Essential Elements of a Quality Management System

A good quality management system in a pharmaceutical company can significantly improve the net profit status, high quality medicines for patients, less rework and recall which save more money, good work environment and compliance with local and international regulations.

Quality management is a philosophy. It takes management understanding, commitment and responsibility before introducing and implementing the concept. Once practiced a good quality management system slowly develop or reshape a sustainable organization culture that pays off rapidly.

The initial step of introducing a good quality management into a system is to know the essential elements of the quality system and clear study from where to start. Company objectives should be clearly understood. Policies should be prepared. Then comes the design of the process flow, validating the process, material flow and organization chart. When a good integration between people, process and material is achieved the next step is to putting the integrated system in a state of control. Any deviation from the controlled system must be analysed and corrected.

Some basic but essential elements of Quality Assurance as depicted in GMP guidelines and ISO 9001 guideline for pharmaceutical industry can be listed as: the Preparation of standard operating procedures of a complete system maintaining cGMP principles; Preparation and maintenance of effective change control of quality and master file documentation; Recording and management of manufacturing change control; Recording and reporting procedure of Deviations of your systems; Quality concern investigation process; Customer complaint investigation procedure; Quality audit procedures; Vendor assessment, evaluation and certification procedure; Quality control laboratory procedure, Rework procedures for the defective manufactured products; Procedures on training for manufacturing staffs and recall procedure.

Standard operating procedures and manuals should be written in details and referenced to relevant other documents, so a new starter within the organization should be trained easily and expected to perform as per procedure. The result will be a common standard of activities across the organization, good tractability of work flow, deviations and ease of corrective actions as necessary.

Standard Operating Procedure

You should prepare SOPs, forms, templates and manuals, which can be used immediately as the system runs. Forms and templates should be used for record keeping which your people can follow routinely.

Documentations – Classification, Definition and Approval

Quality and Technical/Master file documents to be created to build up a good quality management system for your manufacturing sites. Definition of documents, their classification, approval requirements and retention requirements should be understood.

Quality Documentation Management and Change Control

Procedures to be created on how to generate new quality documents or change control of existing documents, review of quality documents, satellite file management, role of document author, approver, document control officer and satellite file administrator. In this procedures you will also define the numbering systems of different quality documents like audit files, SOPs, forms, templates, manuals, training files, QA agreements, project files etc and their effective archiving system.

Preparation, Maintenance and Change Control of Master Documents

Procedures to be created which will particularly focus on the management of master file documents like specifications, control methods, raw materials, finished goods and packaging specification and test reports, formulation, stability files etc required to generate during the product registration in the market.

Deviation Report System

It is a regulatory requirement to capture all sorts of deviations evolves in your systems in order to maintain the continuous improvement of your processes and systems. Procedures should be created that describes how to categorize the deviations between production, audit, quality improvements, technical deviations, customer complaints and environmental, health and safety deviations. It should also describes the management responsibilities of initiating deviation, capturing data, analysis, investigation, determination of assignable cause/s, generation of management report and initiatives to be taken on corrective and preventative actions.

Vendor Selection and Evaluation

Procedures to be followed during the vendor assessment and vendor evaluation for purchasing of raw materials, critical and non critical packaging components, laboratory supplies, engineering supplies and imported finished goods from the vendor. These instructions are essential for approving prospective vendor.

Vendor Certification

This procedure aims to describe the process by which a vendor may be certified to supply materials or services. This procedure applies to vendors that supply a material or service to be used at any stage of manufacture by operations. Here you will describe the roles of each department in the process to certify an approved vendor.

Product Complaint Procedure

You should have strong procedure to cover the receipt, logging, evaluation, investigation and reporting system of all complaints received from customers for the marketed products. This procedure should contain step by step instruction to be followed during the customer complaint management like numbering of complaint, registering the complaint, evaluation, determination of assignable cause for the complaint deviation, implementation of corrective and preventative actions, trending of complaints and handling of counterfeit products.

Annual Product Review

Some countries require reports as Annual Product Review to sell your products into their market. So you have to create instructions on how to do annual product review, to evaluate data, trends and to identify any preventative or corrective action that would lead to product quality improvements and report them to management.

Rework Procedure

Procedure should contain the step by step instructions to be followed when the rework of an in-process or completed finished good is required. Product Identification and Traceability The purpose of this procedure is to define the method used for the identification of all contributing materials that could affect product quality and to ensure their full traceability.

GMP Audits

Procedure should be created to describe the process of planning, performing, reporting and follow-up of different audits for your systems like Internal Quality audit, Vendor audit, Environmental Health and Safety (EHS) audit, EHS workplace inspection, Housekeeping audit.

Evaluation of Batch Documentation and Release for Sale

This procedure should describe the process of collection, evaluation and record of batch related document generated during the production of a batch before an authorized person can release the batch for sale.

GMP Training

Effective GMP related training modules to be created for your manufacturing staffs. Training records and reports have to produce on each employee as justified.

Management and Control of Contract Work

There should have procedure to describe the management and control of contract work provided by the contractors for packaging and finished products for your company as well as control of contract works done by your company on behalf of others.

Quality Concern Investigation Process

Procedure should be made that contains instructions to follow when conducting Investigations collection of data and information, analysis, assigning root cause, determine corrective and preventive actions.

Medical Assistant 101 – Duties And Responsibilities of Medical Assistants

Curious about what Medical Assisting is? Well, it is one of the fastest growing careers nowdays. Experts say that this job will be the most promising for the next ten years because of the technological advancement in the medical field and the increased number of people in need of medical treatments.

Becoming a medical assistant is very easy for it only requires a high school diploma or a GED equivalent and there is no formal education or training requirements needed unlike other career such as nursing. Aspiring MA must only undergo programs which will only take six months to two years to complete.

Program courses include medical terminology, anatomy, and physiology. Students are also taught to have the knowledge on keyboarding, recordkeeping, accounting, insurance processing and transcription. Moreover, students learn some laboratory techniques, pharmaceutical principles, clinical procedures as well as diagnostic procedures.

Program courses are specifically designed to give them a broad perspective in medical field to help them perform their task efficiently and effectively. This is because their nature of work is to perform or to keep medical establishments organized and to keep it running smoothly. Moreover, since they will always interact in almost all people in the hospitals even with the patients, their program courses also include patient relations, ethics and medical laws.

Medical assistant is different from a physician assistant or a nurse. Physician assistants perform medicine or treat patients with the supervision of doctors while MAs are to perform both clinical and clerical tasks.

Generally a medical assistant handles administrative duties and or clinical duties.

1. Administrative Duties and Responsibilities

– Answering telephone calls
– Greet and assist patients
– Appointment scheduling
– Do patient's billing
– Bookkeeping
– Handling correspondence
– Filing and updating patient's medical records
– Handles insurance forms
– Arranging hospital admissions
– Assisting in laboratory services

2. Clinical Duties and Responsibilities
– Taking patient's medical history
– Recording patient's vital signs
– Preparing patients for medical examinations
– Assisting doctors during medical examinations
– Explaining to patients the procedures
– Collects and prepares the laboratory specimens
– Purchasing medical supplies and equipment
– Disposing of contaminated medical supplies
– Preparing medical instruments
– Making sure that hospital rooms such as waiting rooms and examination rooms are clean and tidy

In some hospitals medical assistants are allowed, under the supervision of doctors to perform basic medical tasks such as:
– Basic laboratory tests
– Prepare medicines and administrator medications
– Instructing patients in taking medications and some diets
– Drug refills
– Draw blood
– Changing of dressings
– Removing sutures

With these large scope of duties and responsibilities, medical assistants should be well-organized and can do multi-tasking at the same time. They must also have pleasant personality and must be good communicators for they must make the patients feel comfortable and at ease before and or during examination. Moreover, they must be neat and well groomed for they should look presentable when dealing with patients.

Duties and responsibilities of medical assistants vary depending on the hospitals they work. In small hospitals or clinics that are to perform both administrative and clinical duties while in large hospitals where there are other medical staff, they are encouraged to perform specific tasks under the supervision of the department administrators.

Regardless where medical assistants work, they are very useful in helping other healthcare workers to perform their jobs more effectively and efficiently. As a result, the increased needs of people's medical attention are met through them.

What Are the Advantages of Using a Web Based Project Management System

Every project needs a large number of people for the completion of any task. Projects are of several kinds, and there capacity level is also variant. In order to help the managers control all tasks, management system was introduced. Project management system is used to make the managers feel easy. The first type of a project management system is manual.

However, nowadays much web-based project management software is available in the market. There is no need to process data manually. Everything is computerized; managers just have to enter the basic information into the system. Nowadays, lots of project managers are opting for web-based project management systems. They have access to the web-based project management software’s, and tools.

Using a web-based management system has several benefits. Project managers can reach their computers from anywhere, not only computers, but they can also contact their team members and check the progress of work. Discussing any problems that arise with the team is a lot easier. Team members can also interact with each other via e-mail.

Project scheduling is the basic solution of web-based task management plan in a large organisation. In many ways a web-based activity management plan can help your managers achieve optimum results. Whether a project is based on finance, marketing, construction, or information technology (IT), and web-based project management plan can help t.

Web-based activity management plan helps managers to make a proper scheduling plan of the project. Web-based software has many tools which help in managing time, and activities. The software includes spreadsheets, network diagrams, or Gantt charts to control the task management scheme.

In project-management scheme, HTML, ASP, or PHP are the supported languages coded into the software, and browser. The team can access it through a web browser. Moreover, main software is installed on to the server for multiple clients.

Project management scheme helps managers to supervise all the team easily. If the manager finds any team member late in the completion of the task, he/she can track the problem, and change that member, thus, avoiding any delays.. Web-based project-management-system enables the mangers to distribute the workload according to the capability of human resource (HR). In addition, he/she can monitor the performance of each person involved in the completion of a job. This web-based project management system also enables the manager to measure the achievement, and performance of the team in accordance to the strategy chalked down for completion, or achievement of the target.

Web-based project-management system keeps the human resources satisfied from the point of view that whatever performance he/she is given is being registered, and is not over looked. If, a company is using a custom-made programme, which is flexible to different projects, it remains cost effective, and is not a burden on the bottom line. For different projects, which have different dynamics, companies may need a tailor-made programme for them, This can be a little costly, but it ensures better management, proper monitoring, and timely completion of tasks, ultimately ensuring good performances. Nowadays, this web-based project software is a very important tool for the management of any project. Furthermore, using the correct project management scheme, and software, can help managers to manage their project smoothly, and effectively.

Can Someone Find Me With Just My Phone Number?

Due to the fact that there are so many different online reverse phone lookup sites, and they have become very popular for tracing the owner of a phone number, you may be worried that your phone number may provide anyone who cares to use it with your personal information, such as your name and address. However, before you become overly concerned, you should know that the type of information that will be divulged to someone searching your phone number will likely be very vague.

What you need to understand is that how much information a person can find on you using your phone number depends on the phone number they are searching. For instance, if you have a listed landline number, a person who conducts a reverse phone lookup on this number will likely be provided with your name (typically last name and first name initial), address and location.

This should not come as a surprise to you, especially since this information would also be included in your local white pages. Your wire line phone number typically becomes part of the public phone directory, unless you personally request to have your phone number unlisted and removed from the directory.

Your cell phone number, on the other hand, is an entirely different story. If your cellular number is searched, the person conducting the search will not be provided with any real information that will be useful in finding you. The reason is because, the only clue they provided in relation to your whereabouts is your location. The state and city where you stay or are near will always be provided because this information is linked to the area code of the number. However, keep in mind that if someone is determined to trace you through your cell phone, they can pay for a more detailed search which may reveal your name and address.

What can you do to prevent people from finding you with your phone number? The following are two suggestions:

– Block your phone number, especially when calling people you do not know or trust, so that the Caller ID will not register who is calling. To block your number, dial * 67 before entering in the phone number you are calling.

– If you need to give a new acquaintance your number give your cellular number instead of your landline number because the cell phone is harder to trace back to you.

Finally, if you are very concerned about what personal information is made available to the public public, you should trace a cell phone number that belongs to a friend, or trace your own number to find out what type of information is provided.