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.

Literature review on SQL

Companies are involved in different operations that result in the generation of information. The information is never discarded rather it should be kept for the future references. The question to ask is how to keep the data. The database concept came previously with the usage of the file database until we came to settle on the sequential databases. The primary databases are the SQL databases and the Oracle databases that do perform the same job but with the application of different principles in the implementation of the functionalities. A database is described as the collection of related data that is organized and stored at a collective place for easily accessing, management and administration of the data.

History of databases and SQL
Database came in to ensure that the data stored can be retrieved or shared amongst the users without the know that there is sharing. In 1970, Dr. Codd published a paper “A Relational Model of Data for Large Shared Data Banks” that was the building block of the relational database system. He described a new structure for data within the database that brought the relational database system that is still in use up to current (Sumathi & Esakkirajan, 2007). On the other side, Chamberlin and Boyce (employees at IBM Corporation, Inc) developed a query language they referred to as Specifying Queries As Relational Expressions (SQUARE). The language did apply the set theory a predicate mathematics to have the select of data from the database. SQUARE acted as the building block for another language (Instructional Software Research and Development Group., 2006).

In 1974, Chamberlin and Boyce refined the SQUARE language to publish the Structured English Query Language (SEQUEL). The refinement focused on the data retrieval from the database, and they had taken the focus to applying the top-down programming that required the linear notation, and readable programs which are easy to modify and maintain. The result of the implemented got the description of the SEQUEL as structured (Chamberlin & Boyce, 1974). In 1979, SQL got into its existence by dropping the vowels EUE, the SEQUEL was found out to be a registered mark trade for Hawker Siddeley Aircraft Company that forced IBM to change the SEQUEL to SQL.

SQL Architectural framework
The architecture of Pl/SQL describes its working with the Oracle. The PL/SQL block is made up procedural and SQL statements as it describes how the SQL in Oracle interprets the PL/SQL block. The PL/SQL architecture contains the block, engine, and the Oracle server. The engine is concerned with the compiling and executing the SQL block, and the PL/SQL engine contains the PL/SQL procedural statement executor that executes the procedural statements. On the other side, the Oracle server contains the SQL statement executor that executes the SQL statement (Rosenzweig & Silvestrova, 2004). Therefore, the PL/SQL engine is in coordination with the Oracle Server for purposes of processing the block.

According to Instructional Software Research and Development Group (2006), SQL statements can be classified either;

Data Definition Language (DDL)
Data Manipulation Language (DML)
Data Query Language (DQL)
Data Control Language (DCL)
Data Administration Statements (DAS)
Transaction Control Statements (TCS)
Features of SQL

Structured Query Language (SQL) has got developed and meets the ANSI and the ISO standards as a computer language that can use in creation and manipulation of hierarchical databases. SQL has the capability of allowing the proficient user to undertake some administration activities such as create some views, update, delete records and retrieve the data from the database. It is very simple and easy for one to learn because it is sequential and structured in nature and it is to work with some other desirable database programs such as MS Access, and Sybase (Groff & Weinberg, n.d).

SQL database, the SQL Server 2005 and SQL Server 2008, have the data mining architecture that enabled the models to enhance business intelligence. Business intelligence components can easily get integrated into SQL server that includes the On-line analytical processing (OLAP), SQL Server Integration Services (SSIS) and the reporting services (Crat, Tang & MacLennan, 2013). SQL has been on developed and currently exhibit some attractive, unique features of supporting character sets, collations, and translations. A transaction can roll back on save points. The database language supports Boolean data type and large objects of binary and the character LOBs (Kreines, 2000).

Benefits of SQL
SQL does not require navigational instructions as it is coded without embedded data that simplifies the retrieval of data.
The applications applying the SQL are portable as well as the language gives a high level of abstraction, and its internal implementation makes it independent.
SQL is simple to learn and easily handle complex situations at the same time the language has no ambiguity about the way a query interprets the data.
The SQL is used in definition of the data structure; control the accessibility of data, delete, insertion and modification of data
Proposal

Iteration 1: Orientation
The orientation program captured my attention by familiarizing me to a few identities. I first had to sign the internship acceptance form from the Human Resource department after which I am to be directed to my designated department. Within the working point, I will introduce myself to the work mates and move around to have the familiarization of the company strategic location. I will visit the specified departments starting with the operational section from where I will have to understand the company core business operations, procedures, principles and the goals to achieve. The working conditions will also be provided to avoid the misrepresentation at working point.

Iteration 2: Understanding the SQL concepts
After the understanding of the company operations and my expectations, I will take some critical time to have the deep understanding of the SQL concepts. Databases go by experience and understanding of what the requirements are according to the company procedures. During the iteration, I will make some consultation from my working mates so that I take to know where I need to take the concentration of understanding. Secondly, I will undertake some online research to have the deep experience of coding and the most critical operations of the SQL. The model accordance to the Model will be under study. The personal studying will further involve the data analytics and the understanding of the big data. The iteration will be the preparation for the training that I will be taken through by the assigned supervisor. At the end of the iteration, I would have sharpened my knowledge and have the best theoretical understanding of SQL as far as the database is concerned.

Iteration 3: Training
The training will go through the application of the SQL and the implementation of the Oracle databases. The training will be conducted primarily to have the clear, practical understanding of the Oracle database and the SQL database. Define the principles of the application modes of the databases. The training will be conducted through the labs of the company where normal staff training and seminars take place. The process will be the preparation of the primary object of designing a database exercising gall the database administration and maintenance. Therefore, by the end of the training session, I would have gained the practical skills and experience of database administration.

Iteration 4: SQL Database designing
The iteration will get me through the steps prior designing and development of a database. First, I will have to undertake some feasibility so that I may be able to define the requirements of the company and the end users to be adhered to during the SQL database development. After then the designing of the application will take its course by applying primarily all the knowledge of SQL database to have the database that meets the determined requirements after that the last iteration will follow.

Iteration 5: SQL database administration and management

The iteration is the other critical activity that I will be involved. The primary expectations are ensuring that the database is up to date the demands of the end users are accomplished. During the process I will be updating the database, deleting some entries. Furthermore, create the views procedures and the queries as well as reports and more so enhance the security within the database. Actually, at the end of it all, I would have got the best knowledge than ever that will get me into the market with the desirable experience and skills.