This is the project related to quality assurance and quality control. The aspect majorly covers under this is about improvement of working quality through usage of different models and techniques so able to provide efficient products to consumers.
- what is TQM?
- What are the different objectives of TQM?
- What are the different benefits of quality systems?
- What are the different steps that involved in PDCA cycle?
- Provide brief description of REMS?
- What do you mean by quality systems model?
- What do you mean by quality management?
- What are the different primary elements of TQM?
Section B
1 Total quality management
Total quality management is way to deal with make business subjective and successful. As indicated by this idea, representative's execution can, measures as far as change and quality. It is otherwise called add up to profitable support, portrays an administration ways to deal with long haul accomplishment through consumer loyalty (Henry and Adewale. 2013). By utilizing this idea, all individuals from an association partake in enhancing forms, item, administrations and the way of life in which they work (Total Quality Management 2016). Toward the end, one might say that, It is a methodical strategy for the disposal of waste inside a generation framework in the organization. Organization can receive this technique with a specific end goal to limit the wastage of creation.
2 Objective of total quality management
Total quality management is the colossal approach which guarantee that nature of items get kept up. Organization dependably need to give quality items to its shoppers so they feel fulfilled (Assarlind and Gremyr, 2016). This can be acquired through TQM process on the grounds that by along these lines refered to firm will have the capacity to improve effectiveness of tasks and can have the capacity to component wastage from the framework. Add up to is the immense application that can bolster in distinguishing circle fall in the framework and enhancing these issues. On other hand changes in laws dependably make issue for the association to roll out improvements in its tasks. The major objective of the total quality management application is to improve the quality of the product and services by eliminate wastage and additional cost from manufacturing and production procedure.
3 Benefits of quality system
- Quality framework techniques serves to change in organization's business, stock esteem and workers development . It is anything but difficult to gauge in various execution.
- Another preferred standpoint of this strategy is in increment the client esteem, it gives the consumer loyalty by enhancing the activity fulfilment in workers of the organization.
- Quality framework system enhances the nature of execution in the business (Bo and et.al., 2015).
- It likewise advances the consumer loyalty by giving them nature of administrations in the business.
- The real quality of this method to beat the blunder during the time spent administration
- By use of quality system within the production and manufacturing activities, company can eliminate the additional wastages from the business and improve quality and efficiency of product and services.
4 Steps of PDCA
The Plan- do- check- Act have major four stages for improve quality and effectiveness of product and service. This technique is majorly use in the production and manufacturing activity and process for improve quality of services. Following are stages of this PDCA model-
Plan- In this stage involves assessing a current process and new process. Company have to focus on what type of outputs that are desired to achieve. For address that outcome a systematic plan can develop by company.
Do- The do phase allows the plan from the previous step. In this planning and developed strategy going to implement in action. Company actually implement plan in the real action so as desired outcome can achieve (Jacobs, Swink and Linderman, 2015).
Check- Once the action has taken by the company then in the next stage it is very important to check and monitor that action and activities.
Act- In this stage, company again take action to improve the activities and outcome.
5 Hazard analysis and critical control points
This technique mostly used in the process of food safety and protection. It is a systematic preventive approach to food safety from biological chemical and physical hazard in production processes (Chaudary, Zafar and Salman, 2015). It assists to the users to overcome the uncertain hazard and risk from the food production so as high quality of food can deliver to the customers. It can be used at all stage of a food chain including packaging, distributions, production etc. This system allow both industry and government to allocate their resource in auditing of safe food production procedure.
6 ICH objectives
There are major three objectives of ICH Q10 that is achieved product realization, Establish and maintain a state of control and facilitate continual improvement (Haider and et.al., 2015). To achieve product realization is one of the major objective of ICH Q10 under which system allows the delivery of products with the quality so as patient requirement can effectively fulfill. It implements in the process for improve quality of service so s patient can improve their health. Another objective is to establish and maintain a state of control by which company can effectively monitor the quality of services and process (Henry and Adewale. 2013). Quality risk management can use to identify and monitor control system.
7 FMEA and its area of use?
Implementation of FMEA in the process of production and manufacturing is to overcome associated hazard and risk and improve quality of product and services. In a general term it can be said that Failure mode and effects analysis is a structured way to identify and acknowledge the associated risk and hazard in the production and manufacturing (Haider and et.al., 2015). It is a effective in evaluating both new and existing process within the company. It is a structured was to address the problem associated with the procedure through which quality and effectiveness can automatically improve.
8 Quality risk management for facilities and equipments
The main aim of quality risk management and equipment is to eliminate the unwanted risk and hazard from the business (Jacobs, Swink and Linderman, 2015). With help of this risk management process, company can automatically overcome the hazard and uncertain hazard from the services and product. There are various kinds of process, equipment and facilities that can use by organization for improve the quality and overcome the unwanted hazard and risk from the process. The most important aspect of risk management is to overcome uncertain risk from the process, product and services.
9 Explanation about the corrective action and prevention action
The corrective and preventive action is the improvement to an organization processes taken to eliminate causes of non conformity and other undesirable situation from the organization. With help of this aspect uncertain hazard, risk and undesirable situation can easily eliminate from the procedure (Assarlind and Gremyr, 2016). CAPA is generally used to being improvement and efficiency within the organization process, product and services through which objective can effectively address.
10 The activities that should be conducted to mange and continuously improve the pharmaceutical quality system
The process and product quality monitoring system includes several activities that are as follows-
- Use superior risk management to establish the control strategy
- Supply the techniques for measurement and analysis of parameters (Assarlind and Gremyr, 2016)
- Assessment if the parameters and attributes that is assessed in the control strategy
- Identification of the sources of variation that affect process performance and product quality.
- In order to design space, it is provided knowledge and effective information.
11 The objective of FDA guidance on quality system approach to pharmaceutical GMP regulation
The main objective of the FDA guidance on the quality system approach is to performing and handling test protocols with chronic protocols. It assists in enhancing the speed and quality of the process. It is responsible to protect the public health by ensuring the safety, efficacy and security of human and veterinary drugs, biological products and medical devices. It ensures the safety of our nations food supply, cosmetics and products.
12 Quality system models
The major aim of quality system model is to improve quality and effectiveness of the product and services in the organization and eliminate wastage and additional cost from production and manufacturing procedure within organization. (Chaudary, Zafar and Salman, 2015) There are various kinds of the quality system model that is total quality management, six sigma, lean production, ISO 9000, continuous quality improvement model, Kaizen, Bench marking etc. These all models have main aim is to continuous improve efficiency and quality so wastage can automatically eliminate. The quality system model gives all detail knowledge and information regarding improvement in services and product in the organization.
13 How are nonconformities and deviation handled in any quality system
Nonconformities refer to the requirements of a project that are not fulfilled as per the specifications. This in turn results in deviation from the previously undertaken plan to carry out the project. Both of these occurrences should be completely avoided by referring to the 8 management standards of ISO9001 that emphasizes the organisations to accurately meet the undertaken standards of quality where falling to rectify any non-conformity results in continuing the errors by together resulting in increasing the costs required to entirely rework or replace the project (Bo and et.al., 2015). This also leads to loss of consumers and quality accreditation, etc. A CAPA program also known as corrective and preventive actions has been designed to handle any such measures of deviation and non-conformities.
14 Explain the ISO standard related to risk management
The risks are known to make a negative impact on the organisations to a great extent. It directly affects the economic performance of the organisation by together impacting upon its professional status in the market. Beside this, it also brings negative environmental, societal and safety related results at the workplace that in turn necessitates the firms to effectively manage such existing risks and efficiently perform in such uncertain environment (Assarlind and Gremyr, 2016). For this purpose, ISO has been framed with its standards involving the measures for managing risks. ISO 31000 is referred to be the family of such significant principles and is codified by the International Organisation for Standards. There are 2 such crucial aspects namely ISO 31000:2009 specifying the principles and general strategies for managing risks. Another is ISO 31010:2009 detailing the techniques related to the assessment and management of risks.
15 Describe in brief REMS
REMS is basically codified as Risk Evaluation and Mitigation Strategy which is mainly used with a purpose of managing some severe risks that are associated with the risk of using any biological product or drugs, etc. It is an obligatory norm which is required to be followed if instructed by the Food and Drug Administration (Henry and Adewale. 2013). REMS mostly includes a medication guide, communication plan along with a patient packaging system to ensure a safe and secured use of organic or medicinal products. It together consists of a timetable to assess the REMS with approval from FDA before using a newly introduced product. REMS for one medication differs from that to the REMS of another medicine.
Section C
1 Quality management detail
This is the concept that is applied within organization for improve the productivity and quality of product and services so as business can gain effective success and profit. It is a process under which firm uses several approaches, systems and methods that can help to improve quality of business and also improve customer satisfaction and loyalty for long term. It is very important for company to use and implement effective methods and measures of quality management so as desired outcome can obtain in effective and efficient manner (Bo and et.al., 2015). The major component of quality management is quality planning, quality assurance, quality control and quality improvement. Company have to focus on these elements of quality management for increase the effectiveness and productivity of product and services. In a simple word it can be said that this concept is the act of overseeing all activities and task required to maintain a desired level of excellence. In order to implement measures and process of quality management, company have to determine quality policy, creating and implement quality planning and assurance and quality control and quality improvement.
2 Primary elements of Total quality management
Total quality management is the method of the quality management that helps to increase efficiency and quality of product and services. In this aspect, all members of organization participating equally within management process and improve quality and effectiveness of product and services (Chaudary, Zafar and Salman, 2015) There are various elements o TQM approach that required to focus by corporation. Total quality management elements includes ethics, integrity, trust, training, team work, leadership, recognition and communication. Ethic is a discipline concerned with good and bad in any situation. At the time of implementing quality measures within company, organization have to follow some ethics. In addition to this, integrity is another element that implies honesty, morals, values etc. Company have also focused on trust and loyalty at the time of deliver product and service in the market. Organization also have to focus on training and development, team work, leadership etc By focus on each element, firm can successfully implement total quality management approach within company and improve quality of product and services.
3 General quality risk management process as per ICH guidelines
Following are several stages of quality risk management process-
- Risk assessment- It is the first and significant stage under which information organize to take a risk decision in the risk management. In this company suppose to identify risk associated with process of business.
- Risk identification-This is the systematic use of information to identify potential source of harm referring to the risk and problem (Haider and et.al., 2015).
- Risk analysis- It is the qualitative and quantitative procedure for linking the probability of occurrence and severity of harm.
- Risk evaluation-In this stage company compare the estimated risk to given risk criteria by use of qualitative and quantitative scale to identify the significance of the risk.
- Risk control- In this phase, company implements action for take risk management decision. It has main purpose is to reduce the risk to an acceptable level.
- Risk reduction- In this stage, company revisit risk assessment in order to assess and evaluate any required changes in the prices. It helps in overcome chance of risk within the process.
- Risk acceptance- It refers to take the decision to accept the risk.
- Risk communication- In this information about the risk and risk management share between the decision maker and other stakeholder.
- Risk review- In this stage company have to look upon the reviews that include reconsideration of risk acceptance decisions. The process should be utilized for the events.
4 GMPs and the concepts of modern quality systems
It discusses how modern, comprehensive quality systems provides for full compliance with CGMP regulations. With help of this quality system, quality of product and services can easily improve in effective and efficient manner (Jacobs, Swink and Linderman, 2015). In addition to this, quality risk management is a valuable component of an effective quality system framework.
5 Management responsibilities in quality system models
It is the great responsibility of management to understand the model of quality system in order to gain effective results and outcome. It is also a responsibility of management to look toward the process and significance of quality system model that assist to company in increasing the quality and effectiveness of product and services.
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