everyone informed, reinforcing the benefits of teamwork. This transparency builds trust and motivates employees to actively participate in quality improvement efforts, driving overall success.32
Provide Support and Resources: Offering training and necessary tools can ease the transition and empower teams to collaborate effectively. By equipping employees with the right resources and frameworks, organizations foster a smoother integration of changes, enhancing overall productivity and quality outcomes.33
Celebrate Collaborative Efforts: Recognizing and rewarding teams and individuals who embrace collaborative quality practices is essential for reinforcing desired behaviours.34 This recognition fosters a culture of quality throughout the organization, motivating others to adopt similar practices. By celebrating successes, organizations encourage ongoing commitment to quality improvement and collaboration, driving overall performance.35
Hypothetical Scenario: Overcoming Resistance
Consider a scenario where a pharmaceutical company faced resistance to a revised quality control procedure. To address this, management involved employees in the development process, with QA acting as educators and collaborators. QA facilitated hands-on training sessions that clarified the new procedures and their relevance to daily tasks. Employees were encouraged to voice their concerns and suggestions during pilot implementations.
As a result, the revised procedure improved documentation accuracy and workflow efficiency, enhancing compliance with regulatory standards. This collaborative approach fostered a sense of ownership among employees, ensuring a smoother transition to the new practices.36
Final thoughts
Reflecting on the preceding discussion, consider the following question that often arises among pharmaceutical professionals:
Who is ultimately responsible for quality and the pharmaceutical quality system?
The options are:
- Option A: All personnel in the company
- Option B: Quality Assurance Department
- Option C: Senior Management within the organization
This question prompts an examination of shared responsibility for quality within the organization. Acknowledging that quality is a collective effort is vital for fostering commitment to quality practices at all levels.37 Our goal is to translate "quality is everyone's responsibility" into actionable terms. Senior management and organizational leaders play a crucial role in positioning Quality Assurance professionals and quality leadership as collaborators and educators. By doing so, they can engage teams across the organization and demonstrate the value of quality through measurable outcomes.37 Ultimately, we must cultivate a culture where quality is a fundamental value integrated into all aspects of our pharmaceutical operations, ensuring it becomes a shared responsibility embraced by every employee.38
Conclusion
The commitment to quality in the pharmaceutical GMP industry must be embraced as a collective responsibility rather than a task relegated to the QA department. This article emphasizes that quality is not merely a program or project but a fundamental value that should permeate every aspect of organizational operations. By fostering a culture where all employees understand their role in quality, supported by strong leadership and clear communication, organizations can achieve meaningful and sustainable improvements. To bridge the gap between the ideal of "everyone's responsibility" and practical implementation, senior management must actively engage with teams, empower employees, and establish clear quality objectives. It is crucial to recognize that the notion of "it is no one's responsibility" is erroneous; this "everybody, somebody, nobody" trap leads individuals to assume that someone else is accountable for quality. Moreover, measuring success through quantifiable metrics will help track progress and reinforce accountability. Ultimately, cultivating a shared commitment to quality is essential for ensuring product integrity, enhancing patient safety, and achieving excellence in the pharmaceutical industry.
About the Author
Markus LUNG Chi-ho, BPharm BPharm(ChinMed) MBA, is a registered pharmacist and qualified person in Hong Kong. Markus brings over 27 years of experience in the health and pharmaceutical industry. His extensive expertise contributes to advancing quality standards and operational excellence in the sector.
Note:
1 Pharmaceutical Inspection Co-operation Scheme (PIC/S). Guidance on Good Manufacturing Practices. PE 009-17 (Part I), Chapter 1, sections 1.5-1.7; 2017.
2 European Commission. The Rules Governing Medicinal Products in the European Union. Eudralex V4, Chapters 2 and 6; 2014.
3 International Council for Harmonisation (ICH). Q10 Pharmaceutical Quality System; 2008.
4 International Organization for Standardization (ISO). Quality Management Systems-Requirements. ISO 9001:2015; 2015.
5 Institute for Healthcare Improvement. Quality Is Everyone's Responsibility [Internet]. 2016. Available from: https://www.ihi.org/insights/quality-everyones-responsibility
6 Pimentel L, Major M. Key success factors for quality management implementation: Evidence from the public sector. Total Quality Management & Business Excellence. 2015;27:1-16. doi: 10.1080/14783363.2015.1055239.
7 Stanojeska M, Minovski R, Jovanoski B. Top management role in improving the state of QMS under the influence of employee's involvement: best practice from the food processing industry. Journal of Industrial Engineering and Management. 2020;13:93. doi: 10.3926/jiem.3031.
8 Boguslavsky V, Gutierrez R, Holschneider S. Effective leadership for quality improvement in health care: a practical guide. Chevy Chase, MD: University Research Co., LLC (URC); 2019.
9 Wangwacharakul P. From perception to practice: quality management in multinational company from a Swedish perspective. International Journal of Lean Six Sigma. 2024;15(6):1265-89. doi: 10.1108/IJLSS-12-2023-0230.
10 Tambare P, Meshram C, Lee C-C, Ramteke R, Imoize A. Performance measurement system and quality management in data-driven Industry 4.0: a review. Sensors. 2021;22(1):24. doi: 10.3390/ s22010224.
11 Mani A, Kalam A, Jeganathan K. Analysis of performance measurement and metrics of supply chain management: a conceptual framework. Animal Health Research Reviews. 2023;4:1100-9.
12 Klyatis LM, Klyatis EL. Practical accelerated quality development and improvement in manufacturing and design. In: Klyatis LM, Klyatis EL, editors. Accelerated quality and reliability solutions. Elsevier Science; 2006. p. 363-411. doi: 10.1016/B978-008044924-1/50005-8.
13 Chivu C, Paunoiu V, Gabriel R, Afteni M. Evaluation, monitoring and auditing of suppliers in supply chain management. International Journal of Manufacturing Economics and Management. 2021;1:6. doi: 10.54684/ijmem.2021.1.2.6.
14 Meryem M, Abdelghani B. The reality and limits of quality culture. The Journal of Contemporary Issues in Business and Government. 2023;29(4):142-7.
15 Tadesse Bogale A, Debela KL. Organizational culture: a systematic review. Cogent Business & Management. 2024;11(1). doi: 10.1080/23311975.2024.2340129.
16 Riwayadi E. The Leadership Importance in International Organization for Standardization (ISO) Implementation: A Literature Review. FJSR [Internet]. 2024 Jan. 25 [cited 2025 May 18];3(1):125-44. Available from: https://journal.formosapublisher.org/index.php/fjsr/article/view/7730
17 Afridah, Lubis M. The Role of Communication and Employee Engagement in Promoting Inclusion in the Workplace: A Case Study in the Creative Industry. Feedback International Journal of Communication. 2024;1:1-15. doi: 10.62569/fijc.v1i1.8.
18 Deshpande R. How does Quality Culture contribute to Compliance? | Scilife [Internet]. Scilife. 2024. Available from: https://www.scilife.io/blog/quality-culture-compliance
19 Setting and applying SMART objectives | CQI | IRCA [Internet]. Available from: https://www.quality.org/knowledge/applying-smart-objectives
20 The critical role of standard Operating procedures (SOPs) in the pharmaceutical industry [Internet]. 2024. Available from: https://speach.me/blog/the-critical-role-of-standard-operating-procedures-sops-in-the-pharmaceutical-industry
21 Radu C. Fostering a positive workplace culture: Impacts on performance and agility. In: IntechOpen eBooks [Internet]. 2023. Available from: https://doi.org/10.5772/intechopen.1003259
22 Zhang W, Zeng X, Liang H, Xue Y, Cao X. Understanding how organizational culture affects innovation Performance: A Management Context Perspective. Sustainability [Internet]. 2023 Apr 14;15(8):6644. Available from: https://doi.org/10.3390/su15086644
23 Yang Y, Yang B, Onofrei G, Nguyen H, Hlaciuc E. The role of employees in continuous improvement: a study on employee participation. European Journal of Training and Development [Internet]. 2024 Jul 23; Available from: https://doi.org/10.1108/ejtd-10-2023-0167
24 Musheke MM, Phiri J. The effects of effective communication on organizational performance based on the systems Theory. Open Journal of Business and Management [Internet]. 2021 Jan 1;09(02):659-71. Available from: https://doi.org/10.4236/ojbm.2021.92034
25 Hut-Mossel L, Ahaus K, Welker G, Gans R. Understanding how and why audits work in improving the quality of hospital care: A systematic realist review. PLoS ONE [Internet]. 2021 Mar 31;16(3):e0248677. Available from: https://doi.org/10.1371/journal.pone.0248677
26 Okeke NNI, Alabi NOA, Igwe NAN, Ofodile NOC, Ewim NCPM. Customer-Centric quality management: A framework for organizational excellence in SMEs. International Journal of Management & Entrepreneurship Research [Internet]. 2024 Oct 23;6(10):3517-40. Available from: https://doi.org/10.51594/ijmer.v6i10.1659
27 Moradi E. Measuring the impact of CAPA in GMP [Internet]. Pharmuni. 2025. Available from: https://pharmuni.com/2024/11/17/measuring-the-impact-of-capa-in-gmp/
28 WHO guidelines on good manufacturing practices for blood establishments, Annex 4; World Health Organization.WHO Technical Report Series, No. 961, 2011. Available from: https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/production/trs961-annex4-gmp-blood-establishments.pdf
29 Kiran. Process capability. In: Elsevier eBooks [Internet]. 2016. p. 255-9. Available from: https://doi.org/10.1016/b978-0-12-811035-5.00018-0
30 Senvar O, Toz H. Process capability and six Sigma methodology including fuzzy and lean approaches. In: Sciyo eBooks [Internet]. 2010. Available from: https://doi.org/10.5772/10389
31 Jo H, Shin D. The impact of recognition, fairness, and leadership on employee outcomes: A large-scale multi-group analysis. PLoS ONE [Internet]. 2025 Jan 9;20(1):e0312951. Available from: https://doi.org/10.1371/journal.pone.0312951
32 Andersen G. Continuous feedback and improvement - Enhancing QA engineering in higher education [Internet]. MoldStud - Custom Software Development Company. 2024. Available from: https://moldstud.com/articles/p-continuous-feedback-and-improvement-as-a-qa-engineer-in-higher-ed
33 Faozen F, Riza Octavy Sandy S. Performance Management: A new approach in performance management [Internet]. Human Resource Management - An Update. IntechOpen; 2024. Available from: http://dx.doi.org/10.5772/intechopen.1002501
34 Du W, Mo R, Li S, Li B. Research on Collaborative Product Design issue tracking Management model. Physics Procedia [Internet]. 2012 Jan 1;25:666-71. Available from: https://doi.org/10.1016/j.phpro.2012.03.141
35 Nour, Reham Osama. Good Capa Practice - A Six Sigma Approach To Reduce Cost Of Non-Compliance. 2018. Open Access Theses. 1431. https://docs.lib.purdue.edu/open_access_theses/1431
36 Urbancová H, Vrabcová P, Hudáková M, Petr? GJ. Effective training evaluation: the role of factors influencing the evaluation of effectiveness of employee training and development. Sustainability. 2021;13(5):2721. doi: 10.3390/su13052721.
37 Walters K, Rodriguez J. The importance of training and development in employee performance and evaluation. World Wide J Multidiscip Res Dev. 2017;3:206-12.
38 Damawan AH, Azizah S. Resistance to Change: Causes and Strategies as an Organizational challenge. Proceedings of the 4th ASEAN Conference on Psychology, Counselling, and Humanities (ACPCH 2018) [Internet]. 2020 Jan 1; Available from: https://doi.org/10.2991/assehr.k.200120.010
