The Role Of A Corrective And Preventive Action Program In Investigating Problems And Cost Reduction Activities Within

The Role Of A Corrective And Preventive Action Program In Investigating Problems And Cost Reduction Activities Within Industrial Organizations

Industrial organizations focus on innovations that translate in to growth for their businesses in terms of; an increase in profits, customer satisfaction, problem reduction and cost avoidance. For this to happen there is need for implementation of measures that will result to a more thorough systemic investigation of the problem in order to ensure that mistakes are not repeated. A corrective and preventive action is part of the measures that need to be installed in all organizations. It involves a study of a particular problem and a root cause analysis that determines the corrective action to be taken. The corrective action helps analyze the cause of the problem and guard against a recurrence of the same problem. The initialization of a corrective and preventive action program determines the sequence of events that should be followed incase of a problem in the organization. This ensures that by studying the events before a discrepancy an organization can observe a similar trend of events before the discrepancy occurs and averts the situation. Preventive action includes preventive maintenance, investigation and reviews and other forms of risk aversion activities.

In case of discrepancies many organizations focus on culminating the problem as soon as possible without analyzing the cause of the problem. This results to reoccurrences of the same problem over and over again leading to a waste of time and resources not to mention in most cases loss of customer credibility and delays in the industries operations. With these problems the company seems destined for eventual economic failure. This thesis will address the importance of a corrective and preventive action program in investigating problems and reducing an industries cost. In order for a company to succeed it needs to implement a Quality Management System that will enhance continual improvement for the organization as well as customer satisfaction. Data was gathered from various publications that detail previously conducted studies.

CHAPTER 1

INTRODUCTION

A quality management system is imperative for an organization to manage costs and risks, increase its overall efficiency and productivity, assess and recognize opportunities that will lead to growth and increase customer satisfaction. If proper planning and implementation is done there is an increased customer satisfaction resulting to customer loyalty and repeat business, an upward trend in the market share, increased operational efficiencies and company reputation. A company will also be in a position where they can recognize and capture market opportunities, motivate their employees, cut production costs and take advantage of these factors to boost them ahead of their competitors. Organizations are also required to regularly update these quality management systems to generally accept industrial practices to ensure their operations remain optimal. FDA and ISO certifications are also issued to ensure that the company is in accordance to the governments’ regulations. Both of these mandate an organization to implement corrective and preventive actions in order to ensure continual growth in its operations and profits. These CAPA regulations have been implemented in various organizations and have been proven to be an efficient and optimal way to ensure the success of an organization.

The CAPA system when implemented in an organization can only function optimally if the company is able to maintain the program as the demands grow. This is ensured by constant analysis, review and application of the changes (Gale, 1995).

This thesis will focus on the benefits of implementing CAPA system in investigating problems and in implementing cost reduction programs for an organization. It will also focus on the role of the CAPA system in ensuring that all these benefits translate into customer satisfaction and a higher profit growth for the company. This paper will also focus on explaining the meaning of the CAPA system. This thesis will target in promoting the implementation of the CAPA system in ensuring better investigation of problems and as a result ensuring that recurring errors are eliminated. This in turn is supposed to translate to cost reduction and continual improvement for the company.

Background of a CAPA System

The role of a Corrective and Prevention Action (CAPA) program to an organization is considered to be of critical significance in the ISO 9001:2000.  A well planned and implemented CAPA system would deliver a higher profit return in all of the organizations investment in technology. The benefits of such a CAPA system are innumerable and would extend to all areas in the organization. (Bailey, Valerie 2003).

ISO 9001:2000 has given one of its guidelines as a quality management system that has to be documented, tested, measured and assessed. It stresses on the need to establish an organization that will use its resources to produce the highest quality products and services targeted for customer satisfaction. A CAPA program is also mandated by the FDA. Due to this emphasis companies implement such programs as a necessity to be approved but for a company to reap most there is need to stress the importance of such a system as well as its roles in ensuring that there is less production costs for the company and more customer satisfaction. In 2006 after conducting a study FDA concluded that of all the companies it sent warning letters to concerning CAPA related issues, only 50% complied immediately(Journal of Validation Technology, 2007).

The ISO requirements emphasize the implementation of a CAPA system as an indispensable part of a Quality System. If implemented and given enough time to take effect it eventually leads to better quality products and services, cost reduction in production and overall incurred costs and more customer satisfaction and retention. These factors then work towards an increase in the profit margin for the company ensuring that there is better worker motivation and company growth.

Most companies usually get flustered after implementing such a CAPA system because they expect the results to be arrived at immediately. These benefits cannot be achieved at immediately and a CAPA system needs time to take root and make an impact n the overall running of the company.  The effects of a CAPA system are not only long term but extend across all areas of the enterprise. They however require time before they are assessed and condemned as ineffectual (Gale, 1995).

CAPA systems are part of Quality System in particular the auditing procedures. These auditing procedures are cumbersome and most companies dread the work involved. These determine the success of launching a CAPA system in an organization. The FDA has its unique Quality Inspection Technique (QSIT) that usually dictates that the inspection of a quality system in an organization can only commence after the management representatives in the particular areas under investigation have been identified. In addition the procedures that determine the situations under study are all laid down before the study. The FDA team can then measure the procedures against optimal set standards. The organization under study is then left with the task of ensuring that they can produce the necessary documentation to prove that those procedures are being implemented in the running of the organization.

ISO 1900: 2000 refers to the fact that a company undertakes the auditing process to be a measure of their willingness to commit to the policy statement that is a crucial undertaking for them to be certified.

Statement of the Problem

Majority of the companies that take up the CAPA system do so as a requirement for ISO and FDA certification. They do not take any seriousness in the implementation and application of the CAPA program. This in turn translates to ineffective CAPA implementation and ultimately negative results for the company. In a running company there has to be huddles in every level of operation. These are widely encountered by either the company’s employees or the customers who use the product or service. If the company intends on retaining and adding their customer base while ensuring that they produce quality products there is need to focus on identifying solutions to these problems and learning from them. This ensures that in future such problems and the conditions leading to them are averted and more effort is put on maintaining a competitive edge and not solving recurring problems. These organizations experience a myriad of problems in their day to day running and a lot of effort and resources is geared towards solving recurring problems. A CAPA system when correctly implemented is at times not given the right time to take root and companies despair to its function before its impact is felt.

This study will address these problems by seeking to find out the importance of the CAPA system in investigating problems and lowering costs for the organization to ensure a wider applicability of the CAPA program in all companies.

Purpose of the Study

In this study I will examine the importance of effectively implementing and managing a CAPA program and the consequences faced by companies that do not implement it in the right way. In this study I seek to investigate the implication of a well managed CAPA system to the company in terms of investigating and preventing the reoccurrence of problems and saving the company money.  This in turn will translate to an increased productivity for a company (Bossert

2004).

Theoretical Bases and Organization

When a Corrective and Preventive Action is implemented in manufacturing companies it is meant to increase productivity and reduce the cost of production. In addition it is supposed to increase customer satisfaction and also the profit of the company while still ensuring that the quality of the products is the best (Gale, 1995).

The management of a CAPA program in a company is a process that requires constant communication and application by all the integral parts of the organization. (King-Bailey, 2003).

For a quality inspection and the relevant certification of a company to take place the CAPA program has to be implemented as part of the internal auditing process. Its function to a company is in identifying and solving problem areas in a company. It checks the process of implementation of corrective mechanisms to ensure that recovery is constantly done before impending disasters interfere with the running of the company. The CAPA program depends on correct and precise planning for it to run as it is meant to. A CAPA system that is implemented in a hurry as a result of rash decisions will be incorrectly planned and the results will be dismal if not absolute failures. In this regard, there is critical need to ensure that the motive and the requirements of implementing the CAPA program are laid out as early as the planning stage of the CAPA implementation. In implementing the CAPA system it is important to get it done the right way and in the right duration to ensure that it is a success (Gale, 1995).

The relationship between the CAPA system and the quality system cannot be undermined. This translates to imply that by effectively managing and monitoring a CAPA system the company will in turn earn more profits. The most difficult requirement of an effective CAPA system is ensuring that all the employees in the organization participate in its implementation. This ensures that they are involved raising their motivation levels and also in ensuring an increment in their productivity. CAPA delves to utilize all the resources within the reach of the organization including its workforce by ensuring that their capabilities are utilized maximally for the benefit of the company. In this regard company growth will in turn translate to employee growth (Benson, 2007).

The first source of solutions for an organization should be in its workforce and CAPA ensures that the company seeks solutions from its employees fast.

ISO 9001:2000 Requirement for CAPA

The International Standards of Organizations SO 9001:2000 is designed primarily to guide organizations in establishing good quality management standards which will steer the organization towards all rounded growth.  It provides standardized requirements for all organizations to ensure their performance and financial improvements. An organization needs to work at meeting the needs of the customers. The ISO 9001: 2000 provides a guaranteed framework to ensure that all the products an organization manufactures satisfies the needs of a customer. The ISO basic framework assumes that the basic operations and the characteristics of all companies are the same. An advantage of this system is that it allows flexibility in the various approaches a company can use to meet its goals. In addition to auditing the quality based system to ensure accountability in the operating of the company, ISO also requires the company to invite the customers in order to involve them in determining the kind of products the company will produce and in ensuring that their needs are met at all times. In order to meet the ISO specifications the company may also ask for the opinion of an independent quality system certification body in order to be given the ISO 9001:2000 certificate of conformity.

The CAPA auditing process should be viewed not as a process to meet the government requirements but more so as a step that will enhance the organization as a whole. The ISO 9001: 2000 looks at the establishment of quality management systems in an organization, the correct application of these quality management measures that are specific to the company, a correct assessment and evaluation of the quality management systems and modifications of the quality management system with the intent of providing the best practices for the company. In each of the four practices CAPA is essential and fits in perfectly to ensure that only the best results are ensured. By targeting the processes before and after sales the CAPA system guarantees that the services and the products are constantly reviewed to suit the needs of the customers. This in turn will translate to an increased customer satisfaction, increased number of customers and in return an increased profit margin for the company. The ISO 9001:2000 emphasizes a continual analysis of data and eventual step by step improvement for each organization (Pesso, 1988).

Continuous improvement is critical for the company in order for the company to grow and then keep a competitive advantage over other similarly placed companies. The need for constant revisions is imperative to meet technology, standards, tastes and demand changes that are guaranteed to take place over time. Policies also change with term and a company therefore needs to constantly reinvent its operations in order to meet the changes and operate competitively in the global arena. Improvements can result only when a company regularly conducts and studies audit results, applies relevant corrective and preventive actions, and analysis their data. In addition to this the company needs to perform management reviews (Seaver, 2001).

All businesses are operated with the main focus being profit making. As a result of this focus a company’s focus should be in formulating and establishing systems that would ensure that all its operations are based on quality products. These will eventually translate to all the other positive factors for the company. When a company’s main focus is in ensuring the satisfaction of its customers nothing can go wrong. This is because the customers will dictate what measures the company will implement when producing its goods and services. The base line of companies operations is always customer satisfaction and this in turn heavily relies on the quality of the product that the company produces. ISO 9001 operates at developing and implementing systems that focus on gradual and continual improvement of the operation in a company. It focuses in enhancing optimal operations both in achieving better financial returns as well as in maximizing opportunities for growth for the company’s employees and employers. By working towards better employer and employee growth ISO 9001:2000 ensures that the workers are constantly motivated and they in turn feel valued as part of the company increasing their performance (Gale, 1995).

ISO 9001:2000 requires that the actions taken to correct a problem permanently be appropriate to its effects. Doing a thorough investigation is therefore critical to ensure that there is a logical match between cause and the effect (Godfrey, 2001).

What is Corrective and Preventive Action?

Preventive actions are actions that are designed and targeted towards eliminating causes of potential discrepancies in the running of a business organization. Corrective and Preventive

Actions inseparable fields when it comes to making quality management problems. They are formulated to improve the quality of products. This implies that they include manufacturing processes. They arise from a detailed postmortem of the problems in the company ad an even more detailed study of the solutions that can resolve the issue. They serve to identify the risk areas and the critical areas that a company can focus its resources to as opposed to the temporal solution factor. These prevent the company from wasting its time and resources by eliminating potential threats before actualization (Johnson, 1997).

Corrective actions on the other hand are the actions that are designed to terminate the cause of discrepancies in a business organization to prevent their recurrence.

Corrective and preventive action refers to the process of reacting to a problem caused by a certain product and addressing the issue effectively until customer satisfaction is ideal. In addition to reacting to the existing problem, the CAPA strategy involves the process of predicting the occurrence of potential problems and eliminating them.

The FDA and ISO certifications mandate that a company has to apply an active CAPA program as an integral component of a quality system. A well planned and implemented CAPA system is important as it leads to improved goods and services and results to better customer satisfaction. It leads to faster and better growth for the company.

Corrective and Preventive action programs are implemented through seven major and essential steps. It is mandatory that for proper implementation to occur there is constant documentation for each of the steps. This guides in the evaluation of the CAPA program.

There is need to identify the existing problem. This will include determining the specific source of the problem. The source of the problem is documented whether it is from the employees or the customers or even in risk analysis. Other sources of problems include internal quality audits and after monitoring processes that are implemented in the organization. In addition there is need to document the available evidence that show the existence of the problem. This helps in understanding the problem and also during the investigations that are done to assess the problem.

After identification it is necessary to evaluate the problem. This involves a complete assessment of the problem by determining who it is affecting and to what extent. It is necessary to document the potential impact of the problem and the related risk that is posed by the problem. This will determine the actions that will be taken to remedy the problem. After determining the risk an immediate action is taken before a permanent solution can be found which will assess the problem at hand (Johnson, 1997).

After the temporal remedy is actualized a thorough investigation is then conducted to research the problem. A written proposal of the investigation is created. This proposal includes the objectives of the investigation, the strategy that will be most effective in the investigation and an allocation of the responsibility and the financial budget required including all the resources that need o be allocated to the investigation (Benson, 2007).

A thorough analysis is then put in place to identify the possible causes of the problem. This includes correcting data on every possible cause and documenting it. The most critical step in this step is determining the root cause of the problem. The data collected is used to conduct the root cause analysis that requires one to find the sole root cause of the existing problem and deal with it as compared to dealing with the symptoms. This ensures that the root cause is addressed permanently and the problem is permanently resolved.

It is critical to then form an action plan that will address the problem using the best method possible. All the processes necessary to correct the problem and prevent a reoccurrence are then made into an action plan. These processes are laid out in an east to implement plan and the various responsibilities are assigned to individuals. The employees are then trained to ensure they are competent in addressing the causes and the solutions to the problems. This is essential so that they are able to understand the problem and avoid it in future. All changes and modifications to be made resulting from the problem must therefore be communicated to the employees to avoid a recurrence. The action plan that is formulated is then implemented and all the set tasks are accomplished. The actions that are implemented are documented (Godfrey, 2001).

After determining the necessary plan of action and implementation of the necessary tasks it is crucial to evaluate the processes that are implemented to determine their impact to resolving the issue. The assessment is also done to ensure that the identified tasks are verified and their efficiency and appropriateness is assessed. In the evaluation process it is imperative to document whether the set objectives are met and whether the solution was permanent in resolving the problem. When documenting the evaluation steps it is necessary to consider whether all the changes have been complemented and whether the necessary training of the employees and communication has taken place. The changes on the product and the services involved caused by these corrections must also be concerned to ensure that it has no adverse effects.

All the information of this process must be recorded and proof stored that all actions that were undertaken to solve the problem were completed successfully. After this verification, a validation of the process is done. This must document that the root cause of the process has been successfully solved and any resulting situation addressed with no recurrences. In addition to this proper controls have been implemented to prevent a recurrence of the same problem in future. These controls and the process actions must not affect production and quality of the products negatively. After all this is done a corrective and preventive program can be said to have been successfully implemented ad all that is now required is just its constant monitoring and upgrading.  The CAPA is then dated and signed appropriately.

Most business organizations have problems in differentiating between corrective and preventive action and may use the two tiered approach in their implementation. The problem with this however is when they fail to distinguish between the two types of action and end up messing the whole implementation.

The research conducted by the quality digest team on the effectiveness of CAPA system indicates that when ASQ automotive company implemented such a system they got a 3:1 return for all the internal and external costs they incurred and a 17:1 return on the registration costs they incurred that were out of pocket (Oliver,2008).

CHAPTER 2

REVIEW OF RELATED LITERATURE

The amount of published research from Corrective and Preventive Action studies are limitless. These describe the various definitions, benefits and the various recommendations that can be undertaken to ensure that the CAPA system being implemented in an organization fulfills the set out goals. The corrective and preventive actions are key areas of interest in the food and drug administration as well as in the International organization for Standardization.

If a Quality System is going to be effective in fulfilling its expected objectives, there is critical need to ensure that it is monitored closely and maintained optimally to provide continuous improvement to the System. This is the truest indication that indeed an organization is committed to improve the welfare of the organization and its not just looking at the audits for certification purposes (Gale, 1995).

In the QSIT auditing procedures Food and drug administration follows strict guidelines at what an organization is doing to correct and monitor a system. They ensure that the procedures taken are effective not only for ending the current problem but also for ensuring that there are no more recurrences of the same problem. All this is done while ensuring that the system and the product is not adversely affected by the measures and recommendation put in place.

Companies have a big problem when differentiating between the corrective actions and the preventive actions. The combination of the two procedures forms the dual CAPA system although at times this is the downfall of the whole system. If CAPA is taken as one step and the guidelines followed in a step by step protocol each being given equal significance then the system will kick off successfully. However if the companies do not understand the difference between the two procedures they perform no corrective and preventive actions because they end up jumbling the two and not performing either successfully.

It is imperative that during designing and implementing a CAPA system a company focuses on tailoring a solution that will be the best and the most practical to address the problem. Implementing a CAPA system is expensive requiring a business organization to devote a lot of its time and human resources. It also requires a lot of money and technological investment. To acquire the greatest returns for this investment companies need to use a top down approach to ensure that all their staff are involved in the CAPA process. There is also need to ensure that there is consistency in applying the strategies laid out by the CAPA. For real change to take place there is need to invest time so as to give all the employees the appropriate time to familiarize themselves with the change in protocol. CAPA strategies also need time to take root and change the functioning of the organization. Needless to say the real change does not take place overnight and time is required before the company can declare the CAPA system as useless. Consistency in the application of the corrective and preventive programs ensures that their quality is maintained from day to day (Basic, 2006).

Normally the management in companies finds no need to involve the staff in decision making and implementation. However developing and successfully implementing an effective CAPA program in a business organization requires a top to bottom approach. Many organizations fail in implementing CAPA solutions when there main focus is on the bottom staff and they leave out the top staff. These problems are tackled effectively when they are implemented departmentally to solve these problems at individual levels (Gale, 1995).

Solutions that are implemented from Bottom to up are not effective in achieving the most optimal operational efficiency because they rarely reach all the staff. Real change will only occur if the correctional and preventive measures blanket all the staff and each individual member of the organization fulfills their mandated task. The failure to break down responsibilities will result to a lack of accountability within the staff resulting to poorly implemented solutions.

The cost of poor quality system is enormous to a companys’ financial budget.  Experts have estimated that the cost of poor quality can take up from 5-30% of the companys total gross sales and may consume more than 20% of the company time. Needless to say this ends up taking millions of dollars not to mention the thousands of productive company time that the employees waste trying to recover mistakes that could have been avoided in the first time (Gale, 1995).

This loss is unnecessary and leaves companies existing on a need to survive basis. Instead of taking their time to formulate policies that will favor them in the market they end up making rushed decisions based on the policies that are formulated by their competitors. Even in companies that have not implemented CAPA systems the fact that quality is mandatory to success in business is not debatable.  However when they see how much work goes into ensuring quality systems and the methodology of achieving these goals are varied with some opting for the easiest strategies. It is absolutely essential that an organizations policy on quality be formulated in such a way that it provides the guidelines that are necessary for correcting the specific quality objectives (Gale, 1995).

ISO 9001:2000 requires that an organization’s quality policy provide a framework that will constantly review a companys quality objective. These policies should give the way forward when it comes to fulfilling the set objectives and should highlight the direction that the company should take in fulfilling the mandates.

A Snapshot of ISO 9001:2000 Requirements

Requirements

Description of Requirement

Training, awareness and competence.

A company should be sure that the employees receive proper training, are aware of QMS requirements and are capable of carrying out their quality management responsibilities.

Communication

The whole CAPA system depends on the ability of the company to establish and maintain proper communication to enhance management issues.

QMS documentation

Documentation allows proper and comprehensive audits. All the processes should be documented effectively.

Document control

The companys operating quality management system procedure should all be documented.

Operational control

Readiness for all your operations and activities to correlate with your quality policy, objective and targets. Plan, manage and have control of all factors.

Emergency preparedness and response

Be ready for potential emergencies, anticipate and develop procedures for preventing and responding to them.

Monitoring and measurement.

All measures need to be quantified. Have the necessary monitors on key activities to check performance. Check compliance periodically.

Nonconformance and corrective/preventive action

Identify, prevent and address problems effectively to prevent reoccurrence.

Records

Keep adequate records of your QMS and its performance.

QMS audits

Conduct audits periodically to verify that your QMS is operating as it was intended to.

Management review

Review the QMS periodically and be flexible to allow continual improvement of the system.

Quality policy

Have a breakdown on your companys policy and apply it for subsequent planning an.............