A Focus on the Incoming Quality Control Department of a Medical Device Manufacturer

1.0 Research Context: Aims and Objectives The world is changing at an increasingly fast pace, and, of course, the quality field must adapt to fit its shifting landscape (Cudney and Keim, 2017:5). The concept of quality has... [ view full abstract ]

1.0 Research Context: Aims and Objectives

The world is changing at an increasingly fast pace, and, of course, the quality field must adapt to fit its shifting landscape (Cudney and Keim, 2017:5).

The concept of quality has evolved over time and this change has found its reflection in the standards and regulations in the manufacturing and medical devices sector.  Additionally, satisfying customers’ needs is now the focus of the industry experts in the regulatory requirements for medical devices providers. This research examines one department in one medical device provider in the light of the ‘quality concept’, and within the parameters of regulatory requirements in the sector.  

This study provides an extensive review of the quality movement, and how it evolved to business concepts such as Total Quality Management and Quality Management System.  The two domains, the foundations of quality concept and the regulatory standards for medical devices, are the basis for developing assessment criteria that this researcher employs to examine the Incoming Quality Control (IQC) department in a medical devices manufacturer.

2.0 Design, Methodology, Approach

This researcher examined the concept of quality and how it pertains to one department in one company.  Thus, a qualitative case study approach was selected for this research as it allows an investigation to retain the holistic and meaningful characteristics of real-life events – such as individual life cycles, organisational and managerial processes (Yin, 1989:14).  The semi structured inquiry strategy was applied following one interview guide during all interviews.  In many instances, the respondents were deviating from the questions and the issues of immediacy dominated the conversation.  This pattern determined the method of analysing the enquiry data findings where a three-stage analysis process was employed that consists of open coding, axial coding and selective coding (Corbin and Strauss, 1990).

In the early stages of this research an open coding approach was applied for the analytical breakdown of the empirical data, where codes were assigned to the two master interview transcripts, in total 379 codes were identified across the two interviews.  The uncovered themes and subthemes from the two master interviews were further cross referenced with the remaining transcripts for the frequency of occurrence.

3.0 Findings

This research’s experimental findings were subject to an open, and axial coding, where out of a total of 379 codes, this study revealed 23 themes and 118 sub-themes, of which 10 main data points from each category and sub-category were thoroughly evaluated: 

 10 Key Themes as follows:

•Theme 1.0 Quality is 'Right the First Time'

•Theme 2.0 Quality in Central

•Theme 3.0 IQC Department Impact on the Organisation

•Theme 4.0 On-the-Job Training Delivery

•Theme 5.0 Progression Training

•Theme 6.0 Personal Development in IQC

•Theme 7.0 IQC Training and Audit Readiness

•Theme 8.0 MyLearning in IQC

•Theme 9.0 Identification of Non-Conformances in IQC Department

•Theme 10.0 Support Staff Involvement in Training Delivery

This research uncovered that elements of the quality gurus’ definition are present in the IQC Inspectors understanding of quality such as ‘Right the First Time’ and ‘Meeting Standards’. However, the patient focus, the product safety, and effectiveness have been found to be missing. While a new finding has been discovered where the primary results identified ‘Quality of People’ as a component of the quality definition that has not been reflected in the secondary data, and in the regulatory terms. The centric position of quality in the company has been acknowledged by these study participants, though an observation that the productivity can hinder the pursuit of quality has been revealed.  This researcher provided a recommendation for this finding to educate the personnel to eliminate this misconception.

A strong dynamic between the IQC function and production lines has emerged from these research enquiry findings.  The internal and external customer’s approach is recognised in the quality settings, and the management team in addressing these findings should work on the inter-departmental problems rather than seek issues within the IQC function.

The assessment of On-the-Job training uncovered areas for improvement pertaining to the IQC Inspectors training such as lack of standardisation, insufficient resources for the skills and competency development of personnel that can hinder the success of the Quality System objectives.

This researcher developed a model for practice that consists of six elements that are considered to be fundamental for the IQC Inspectors to understand the company Management System and, as a result, the fundamentals of quality so important in the medical devices industry.  

The management team, considered to be Line Support Team in the context of this study, has been found not to fully understand the importance of their involvement in the IQC department training, and it has been recommended as an area for improvement for the effectiveness of the Inspectors training.  This study assessment of the IQC department training has uncovered inconsistent findings regarding its effectiveness.  Considering that six out of ten measures have failed the test, the training intervention has not been found fit for purpose.

4.0 Practical Implications

This researcher has developed a model for practice for the IQC department training, and the suggested model addresses the areas for improvement. Moreover, the new model illustrates the interrelations between the IQC department and the company, and demonstrates the foundation for the training delivery best practice.  This research suggests a centric position of the IQC Inspector, and identifies five fundamentals considered to be important elements of the quality concept, and the company Quality Management System.  The model illustrates a continuous and an ongoing interaction between the person at the centre and people, processes, and systems.  

5.0 Social implications

The evaluation measures uncovered issues that pertain to the training delivery of the studied function, while at the same time it identified best practices that should continue to be employed. This researcher recommends greater emphasis on the quality components such as delivering an effective and safe product to the customer; meeting standards to fulfil the changing needs of the patient; greater awareness that people are an important element of the quality concept. Additionally, the approach that quality is ‘Right the First Time’ as strongly demonstrated by this study’s enquiry findings, should continue to be accentuated. 

The internal and external customers approach to quality has been uncovered in the enquiry findings and identified a strong dynamic between the Operations and the IQC Department.  In order to improve this challenging interaction between the IQC function and production lines, the management team should shift their focus from seeking the departmental and functional faults, to identifying inter-departmental problems.

Finally, the Line Support Team members need to gain a full understanding of their role in the IQC department training delivery. While they are not involved in the actual On-the-Job training, they need to ensure that the Inspectors are equipped with the necessary tools, have the resources to develop competencies, and confidence in the quality control of the incoming materials.

6.0 Originality and Value

This study developed an assessment criterion for training intervention in the context of quality and regulatory standards.  This measuring tool is transferable and could be utilised for examination of other training interventions in medical devices and, additionally, in pharmaceutical sectors considering that the regulatory element of the assessment is amended accordingly with the specific industry requirements. 

This research uncovered that elements of the quality gurus’ definition are present in the IQC Inspectors understanding of quality such as ‘Right the First Time’ and ‘Meeting Standards’. However, the patient focus, the product safety, and effectiveness have been found to be missing. This study proposes that a new finding has been discovered.  The primary results identified ‘Quality of People’ as a component of the quality definition that has not been reflected previously in the secondary data, and in the regulatory terms.

References

Corbin, J., Strauss, A. (1990) “Grounded Theory Research: Procedures, Canons, and Evaluative Criteria”, Qualitative Sociology, Vol. 13, Issue 1, p. 7, 8, available at http://med-fom-familymed-research.sites.olt.ubc.ca/files/2012/03/W10-Corbin-and-Strauss-grounded-theory.pdf, accessed at 4 p.m, 13/5/17. 

Cudney, E. A. and Keim, E. M. (2017) “The Changing Role of Quality in the Future”, Journal for Quality & Participation, Vol. 39, Issue 4, pp. 4-11, available at http://search.ebscohost.com/login.aspx?direct=true&db=bch&AN=121007172&site=ehost-live&scope=site, accessed at 9 p.m., 20/2/17.

Yin, R. K. (1989) Case Study Research: Design and Methods, London: Sage Publications, pp. 14, 29-31.