Five Crucial Skills That Each and Every GMP Internal Auditor Must Have

Conformance with GMP (Good Manufacturing Practices) is still crucial to ensuring the security and quality of pharmaceutical products, even as the business grows and changes. Thus, to ensure compliance with industry standards, GMP is crucial to all pharmaceutical manufacturing processes. Establishing and carrying out an internal audit process is one of the most important measures to meet those standards. To make sure that GMP processes are correctly followed throughout the company, an internal audit team made up of one or more GMP internal auditors is essential.

Which Top Skills Are Needed for GMP Internal Auditors?

In the biotechnology, pharmaceutical, and medical device sectors, Good Manufacturing Practices (GMP) refer to a system of rules and regulations that guarantee the consistency, quality, and safety of products. Tracing issues, confirming compliance, and streamlining procedures all depend on GMP records and documentation. Quality assurance specialists, inspectors, and consultants who need to confirm the veracity, correctness, and completeness of the information must possess the crucial ability to audit GMP documents and records. We’ll look at the abilities required in this post to successfully and efficiently audit GMP records and documentation.

Interpersonal Skills: A successful auditor must possess effective interpersonal skills, such as active listening. 80% of the time should be spent listening and 20% should be spent talking, according to the “80/20 rule”. Since they have to share their opinions, ideas, and proposals with other auditors, executives, senior management, and regulatory bodies, auditors place a high value on communication. Misunderstandings, useless advice, and a loss of trust can result from poor communication. Attend the online GMP auditor training, workshops, or seminars to hone your communication abilities. You can also concentrate on your active listening skills. Almost as important as technology skills, communication skills rank as one of the top two attributes auditors should have.
Know the GMP Requirements: Understanding the pertinent GMP regulations for one’s product, process, and market is essential for conducting an audit of GMP documentation and records. The kind of product, level of complexity, stage of development, and regulatory body may all affect these needs. Understanding relevant GMP standards, guidelines, and regulations from organizations like the ICH, EU, FDA, and WHO is essential. It’s also crucial to interpret and utilize these recommendations in the context and circumstances that are unique to you.
Planning, Multitasking, and Time Management: Since auditing entails organizing the day or days and scheduling procedures to be audited, it is crucial for auditors. Time management is essential to ensuring that activities are prioritized, as smaller businesses frequently create internal audit teams from within their current workforce. Tight timelines for audit completion are necessary, and ineffective time management can result in hurried or incomplete audits, overlooked compliance problems, and postponed corrective action. A thorough audit plan, early deadline setting, and work prioritization using calendars, to-do lists, task management applications, reminders, and audit management software are all effective ways for auditors to enhance their time management abilities. By concentrating on these elements, auditors may guarantee that the audit is finished on schedule and prevent oversights of compliance problems.
Communication Skills: A variety of stakeholders, including the auditee, the auditor, management, regulators, and customers, must be communicated with when conducting an audit of GMP documents and records. Communication with all parties involved must be done in an understandable, professional, and courteous manner. Engaging in active listening, posing pertinent queries, offering helpful criticism, and summarizing your conclusions and suggestions are all necessary. Depending on the audit’s goal, audience, and circumstances, you should be able to modify your communication style and tactics.
Professional Scepticism: To be a trustworthy, moral, and productive auditor, one must possess professional scepticism. Avoiding quick cuts and reassessing every step of the audit process is part of it. This mindset entails remaining impartial, doubting the veracity of information or documents, and approaching evidence with scepticism. Between total trust and total doubt, there is a balance. Using a sound judgment process, taking into account all pertinent facts, being receptive to new ideas, and avoiding biases and judgment traps are all important ways for auditors to develop their professional scepticism. They become an ethical, successful, and trustworthy auditor with this method.

Tenet Healthcare.

The Healthcare Financing Administration notes the annual health care expenditure in the United State has exceeded $ 3.1 trillion. 10% of these expenditures ($ 100 billion) are government and health insurance companies losses due to fraudulent healthcare transactions. Timely detections and prevention of these fraudulent transactions and abuses can help recover the huge amount of resources to medical institutions and patients thus improving the quality of care and decreasing the cost of healthcare for taxpayers. Inability to detect fraud can become an extremely costly, painful and damaging problem to the organization and thus the need for an effective fraud detection system (Mcmahon & Chopra, 2013). In 2012, Tenet health Corporation was ordered to pay the United States F$ 42.75 million to settle accusations of violating the False Claims Act by overbilling the federal Medicare Program (Department of Justice, 2012). This action research will discuss how healthcare billings happen in the United States and will give details of the fraudulent billing occurring in Tenet Healthcare Corporation. I will show the impact of this fraudulent billing to the stock prices and financial statements of Tenet, showing that they directly impact the shareholders finances having their stocks at Tenet

Tenet Health Corporation (Tenet) is an investor-owned health care services corporation. Tenet Health corporation operates 77 acute care hospitals, 173 outpatient centres, 5 health plans and 6 accountable care organizations. In addition, the corporation operates Conifer Health Solutions that provides health business process solutions in fifteen centres that serve clients in 43 states.

The study will help Tenet develop a fraud detection system that will sufficiently address it billing process to avoid future billing errors that will ruin the reputation of the company and destroy its financial base. In addition, the study will offer insight to other health care institutions on factors that precipitate fraudulent cases in institutions and the financial implications of the fraudulent case.

The study will be based on the Cressey Fraud Triangle. Three components of the triangle include pressure, opportunity and rationalization. Pressure relates to the financial difficulties such as a large amount of credit card debt, overwhelming financial burdens, and financial difficulties. Opportunity to fraud exists when an employee discovers a weakness in the organization’s ant-fraud controls. Rationalization is the psychological process whereby individuals who have committed fraud convince themselves either that the act is not wrong or that even though it may be wrong, it will be corrected because they will eventually return the money. In addition, employees may justify the fraud by taking the attitude that they deserve the stolen money (Goldman, 2009)

A comprehensive detection and prevention system should have the right combination of financial analysis, business/relationship analysis, medical insight and analysis, detection of changing behaviours and a feedback loop (Abbasi, Albrecht, Vance, & Hansen, 2012). Therefore, the study will primarily focus on evaluating the effectiveness of this component in Tenet. In addition, the study will focus on analyzing the effect of the fraudulent on the stock prices and financial performance of the Tenet. The study will focus on the financial statement fraud and the stock prices of the company during the time the fraud occurred. Financial statement fraud is mainly dedicated to the fact that financial statement audit ensures that the financial reports of the company are free from material misstatement and fraud. A firms’ propensity to commit a fraud depends on the expected benefits and cost of engaging in the fraudulent. The expected cost of the fraudulent has two components that include the probability of the fraud detection and the penalty upon detection.

The financial statements of Tenet will be evaluated to identify the misstatement and the impact of those misstatements, the investment trend of the company and the stock prices of the Company stock. The data will be obtained from the annual reports including Form 10 K and other strategic documents. The reports will be analyzed through various econometric models to evaluate how the fraud case affected their trend. A five year period analysis will be conducted. In addition to the financial econometric analysis of the financial reports, a detailed key informant interview will be conducted with stockholders of the company who will be selected randomly. The interviews will be conducted through open-ended questions to allow the respondents to disclose as much information as possible. The interviews will substantial the findings of the analysis. The findings of the study will be corresponded to Tenet Corporation in the form of a report. In addition, the result will be published and disseminated to online databases to benefit other scholars and organizations.

The research will be conducted with the authority and supervision of the University Committee. In addition, consent will sort with the Tenet Corporation. The current CEO and the chief finance officer will be contacted advance to approve the research. Some of the key ethical issues to be addressed in the research is the confidentially of any confidential information accessed during the research and limiting the finding of the study to academic use. The key limitations of the study are its reliance on the documented reports. The study will not allow the research to evaluate the raw financial data of the company but will rely on data from SEC listing and other stock sites such as NYSE.

Bottle Water vs.Tap Water

Introduction
The fact that it is critical to keep the body extremely hydrated at all times goes without any debate. However, which is the best water to consume? Traditionally, tap water had been the norm in many offices, homes, and schools. However, bottled water has become popular with the increased notion that the water is purer and cleaner than tap water. On the other hand, bottle water can be contaminated thus leaving tap water as the best alternative. The decision to consume tap or bottled water is a personal choice that is supported by numerous factors. Tap water is, however, a better alternative than bottled water as even most of the bottled water are collected from taps and not springs or glaciers.

Body

People with a preference for bottled water believe that the water is purer than tap water. Water manufacturing companies have been able to convince their consumers that their water is collected from pure an unpolluted areas such as spring water and glaciers. Therefore, water from the glaciers and springs is purer than tap water since tap water has to pass through underground pipes and systems thus increasing the risk of contamination (Brebbia, 2015). For instance, the risk of having traces of lead in tap water increases if the water system has aging pipes. Unfortunately, the perception of pure and unpolluted water cannot be validated as unscrupulous water manufacturers can also label and packaged tap water and deceive consumers that the water is pure.

The preference for bottled water over tap water also arises due to the taste. A majority of people who consume bottled water argue that the water tastes better than tap water. Bottled water passes through a series of purification processes thus the minimal risk of experiencing tastes and odors. In contrast, tap water is in an almost natural form thus the risk of experiencing an “earthy” taste. Moreover, there is a risk of rusting of the water pipes thus increasing the occurrence of a “taste” in the water. Bottled water is processed and tested before it is released to the consumers. A guarantee of quality is therefore assured.

The preference for bottled over tap water has also been due to concerns over the safety of the tapped water. A majority of community water systems fail to meet the standards of the safe drinking water Act thus increased the risk of exposure to unsafe water. Moreover, there are concerns that tap water may be more at risk of exposure to germs than bottled water. Water running from taps comes through an underground water system thus the risk of contamination especially in the case of breakages (Gleick, 2010).

On the other hand, proponents of tap water argue that bottled water is an unnecessary expense. Water is a basic necessity for survival thus there is no need for the commodity to be expensive and unaffordable to many consumers. The cost of bottled water is high as the manufacturers have to factor in production and transportation costs. Some manufacturers also strive to make quick profits thus over price their bottled water. In contrast, the cost of tap water is quite low thus making the crucial commodity affordable and accessible to everyone.

Tap water is also a better alternative to bottled water because it has the least negative impact. For bottled water, the manufacturers have to mass produce bottles. Therefore, millions of plastic bottles are then released to the consumers. Without a proper recycling system, the millions of plastic bottles end up as non-biodegradable waste which subsequently increases pollution. Moreover, the production of the plastic bottled also involves the burning of oil which results in the emission of carbon dioxide that in turn affects the ecological system. Water bottles are made from polyethylene terephthalate (PET) that releases toxic chemicals including ethylene oxide and benzene (Vesilind, & DiStefano, 2006). In contrast, tap water does not pollute the environment since the water is available directly from the taps and faucets.

Personally, I know tap water is a better option that bottled water. The fact that water is from a bottle does not make it safer. The bottled water could have fetched at a tap and sealed as bottled water thus exposing the drinker to a higher risk of contamination than tap water. Tap water is monitored and regulated for contamination thus ensuring minimal risk to drinkers. The water is also readily available to all and thus can be provided in schools in limitless and affordable supplies. In contrast, bottled water is unnecessarily expensive, yet tap water is just a fraction of that cost (Mackey, & Boulos, 2004). It is true that there are concerns over the quality of tap water and the risk of contamination. However, tap water can be monitored and tested regularly to ensure they are up to the expected standards.

Conclusion

Water is an essential health commodity that is critical for survival. The question of whether to consume bottled or tap water lies on factors related to the risk of contamination, the cost of the water and the sustainability of the water. Bottled water manufacturers promise their consumers that their bottled water is from springs and or glaciers thus it is bottled at its purest form. The reality, however, is that most bottled water comes from tap water; thus manufacturers dupe consumers with false advertisements. Bottled water is also unnecessarily expensive, yet tap water is affordable and accessible to many. Tap water also guarantees the sustainability of the environment as the production of the water does not undergo numerous process. In contrast, bottled water results to millions of plastic bottles that are non-degradable and choke the environment.