A critical evaluation and measurement of organisational readiness and adoption for continuous improvement within a medical device manufacturer

Figures & data

Table 1.. Critical success factors and critical failure factors.

Critical success factors
1. Uncompromising top management support and commitment; 2. Effective communication at all levels vertically and horizontally; 3. Strategic and visionary leadership; 4. Developing Organisational readiness; 5. Resources and skills to facilitate implementation; 6. Project selection and prioritisation; and 7. Organisational culture	Antony et al., (2012) McDermott et al. (2022)
1. Setting a clear vision for establishing the desired culture; 2. Commitment of both financial and personnel resources for the initiative; 3. A clear strategic deployment plan showing the tangible objectives and goals of the initiative; 4. Development of a communication plan (i.e. need for the initiative, the benefits of implementation, roles and responsibilities of everyone in the new way of thinking, etc.); 5. Clear direction and guidance on deploying Six Sigma; and reward and recognition system, etc. 6. Communication the vision to all employees at various levels to gain organisational commitment; and 7. Empowering employees and giving them a sense of ownership.	Antony and Snee (2010) Brown et al. (2008), Iyede, Fallon, and Donnellan (2018)
Critical Failure Factors
(1) Lack of top management attitude, commitment, and involvement	Albliwi et al. (2014),) Antony et al. (2012) McDermott et al. (2022) Trubetskaya,2022 Manto and McDermott (2022).
(2) Lack of training and education
(3) Poor project selection and prioritization
(4) Lack of resources (for example financial, technical, and human)
(5) Weak link between the CI projects and the strategic objectives of the organization
(6) Resistance of culture change
(7) Poor communication
(8) Lack of leadership skills and visionary and supportive leadership
(9) Lack of consideration of the human factors
(10) Lack of awareness of the benefits of LSS
(11) Wrong selection of LSS tools
(12) Narrow view of LSS as a set of tools, techniques and practices
(13) Lack of understanding of the different types of customers/voice of the customer

Table 2. Organisational readiness factors for CI.

Organisational readiness factors for CI
1. Challenge – to what degree are employees involved and committed to their work?	Douglas (2017)
2. Freedom – do employees have autonomy with regards to how they design their work?
3. Idea time – are people given time to think through problems and how they could improve their work and performance?
4. Dynamism – are people positively energised by their work and the work environment?
5. Support – are people supported by management when they put forward new ideas?
6. Openness – is there trust between employees and managers?
7. Playfulness – is the workplace relaxed and people able to laugh and joke with each other?
8. Conflicts – to what degree do people engage in interpersonal conflict?
9. Debates – to what degree are people able to conduct lively debates over contentious issues?
10. Risk taking – is it all right to experiment with new things and fail?
1. Having an improvement strategy, 2. Engagement of staff through appropriate training and development, 3. Having a process view, 4. Understanding customer requirements, 5. Strong committed leadership 6. Understanding demand, capacity and variation	Radnor (2011)
1. Leadership and vision; 2. Management commitment and resources; 3. Linking Lean Six Sigma to University strategy; 4. Customer focus; 5. Selecting the right people.	Antony (2014)

Table 3. The survey questions with the CSF’s being measured under each question.

Survey questions	CSF and readiness factors under focus
The organisation has identified continuous improvement as a priority (Likert scale)	Employee Knowledge
Continuous Improvement is one of our organisations strategic goals (Likert scale)	Links to Strategy
The organisations approach to CI is clear and is communicated to all levels of the business (Likert scale)	Links to Strategy
Which of the following CI programs or approaches are you utilising in your organisation?	Management Communication
Define your awareness of the following CI tools (The 7 Basic Quality tools were listed -each item was given a Likert scale).	Employee Knowledge
CI efforts are rewarded and recognised by management (Likert scale)	Employee Motivation
I regularly suggest improvements to my line manager (Likert scale).	Employee Empowerment
When I suggest improvements my line manager listens and helps me implement them (Likert scale)	Management Communication
When I identify improvement I get the training I need and the time to make the improvements (Likert Scale)	Employee Empowerment
It is not my role to suggest improvements -it is the responsibility of others (Likert scale)	Employee Empowerment
I feel empowered to make small changes and improvements within my role (Likert scale)	Employee Empowerment
CI needs to be more regularly communicated and appear in our plans, strategy and communications (Likert Scale)	Organisational Communication
There need to be more training and information on how I can make improvements (Likert Scale).	Organisational Communication
The objective of the CI program is to (pick 3 of the listed benefits)	Employee Knowledge
The organisation has a CI team/champion. (Likert Scale answers)	Employee Knowledge
Operating in a highly regulated environment can stifle CI (Likert Scale).	Employee Motivation

Figure 1. Number of employees by years of experience.

Figure 2. Respondents by functional area.

Figure 3. Analysis plan.

Table 4. T-test between length of service and responses.

	Length of service	N	Mean	t-Value	p-Value
CI is one of the goals of our overall organisation strategy.	Greater 5 years	49	4.43	0.436	0.66
	Less than 5 years	54	4.35
The organisations approach to continuous improvement is clear and is communicated to all levels throughout the business.	Greater 5 years	49	3.86	0.693	0.49
	Less than 5 years	54	3.7
Continuous Improvement needs to be more regularly communicated and should appear in our strategy, plans and performance.	Greater 5 years	49	4.41	0.124	0.90
	Less than 5 years	54	4.39

Figure 4. The reasons for CI deployment.

Figure 5. Awareness of CI tools and techniques within the organisation.

Figure 6. % Awareness of CI methods by type.

Figure 7. Continuous improvement efforts are rewarded and recognised.

Figure 8. Summary of readiness status.

Antony, J., Krishan, N., Cullen, D., & Kumar, M. (2012). Lean Six Sigma for higher education institutions (HEIs): Challenges, barriers, success factors, tools/techniques. International Journal of Productivity and Performance Management, 61(8), 940–948.

 Google Scholar

McDermott, O., Antony, J., Sony, M., & Healy, T. (2022). Critical failure factors for continuous improvement methodologies in the Irish medtech industry. The TQM Journal, 34(7), 18–38.

 Google Scholar

Antony, J., & Snee, R. (2010). Leading role – Identifying the skills master black belts and black belts need to be effective leaders. Six Sigma Forum Magazine.

 Google Scholar

Brown, A., Eatock, J., Dixon, D., Meenan, B. J., & Anderson, J. (2008). Quality and continuous improvement in medical device manufacturing. The TQM Journal, 20(6), 541–555.

 Google Scholar

Iyede, R., Fallon, E. F., & Donnellan, P. (2018). An exploration of the extent of Lean Six Sigma implementation in the West of Ireland. International Journal of Lean Six Sigma, 9(3), 444–462.

 Web of Science ®Google Scholar

Albliwi, S., Antony, J., Abdul Halim Lim, S., & van der Wiele, T. (2014). Critical failure factors of Lean Six Sigma: A systematic literature review. International Journal of Quality & Reliability Management, 31(9), 1012–1030.

 Google Scholar

Trubetskaya A, Manto D and McDermott O. (2022). A Review of Lean Adoption in the Irish MedTech Industry. Processes, 10(2), 391 10.3390/pr10020391

 Web of Science ®Google Scholar

Douglas, J., Muturi, D., Douglas, A., & Ochieng, J. (2017). The role of organisational climate in readiness for change to Lean Six Sigma. The TQM Journal, 29(5), 666–676.

 Google Scholar

Radnor, Z. (2011). Implementing lean in health care: Making the link between the approach, readiness and sustainability. International Journal of Industrial Engineering and Management, 2, 1–12.

 Google Scholar

Antony, J. (2014). Readiness factors for the Lean Six Sigma journey in the higher education sector. International Journal of Productivity and Performance Management, 63(2), 257–264.

 Google Scholar