Risk Management In field of Quality Management

Risk Management in MEMS and NEMS Manufacturing Facility
[Name of the Writer]
[Name of the Institution]

Research Design and Methodology
Risk assessment in MEMS and NEMS manufacturing environment requires the data to be gathered pertinent to the organization’s structure and production facility. This includes the understanding of internal as well as external risks associated with the organization. Considering the basic risk assessment would require following steps to be included in the risk assessment:
Establishment of the context
Identification of possible risks
Qualitative analysis of risk and its evaluation
Risk Treatment
Monitoring and Review of Associated Risk
Establishment of Context
In this step, the context of the organization is defined that is its business environment. It implies that the term “context” can encompass the very definition of external as well as internal conditions and factors that can have an impact on the organization’s approach (clause 3.01, ISO 9001:2015) based on its products (clause 3.47, ISO 9001:2015), investments, services (clause 3.48, ISO 9001:2015) and most importantly, interested parties (clause 3.02, ISO 9001:2015). Based on the risk assessment framework, the MEMS and NEMS-based industry must have to demonstrate its willingness and capability to facilitate deliverance timely and quality based products that are timely and most importantly, meeting with the regulatory and customer’s requirement having the aim to enhance the customer satisfaction.

Hence, it is of essential importance to developing a context to the study pertaining to internal as well as external perspectives before the designing and implementation phase of quality processes. Hence, it can result in developing an understanding of an organization’s context (clause 4.1, ISO 9001:2015) and subsequently, determine the opportunities and risks associated that are necessary to be addressed (clause 6.1, ISO 9001:2015).
The risk-based thinking for the planning and subsequently, to the quality processes require taking into account the external as well as internal context. The external context can be facilitated by the consideration of different issues arising from technological, competitive, market, legal, social, cultural, and most importantly, economic environments that can be national, international, local and regional. Considering the internal context, it can include the facilitation of the core considerations pertaining to culture, value, performance, and knowledge of the organization.
The context of the organization can include different internal factors including that of organizational culture together with external factors that can be socio-economical perspectives under the umbrella in which the operations takes place. Hence, the requirements for the ISO 9001:2015 are quite generic; however, the way in which the requirements can be implemented differently from one organization to another (Cooper et al., 2014). Risk-based thinking as defined in the ISO 9001:2015 can require assessment of risk qualitatively as well as quantitatively that depends on the degree of formality and rigour that is deemed necessary for the planning and controlling of the ISO 9001: 2015 quality management system together with the activities and component processes (clause 0.5, ISO 9001:2015 quality management system).
Risks Identification
After the establishment of the risk contexts, it is quite essential to identify the risks and subsequently, opportunities that need to be addressed (clause 6.1, ISO 9001:2015) via the ISO 9001: 2015 quality management system and its interlinked processes. Risk identification is the first and most crucial step determination of the potential actions resulting because of the uncertain outcomes that can have the different magnitude of negative impact on the organization’s capability for consistently facilitating the product that needs to be met with applicable statutory, regulatory and customer’s requirements. The risks can also undermine or reduce the customer satisfaction level. Hence, it is quite essential that the risk identification system for the organization would be comprehensive and systematic to ensure that the quality related risks are not ignored by the organization. In this regard, the process inputs can include the historical data, empirical data, theoretical analysis and most importantly, the informed opinion of the experts and project team members. In the study, the structured questionnaire for five professional in the field of quality assurance thereby facilitating informed opinions about the risks associated with the organization as evident in the Appendix A. Consent letters are enlisted in Appendix B. The risks and opportunities are documented in the risks and opportunity (R&O) register.
As per ISO/IEC 31010, a number of techniques for risk identification that could be included in the ISO 9001: 2015 quality management systems. In this regard, the formulation and examination of checklists that can identify the causes of risks thereby leading to effective CAPA (Corrective Active/Preventive Action). Alternatively, the experience of different quality managers in an engineering manufacturing capacity can also be used in the similar context that can be achieved through structured interviews with the individuals, discussion, and focus groups. It can also include surveys, scenario analysis and questionnaires for facilitation in the identification of risk. Brainstorming in this regard can be quite effective as compared to the superficial mechanisms that can include the formulation of checklists. The process can greatly help in drawing out the creative capacity of the individuals thereby reducing the potential risk for overlooking emerging and new issues (Cooper et al., 2014). A structured interview can also be quite beneficial and effective format that can require the adequate time allocation for the key participants for considering all the risks associated with the organization. Knowledge and experience is a vital part of the process; however, the historical data cannot block the creative assessment considering future prospects that have not arisen beforehand (Cooper et al., 2014).
Risk Evaluation and Qualitative Risk Analysis
Qualitative risk assessment is quite commonly dependent on the ranking and ordinal scales for the description of likelihood and consequences pertaining to the risks. The method is quite useful for the managers to understand and assess the risks (Miller, 1992). Moreover, it also allows the facilitation of the prioritization of the risk treatment together with taking into account the activities, plans, and processes that can act as a control or preventive measure. The qualitative risk assessment is also quite useful in the circumstances in which there is the insufficiency of the reliable and accurate statistical data. Moreover, it is also quite useful in the circumstances having cost and time constraint that prevents the managers from going through a more resource-intensive quantitative or semi-quantitative approach for risk identification and its subsequent analysis. In contrast, the quantitative approach in the risk management quite commonly encompasses the usage of numerical scale (ratio) for determining the probabilities and severity of the events instead of the nominal scales that are quite commonly employed in the qualitative risk assessment.
As part of the ISO 9001:2015 context, it is quite essential to consider the risk to be qualitative in nature; however, it can also be extended to semi-quantitative and quantitative approaches depending on the time and resource availability during the definition of degree of formality and rigour that is needed for planning and subsequent controlling of different plans and processes in ISO 9001: 2015 quality management system. The study will focus on the qualitative risk analysis and hence, provide the systematic use of the available information that includes the information documented as part of the risk identification and assessment process for the better understanding of the risks associated with the processes and its components under the domain of quality objectives. This step will encompass the assessment of the potential effectiveness of the existing control measures; determination of the severity of characterized risk, the likelihood of the severity or consequences that can arise and the failsafe planning for the potential failure of the control measures.
The ISO 9001: 2015 quality management system team can be considered as the best and reliable source of information pertaining to the deployment of the control measures for identification and assessment of the risks in terms of the associated consequences and causes. Under the circumstances in which the organization’s context is quite complex and high risk, it is quite essential to assess additional information to be gathered from different teams in an organization. Under the circumstances that require assessment of high priority risks, the quality managers and risk assessment teams can include the sources that include, process records, historical records, user experiences, industry’s best practices, product technical manuals and brochures, audit reports and published research reports and literature (Priede, 2012).
Information that can be utilized as part of the risk evaluation and analysis step can include empirical data and analysis, concern of stakeholders, historical data, and theoretical analysis and most importantly, the informed suggestions and opinions of the quality and risk management experts together with the project team (Cooper et al., 2014).
The steps required in the qualitative risk assessment encompass the following steps:
Listing all the possible process controls that are in place together with the acts for modification of the risks and subsequently analyzing its effectiveness.
Determination of the level and nature of the consequence (severity) of the risks and subsequently categorizing it (Haimes, 2015).
Assessment of the likelihood of the potential for the consequence to occur after the controls is in place as part of ISO 9001: 2015 quality management system.
Combination of the potential levels of probabilities (likelihood) and severity (consequences) for effective determination of the level of risk.
Evaluation of the exposure and potential fail-safe measures for each identified risk that can result in the desired outcome in the domain of ISO 9001: 2015 quality management systems.
Point out the priorities that are duly agreed by the management for the risk treatment, potential control measures, and most importantly, ensuring that the top management is the commitment in the domain of ISO 9001: 2015 quality management system.
Risk Treatment
The steps of risk identification and assessment require that they must be translated towards concrete preventive actions. As per ISO 9001: 2015 quality management system, one of the core considerations of the standard is to facilitate the use of preventive actions. However, there is no longer a separate clause for preventive action mainly because of its incorporation as part of the risk-based approach that is embedded in the quality management system (Deysher, 2014). There is not a specific requirement for the process of formal risk identification and assessment or even a documented risk management for the specific processes; however, risks and opportunities quite commonly need to be determined and subsequently addressed as part of the ISO 9001: 2015 quality management system. Considering the quality management system is to be used as preventive tools, it requires risks to be identified, analyzed, prioritized and most importantly undergone risk treatment actions.
Risk treatment action can encompass a number of potential steps that includes the identification of the feasible actions pertaining to risk treatment; selection of different risk treatment actions that can create value; and development of risk treatment actions. In this regard, brainstorming can result in bringing about the fruitful result for examination of risk treatment options. Hence, the options can include, seeking or avoiding the risk, altering the probability (likelihood), assigning and/or altering severity (consequence) values to the risk, sharing the risk, and most importantly, accepting the risk explicitly without further actions.
Risk treatment can include the following steps:
Identification of options for addressing the potentially high priority risks
Determination of the potential costs and benefits of different options
Selection of the best possible option for the treatment of the high priority risks
Development and implementation of the detailed action plans based on risk identification and assessment.
Making appropriate provisioning as part of the budgets for subsequent preventive actions (Cooper et al., 2014).
Monitoring and Review
The core steps involved in the monitoring and review phase includes the development of a monitoring plan for each of the following step:
Risk Owner (Risk)
Control Owner (Control)
Risk Owners (Treatment Plan)
It is also quite important to understand the importance of periodic monitoring of the treatment plans pertaining to how the risks and its controls. It is also quite important to delegate the responsibility of the potential preventive actions against each mentioned risk. Hence, it is also quite essential to look for adaptation of the optimal approach for the risk treatment steps. At the final stage, the organization must be able to set up the following processes:
Reporting and documenting of process pertaining to risk management, control monitoring, and review.
Reporting and documenting the process for analyzing the progress regarding the risk treatment-related plans.
Understanding the process for the derivation of lessons from the failures and successes associated with the quality management processes and hence, for communication of the information to different internal as well as external stakeholders (Cooper et al., 2014).
These steps conform to the very requirements of the ISO 9001: 2015 quality management system that requires the establishment, implementation, maintenance and most importantly continual improvement thereby resulting in the improvement in the overall quality management system of an organization that includes the processes as well as their interactions. The ISO 9001: 2015 quality management system also requires planning and consideration of risks as well as opportunities as per the requirements mentioned in clause 6.1, ISO 9001:2015 quality management system. It is also required to plan and subsequently implement appropriate preventive actions for addressing the actions. This would include the methods pertaining to measuring, monitoring and subsequent evaluation of different process and if needed, potential changes in the processes for ensuring that the outcomes would serve the intended purpose (clause 4.4: ISO 9001: 2015 quality management system).
The ISO 9001: 2015 quality management system also mandates that the firm should maintain the documented the information that is related to the extent of the necessary actions for supporting the successful operations of the processes. Retention of the documented information is also needed to extend the necessary confidence in the facilitation that the processes are the complaint against the ISO 9001: 2015 quality management system with the preventive actions that includes checklists, reports, and documents maintained to avoid potential non-conformance in an organization.
Analysis and Discussion
Organizational has both an articulate purpose as well as an established mechanism for the achievement of different goals and objectives. Most of the organizations strive in different activities for evaluation of every ongoing process and hence, formulate a plan for continual improvement in an organization. The evaluation requires questioning, verifying and subsequently redefining the very manner in which an organization maintains and carves out a viable market for the supply of their goods and services. However, ineffectiveness in organizational processes leads towards the failing in alignment of their corporate goals and hence, results in sale and business loss in the long run. It is quite necessary to refine and modify the mechanisms pertaining to the achievement of purposes that can encompass rearranging the role structures, relationships and subsequently, different managerial related processes. Regarding the achievement of organizational goals, it is quite essential to analyze the risks associated with the organization and its processes by the introduction of continual improvement and preventive plans. Apart from that, the management of risks is also one of the core considerations of an organization operating on an international scale (Ghoshal, 1987). Nevertheless, the treatment of risk and most importantly, uncertainty considering an organizational outlook require immediate consideration. There are a number of potential risks associated with an organization that includes general environmental, industry and firm-specific variables. However, based on the risks associated with the ISO 9001:2015 quality management system, the risks are summarized as under:
Based on the risk assessment matrices, a number of potential risks were highlighted as part of an organization. Among those risks includes the risks pertaining to interested parties, internal and external issues, HR, administration, maintenance, production and quality control.
Area: Admin and Maintenance
Process / Location / Factor Opportunity Hazard / Failure / Threat Impact of Hazard / Failure / Threat Risk Assessment Rating Control Recommended
S P RA = SxP  
Breakdown Maintenance NR Machine Disorder Issues in supply chain and order deliverance 4 2 8 Spare parts to be readily available and outsourced maintenance team to be contracted
To train maintenance section staff NA Lack of Skill Workers results in mishandling of the machine/Quality of work will not perform 4 4 16 Experience staff available & arrange regular training.
To hire 2-3 maintenance staff more NA Insufficient staff required Maintenance operations will be suffer 4 4 16 Hiring of maintenance staff must be done
Maintaining running parts inventory in Engg workshop NA Unavailability of parts in Engg store Maintenance time will suffer. 4 3 12 Running parts inventory must be maintained at a store.
NR Parts out of specifications Due to that maintenance activities will be suffer 4 2 8 Before receiving any part from store/vendor, checked/measured by Engg staff/technician
NR Unavailability of required tools Maintenance operations will be suffer 4 2 8 Arrange required tools through purchase by SCM Dept
Preventive Maintenance NR Machine was not available on given schedule Preventive maintenance couldn’t perform on Time, it may lead to breakdown activity 4 3 12 Before starting of new month, PM schedule send to concern dept through email
NR Preventive Maintenance Schedule not properly followed Breakdown of Machine 4 3 12 Preventive Maintenance Checklists are in practice and verified by Maintenance Manager
Maintenance through Outsource vendors/Service Providers NR Sometimes scheduling couldn’t meet with our time requirement Chances of maintenance time increases 4 2 8 Before providing machine to outsource vendor, a detailed summary sent/discussed to vendor
Utility Maintenance NR Generator breakdown Production on hold/ All factory operations stopped. 4 2 8 Generator needs to be available as a backup / Preventive maintenance schedule
NR Water treatment plant Production and quality process will suffer 4 2 8 Preventive Maintenance Checklists are in practice and verified by Maintenance Manager / Yearly Maintenance
NR AC unit Efficiency Loss / Time & Productivity Loss 4 2 8 Preventive Maintenance Schedule to be in place
NR General Building Maintenance (lights, paint works, door locks, glass maintenance, CCTV maintenance, UPS, Chairs, and workstations Production and quality process will suffer 4 3 12 Preventive maintenance schedule to be developed and implemented.
Cleaning & Hygiene of Factory NR Poor Cleaning & Hygiene of Factory May results in disease and bacterial growth. 4 3 12 Cleaning and hygiene monitoring checklist to be maintained, verified and validated.
Pest Controlling NR Pests / infestation May harm the quality of MEMS and NEMS product as well as process 4 3 12 Pest control measures to be in place
NR Pests / infestation May results in disease and bacterial growth. 4 3 12 Pest control measures to be in place
Date of Risk Evaluated: 19-01-2018 Date of next Risk Re-evaluation: 19-01-2019
Area: HR
Process / Location / Factor Opportunity Hazard / Failure / Threat Impact of Hazard / Failure / Threat Risk Assessment Rating Control Recommended
S P RA = SxP  
Recruitment NA 1) Hiring of a suitable person 1) Effect the Quality of Work 4 1 4 Interviews, questionnaire, reference checks, degree verification
2) Background Verification not done 2) Effect on working environment 5 2 10 3) If all steps of hiring process not been followed for any candidate. 3) It will affect the efficiency of concern department 5 1 5 Succession Planning NA If there is no Succession Planning in process It affects the future Leadership and future business 4 2 8 Structured Succession Planning is inducted into the system
Insurance and Health Management NA If there is no Health Insurance policy or employees are not insured It affects the moral of employee and their motivation 4 3 12 All MEMS and NEMS employees are insured in Group Health and Dental Plan
Separation NA Resigned Employee still not marked in system It affects the Payroll and there might be a chance that an extra salary will deposit into the resigned employee’s account 5 1 5 All Resigned Employees list must already be shared with finance department every month before payroll closing
Performance Management System & Appraisals NA Goal Settings, Biased opinion of Line Manager, unable to understand the criteria of PMS, Self-evaluation Wrong percentage of Increment, Failure to maintain uniformity, Wrong KPIs set, Employee dissatisfaction 4 4 16 . PMS training for all employees. Guidelines to avoid wrong evaluations. Review check is done by HR
Outsource training NA 1) No proper Training program 2) Could not get the program information 3) registration date missed 1)No professional development of people 2) Needed program can be missed 3) Participants could not get opportunity 4 3 12 1) Fixing timeline 2) Makeup lectures to be made available 3) Availability of trainer online
Date of Risk Evaluated: 19-01-2018 Date of next Risk Re-evaluation: 19-01-2019
Area: Interested Parties
Process / Location / Factor Opportunity Hazard / Failure / Threat Impact of Hazard / Failure / Threat Risk Assessment Rating Control Recommended
S P RA = SxP  
Partners / Owners NA Not finding value/return on their investment Business operations discontinuation 5 3 15 Effective Operational & Financial Controls are in place
Customers NA No Quality Goods & not on time delivery Business & Reputation loss 5 3 15 QMS Implementation
Employees NA Lack of on-time salary etc Too much staff turn over 4 3 12 Proper HR & Payroll system
No Safe Work Environment 4 3 12 HSE inspections & trainings
No Job security 4 3 12 Good Management & Staff relationship
International Suppliers (imports) NA No import related compliances Delays in shipments 4 2 8 Hiring and training of Competent Staff
Local Suppliers NA Delays in payments Weakening Supplier relations & delays in deliveries 4 2 8 Proper Payment mechanism in place
incapability to meet demands Hindrance in Supply Chain Operations 4 2 8 Supplier’s Pre-qualification & Evaluation Procedure in place
Service Providers NA Delays in payments Weakening relationship 4 2 8 Proper Payment mechanism in place
Not giving access to premises to perform services Unable to perform or delays in services 4 2 8 Service Contracts specifying all requirements with payment terms
Regulators NA Non-Compliance with applicable legal requirements Penalties, reputation & operation lesses 4 2 8 Admin team to be trained and inducted
Certification Bodies NA Non-Compliance with QMS requirement Non-conformities may cause systems collapse 5 4 20 QMS Implementation and training of teams
Banks NA Noncompliances of Local Bank’s policies & Procedures Operation losses 4 2 8 Hiring and training of Competent Staff
Neighbouring Industries NA Un-Safe & No Environment-friendly practices HSE violations 4 3 12 Periodic outside inspections, external audits, and testings for air monitoring and wastewater discharges
Date of Risk Evaluated: 19-01-2018 Date of next Risk Re-evaluation: 19-01-2019
Area: Production
Process / Location / Factor Opportunity Hazard / Failure / Threat Impact of Hazard / Failure / Threat Risk Assessment Rating Control Recommended
S P RA = SxP  
Inception of product and CAD Modelling NR Wrongful inception of product Issues in the long-run considering project management 4 1 4 Specifications and customer satisfaction needs to be understood and agreed on legally binding document
To train R&D section staff NA Lack of Skill Workers results in mishandling of CAD/CAM operations work will not perform 4 4 16 Experience staff available & arrange regular training.
To hire 2-3 R&D staff more NA Insufficient staff required CAD/CAM operations will be suffer 4 4 16 Hiring of designing and R&D staff must be done
Maintaining running parts inventory NA Unavailability of parts in workshop store Project time will suffer. 4 2 8 Running parts inventory must be maintained at a store.
NR Unavailability of required tools Absence of tools for research and development operations will cause delays in initial stages 4 2 8 Arrange required tools through purchase by supply chain management (SCM) dept
Mask Generation and Photolithography NR Machine breakdown Machine breakdown can result in missing crucial deadlines 4 2 8 Preventive maintenance schedule to be maintained, verified and validated by the Manager Operations
To train photolithography section staff NA Lack of Skill Workers results in mishandling of operations work will not perform 4 2 8 Experience staff available & arrange regular pieces of training.
NR Availability of raw material for substrate, photoresist layer, and photomask Machine stoppage and production loss 4 2 8 Arrange required raw materials through purchase by SCM Dept
Assembling and Sectioning To train sectioning and assembling section staff NA Lack of Skill Workers results in mishandling of operations work will not perform 4 2 8 Experience staff available & arrange regular training.
Packaging NR Issues in non-compliant packaging Delays in production order completion 4 3 12 Specifications of incoming packaging material should be examined and validated by the QA department
NR Untrained packaging operators Delays in production order completion 4 2 8 Need training for operators and validated through testings.
Date of Risk Evaluated: 19-01-2018 Date of next Risk Re-evaluation: 19-01-2019
Area: QA
Process / Location / Factor Opportunity Hazard / Failure / Threat Impact of Hazard / Failure / Threat Risk Assessment Rating Control Recommended
S P RA = SxP  
Inception of product and CAD Modelling NR Wrong design of product Issues in the long-run considering project management 4 1 4 Specifications of product to be acknowledged by HODs of R&D, Operations, and QA
To train QA section staff NA Lack of Skill Workers results in mishandling of CAD/CAM operations checking 4 2 8 Experience staff available & arrange regular training.
Mask Generation and Photolithography NR Anomalies in process parameters Possible issues in product quality and compliance requirements 4 3 12 Induction of experienced individuals and implementation of SPC tools
To train photolithography section QA staff NA Lack of Skill Workers results in mishandling of operations work will not perform 4 3 12 Experience staff to be made available & arrange regular training.
Assembling and Sectioning To train assembling and sectioning section QA staff NA Lack of Skill Workers results in mishandling of operations work will not perform 4 3 12 Experience staff to be made available & arrange regular training.
Packaging NR Issues in non-compliant packaging Delays in production order completion 4 3 12 Specifications of incoming packaging material should be examined and validated by the QA department
To train packaging section QA staff NA Lack of Skill Workers results in mishandling of operations work will not perform 4 3 12 Experience staff to be made available & arrange regular training.
Vendor Assessment NA Improper vendor assessment of the raw material and part suppliers Lack of assessment could lead to quality issues on production lines 4 4 12 Vendor assessment under the scope of ISO 9001:2015 needs to be developed and suppliers are evaluated on yearly basis. Re-evaluation should be verified and validated.
Calibration NA Expired Calibration of measuring and equipment’s components Reduced quality of products, more recalls, life of equipment deteriorates 4 4 16 Calibration of equipment and components (sensors) to be conducted on the yearly frequency that is verified and validated.
Date of Risk Evaluated: 19-01-2018 Date of next Risk Re-evaluation: 19-01-2019
Maintenance
Maintenance is another core aspect that can be considered in the domain of ISO 9001:2015 quality management system; mainly, because of its potential to impact product quality and customer’s satisfaction. Maintenance activities and practices have evolved in order to meet the very needs of the ever-changing industrial environments. The function has caused the evolution of workmen from reactive fixers to the craftsman to proactive maintenance professionals. This evolution has allowed implementation of ISO 9001:2015 quality management systems to be readily implemented into maintenance management. The maintenance progress can be greatly visualized through the capability for predicting the reliability analysis and assurance. This aspect can result in meeting the very requirements for different types of equipment reliability that are demonstrated as part of ISO 9001:2015 quality management system under the domain of process centeredness approach.
The process-centered approach to management is another system that can result in managing the company’s activities as a process. The process is readily managed via ISO 9001: 2015 quality management system which is enlisted in Plan-Do-Check-Act (PDCA) cycle as a process. However, some of the maintenance activities are not directly linked to ISO 9001: 2015 quality management systems that have particular management characteristics. The incorporation of PDCA as part of the structured maintenance management activity can be considered as a best practice for propelling the maintenance management towards the reliability analysis domain. Maintenance could be defined as the management of degrading engineering materials that can include systems and equipment so that their performance can be retained within the feasible operating parameters.
Under the domain of machine breakdown as highlighted in the risk management, the reliability studies can be conducted for depicting the possible scenarios for a machine and critical equipment stoppage that could include processes like photo masking, photolithography, assembling and packaging units. Stress in any equipment can accelerate the deterioration of the metals and its components in the corrosive environment. Hence, the operational stresses lead the systems and equipment towards the failure. It is quite essential to maintain the equipment within the operational limits and environment so that the equipment’s reliability can be readily achieved. The core components that could be considered in the maintenance activities (relevant to PDCA cycle) include the following:
Protection of components from environmental and operational stresses.
Monitoring the conditions of the equipment
Anticipating the replacement of components before the failure threshold level is achieved for every equipment in the production line.
The components of the maintenance management system can also encompass the preventive maintenance, conditional maintenance and most importantly, planned overhaul. Hence, it is quite important to point out the potential maintenance activities.
Preventive Maintenance
The preventive maintenance measure can include the facilitation of the rate of degradation of equipment. It can include the adjustments, application of coatings, and cleaning of the equipment for the retention of the components within the specified operating conditions. Apart from that, the chemical and physical control of the applied media to the operating environment thereby having the potential to enhancing the stresses on components beyond their designed operational parameters.
Conditional Monitoring
Conditional monitoring can play dual roles considering the maintenance process that includes regulation prior to preventive maintenance. It can also serve as a potential tool to alert against the impending failure of equipment.
Condition monitoring provides an insight whether it is necessary to conduct the preventive maintenance against the environmental stresses. Apart from that, the conditional monitoring can also serve to facilitate the identification of rate of degradation for facilitating the threshold level for failure. Conditional monitoring also provides a measurement of the rate of degradation of equipment.
Planned Overhaul
Planned overhauling of equipment and systems takes place prior to significant failure having the rate of degradation to exceed the threshold failure limit and is observed through conditional monitoring activities. This aspect involves the disassembly, replacement of component(s) and subsequently, reassembling of the types of equipment and components.
The process of preventive maintenance, conditional monitoring, and planned overall are repeated throughout the life cycle of the types of equipment.
Considering the maintenance activities, the ISO 9001: 2015 quality management system can be implemented as under:
In the “Plan” domain, it is of ample importance to achieve the reliability depending on the context of the preventive maintenance, corrective maintenance, and planned overhaul at the individual component level through the documentation, economic, human and technical resources for the overall achievement of reliability.
In the “Do” domain, it includes the incorporation of actual work instructions that need to be performed and hence, the options that are necessary prior to execution of the task(s) pertaining to record keeping and requirement assessments of the reliability studies.
In the “Check” part, it is essential to identify the achievement of the reliability task(s) considering the contexts of the economic, human and technical resources. Hence, the measurement of the effectiveness and efficiency related to the plans can help in the determination if the waste through the unwanted activities and errors has occurred. It can be achieved through time-motion studies and takt time calculations. Hence, this can result in the tracking of the core resources for the determination of the condition when they are beyond the allocated or proposed resources during the planning phase. In this regard, condition monitoring can also serve as a verification mechanism for assessing the assured reliability. This measurement can provide an intimated at the analysis stage so as to assess the status of the component for potential improvements. Apart from that, the Pareto Analysis can also be conducted for analyzing the root causes that could have caused through improper operations, harsh environment, lack of maintenance, and recommended the end of life of equipment and components.
In the “Act” part, it encompasses the action that can be taken as part of the result of verifying and validation for successive feedback mechanism for planning phase. This phase can also provide a feedback for any potential adjustments in the preventive measures, conditional monitoring, and planned to overhaul activities to attain the desired reliability levels as per the context of available resources.
The PDCA cycle application can facilitate the consideration of ISO 9001: 2015 quality management system that can provide reliability and assurances that can include the following aspects:
Feedback
Measurement
Keeping the records
Work Instructions/SOPs
Identification of resources
The maintenance management can facilitate the ground for implementing continual improvement activities for the achievement of the overall reliability of equipment and components (Lewis, 2018).
Administration
In administrative domain, the overall housekeeping of the facility is another important consideration considering the risk assessments. The hygienic conditions of the MEMS and NEMS manufacturing plant are also of ample consideration as it could affect the process as well as the health of the personnel. Hence, in this regard, a number of measures can be implemented that can include the cleaning and hygiene monitoring checklist that needs to be maintained, verified and validated with internal stakeholders. In order to understand the potential complexities pertaining to today’s MEMS and NEMS manufacturing plant, it is quite important to incorporate stakeholders’ approach to answer the issues pertaining to responsibilities for corrective and preventive actions. The responsibility for maintaining the overall company’s hygienic condition should be verified by the supervisor and admin personnel and could be verified by the general operations manager. As highlighted by Smallman and John (2001), the topic for occupational health and safety of workers can be established at the level of board members and is quite important and could be detrimental for the corporate profits and most importantly, reputation. Good performance in the domain of occupational health and safety domain can be considered as an important part as part of the corporate culture and hence, also a source of pride among the management. Apart from that, the arguments in favor of implementation of occupational health and safety measures are also evolving as part of legal compliances on local and international levels for the achievement of exceptional business performance and competitive advantage. Occupational health and safety cannot be visualized as a separate responsibility and function; however, it can be viewed as the potential consequence considering the broader perspectives of competitiveness, target productivity and most importantly, profitability that can be considered explicitly or implicitly function of the total quality management domain. Hence, most of the manufacturing firms take the route that is slightly less sophisticated are leading towards a more strategic approach for the occupational health of the workers. The core reason behind it is that the potential avoidance for any occurrence of occupational health and safety incidents at the facility can result in loss of corporate reputation and subsequently, legal consequences in the long run. The performance considering occupational health and safety of the personnel can impact the corporate reputation of the company; however, the impact is mostly negative in nature rather than the positive outcome. It can be viewed that a poor consideration of the health of the personnel can result in a significant competitive disadvantage by impairment of the company’s image in the eyes of one or more of its internal as well as external stakeholders. Hence, it requires successful management of the occupational health and safety and housekeeping of the firm that insists on reducing the liability of firm that can result in the poor occupational health performance. It can also reflect that a failure in the relationship of principle-agent can result in investors to react negatively to the health incident. Considering the stakeholders’ approach, most of the company’s senior management has a reduced outlook pertaining to the ongoing outlay for the items related to occupational health and safety. Also, the financial returns on these investments can also be quite reduced and these actions could be deemed unpalatable in the long run. Hence, for the consideration of the occupational health and safety of the employees, it is quite essential to consider that the outlooks of occupational health and safety lie beyond the monetary gains. Hence, it is quite essential to incorporate the aspects of occupational health and safety with the domains of business excellence thereby leading to the determination of occupational health performance. This issue can have arisen from the lack of different appraisal investment technique that can possess a quasi-ethical stance that can be taken by the board of directors. The answer can also lie with the utilization of a more novel metrics that can be related to the social performance of the company and it can be viewed that these actions are evolving in companies as well. The inclusion of meaningful occupational health and safety related performance metrics can result in enhancement of organizational culture and hence, provide the company with the enhanced outlook for performance appraisal for internal stakeholders. The potential damages caused by the lack of basic occupational health and safety measures depending on the developed and under-developed countries economy can have a significant negative impact on the organizational culture and firm performance. Hence, it is quite important to link the social performance of the company, quality, productivity and most importantly financial performance as the key for establishing strong bond within the organization for facilitation of balancing employees, managers, and board of director’s responsibility for nurturing the overall well-being of an organization. In this regard, the aspect of the reputation management also needs to be addressed from the cultural rather than the brand-related point of view. Although, the requirement for attaining return of investment on different aspects of health-related concerns is quite commonly seen as unpalatable for most of the managers as well as directors; however, the investment incurred as part of illnesses and diseases can result in enhancement of badly applied or an insubstantial amount of funding. Hence, improving the performance requires that the targeting of resources. Hence, this aspect is equally important in facilitating occupational health and safety related investments as it is for the investments for enhancing production and commissioning of a new production plant.
Apart from that, the issues pertaining to the pest control measures are another significant issue in the domain of occupational health and safety. Hence, pests can pose significant risks related to the overall well being and health of the company’s personnel thereby resulting in different risks that include absenteeism and lack of productivity of employees. Hence, to address this issue, it is quite essential to have pest control measures in place. It has been observed that less than the 1% of all the species is considered as pests and subsequently affect lives, damage the property and subsequently, threaten the well being of the personnel at work. On an annual basis, the termites and insects can cost Americans around $1.5 billion in expense pertaining to control and damage caused by the pests that are greater than the combined cost considering all the natural disasters in the United States during a year. Structured pest control measures are much more inspired by the emotional outlooks as compared to the economy. The core reason behind it is the fear of different types of arthropods that includes spiders and insects to be third most common phobia while being the spiders as the second most feared insect besides snakes. Fear, being quite often unfounded, could be the stimulus for initiation of different pest control measures as some of the pests can cause significant danger to the human health at the workplace. Most of the health concerned institutes associate the structured deployment of pest control measures to include the potential for transmission of disease and can also have a significant psychological impact on the human. As part of the pest control measure, it is quite essential to hire or have a contract with Pest Management Company that can provide services to the company on regular basis. The very same pest control services can be achieved in-house as well; however, hiring a specialist only for the purpose of pest control could not be cost-effective and regular training costs of the personnel would also be incurred on annual basis. Hence, outsourcing the contract for pest management system deployment could be quite providing a feasible solution for the company as well as the personnel alike. The very concept of integrated pest management can provide an outlook for identification, assessment and subsequently, selection of the best possible solution for the organization replacing the conventional methods of routine spraying of surfaces and baseboards (Illinois Department of Public Health, 2018). Most of the common infestation includes insects like termites, rodents and other insects within a company. Hence, the separate frequency for pest control measures should be selected. For gel application on the exits and entrances of the company’s peripheral boundaries should be cordoned off for any potential infestation to come in contact with the company boundaries from outside environment on monthly basis. For the internal controls, spraying can be conducted on monthly or bi-monthly basis depending on the external environmental conditions as well as a location of the facility. For the rodent control service, it is quite essential to incorporate the rodent traps in the facility that must be mapped for ease of verification and validation.
Human Resources
Under the domain of HRM, it is quite evident that training and development of maintenance staff is a critical risk that needs to be addressed. Training and development of an individual in an organization plays a pivotal role. Most of the fresh inductions within the MEMS and NEMS organization require prior training together with a sound educational credential that can support the individuals during his/her tenure. According to clause 6 of ISO 9001: 2015, quality management system, it is quite essential to have the competencies and skills pertaining to the provisioning and production of quality products.
As per Dearden et al. (2000), vocational and on-job pieces of training play a vital role in enhancing the skill level of the workforce together with ensuring a long-term and sustainable economic performance of an individual. The issues pertaining to productivity can also be addressed through external as well as in-house pieces of training of the workers. In this regard, the employer can provide fund partially or fully for the training and development of its organization’s workers in the sole hope for getting enhanced revenue and productivity in the long run. It has also been observed that the workers who are highly trained with professional certifications and vocational pieces of training can receive comparatively higher wages as compared to the untrained employees. However, the relationship between the productivity gains and wages enhancement can be different depending on the very structure of the product and labor markets. It is also highly dependent on the employer who is willing to pay for the vocational training and development programmes. Considering a neoclassical point of view for the labor market, the wages can be considered as a direct measure of the marginal products considering a competitive market. However, there are certain instances in which the employers can also implicitly pay for the professional training and development of its employees at the cost of reduced wages during their training phase that has been subsequently been increased after the completion of training. In this case, it can be observed that there could be an increased number of observed wages as compared to the productivity mainly because of the incorporated training costs that can readily nullify the direct dependency of productivity and net earnings. Hence, the training and development of the maintenance and other technical staff should be linked with the incentive program so that the company cannot incur excessive costs during the time span of the training period (Dearden et al., 2000). Verification and validation of the training can be achieved through training evidence and testing mechanisms.
Besides the training requirements underlined in the ISO 9001:2015 quality management system, it is also quite essential to conduct different awareness sessions pertaining to the quality management system. The session can act as an induction training session for the newly inducted employees and refresher session for previously inducted employees. An internal audit can also aid in the verification of the extent of the awareness of the person against the pre-defined SOPs and procedures.
Competence criterion of the employees also plays an important role in the implementation of the objective as provided in the ISO 9001:2015 quality management system. Through internal audits, the competence can be analyzed that includes the knowledge, skills, and ample knowledge for meeting the quality requirements of products and hence, lead to enhancement of customer satisfaction (Wicks, 2018).
Interested Parties
As per the clause 4.2 of ISO 9001:2015, there is a significant need for understanding the expectations and needs of interested parties. Interested parties can be defined as the group of persons who can either impact or are affected by the very actions of the organization. Internal interested parties can include the staff, management and most importantly shareholders or board of directors. The internal interested parties are inherently the face of the corporate image and hence, the ones that can interact with other parties.
Considering the external interested parties, it can include the customers; however, it can also include the aspects of end-user customers as well. This domain can also include international suppliers, local suppliers, service providers, regulators, neighboring industries, certification bodies, and banks as mentioned in the risk assessment matrix.
Legal, governmental and regulatory authorities can also impact the business activities and subsequently customers in the long run. Changes in some of the legislation or new initiatives that could be increased in the minimum wage of the workers have the capability to impact the business activity of the firm. Also, in this regards, the relationship with financial institutions can be considered as a mean for viable business operations (CG Business Consulting, 2018).
Production and Quality Assurance
Production and quality assurance are two of the most important component of any manufacturing unit. In this regards, ISO 9001:2015 quality management system can help in the potential identification of the quality and reduced production issues as part of a closed loop mechanism that includes proactive monitoring of non-conformances throughout the MEMS and NEMS manufacturing facility. It includes the issues arising from supplier, manufacturing non-conformances, external customer complaints along with internal and external audits.
The quality management system is not only limited to the quality assurance; however, it can result in improvement of the complete process flow together with the reduction in waste production while enhancing the workers’ capability to work. In this regard, the opportunities can include enhancement of labor relation, reduction in COQ (Cost of Quality) and hence, enhance the OTD (On Time Delivery) of goods to the customers thereby leading to smooth supply chain operations.
For any potential internal as well as external non-conformity, it is quite important to address the aspect of root cause and Pareto chart analysis and subsequently, issuing CARs (Corrective Action Request) to concern departments so that it could lead towards timely and effective preventive and corrective actions to be implemented thereby reducing the probability of the non-conformity to reoccur (Psomas and Antony, 2015). For making the compliance of the system against ISO 9001:2015 quality management system, it is quite essential to go through following phases for successful implementation:
Clause 4: Definition of interested parties that includes identification and risk assessment together with a definition of system scope.
Clause 8.7, 9.2 and 10: Definition and implementation of continual improvement activities by following PDCA cycles for every activity and processes having the preference of preventive actions over corrective actions.
Clause 5-7: Recording the evidence for training for the achievement of direct continual improvement tasks.
Clause 8: Definition of product realization phases that encompasses project planning, sales and marketing, research and development, purchasing, manufacturing and subsequently, testing and quality assurance of equipment.
Clause 9: Development of monitoring and measurement activities pertaining to the critical process for interested parties and follow PDCA cycle to attain continual improvement (Anderson, 2018).
All these phases have been elaborated as part of the risk management process as it could lead towards processes and systems improvement. Apart from that, internal audits and management review meetings (MRMs) can also be beneficial for assessing the compliance of system on yearly basis thereby providing actionable outlooks for the firms with timelines.
Conclusion and Recommendation
All in all, the quality management system can provide an enhanced outlook for the MEMS and NEMS manufacturing facility and can result in better business prospects. The quality management system can provide better compliance considering corporate and legal requirements of industry thereby enabling inclusion of lean and six sigma quality programs having the goal to improve the quality of an organization. The application can also aid in the unification of quality, manufacturing, human resources, supply chain, maintenance and administration departments towards a single goal of continual improvement for enhancing corporate image. Using these measures, there would be the significant shift from reaction to prevention outlook by a deployment of stringent monitoring and measurement prospects as part of the quality management system. The combined capability of the system would allow formulation of the rapid identification, evaluation and CAPA methods to be implemented thereby leading to the reduction in quality recalls. The knowledge can also serve to improve future product designs, optimization of production processes and (if necessary) swifter ramping up of production capacities. Risk assessment can serve the purpose to look for potential areas of opportunities and risks associated with each area of interest. Hence, it can provide an insight to the non-conformances that could have a high probability to occur in the long run.
As part of the study, it is highly recommended that the integration aspect of the quality management system with other management systems should further be explored and analyzed. ISO 9001: 2015 quality management system can also be integrated with other management systems that can include ISO 14000:2015 and FSMS 22000:2005 via integrated management system framework. This would provide the significant outlook for the organizations to deploy measures that can meet the requirements of all the implemented systems in a company (Wright, 2000). Apart from that, reliability studies under the domain of ISO 9001: 2015 quality management system can be further conducted to attain a further understanding of machine and component’s FMEA (Failure Mode Effect Analysis). Nevertheless, conduction of reliability analysis could provide extensive insight on different maintenance activities pertaining to MEMS and NEMS manufacturing units.

References
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Appendix A: Questionnaires
Provided to RA in separate file.

Appendix B: Consent Letters
Supplied to RA in separate file.