Continual Improvement and Continuous Improvement - ISO, NABH, Quality

Continual Improvement and Continuous Improvement ISO NABH Quality

Topics covered in this video:-

1. Continual Improvement
2. Continuous Improvement
3. Key Performance Indicators

Potential of Quality Approach

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INTRODUCTION

In this short article, I have given my views on Quality Approach, you may or may not agree with me completely... but even then, please read on...

BASIS OF QUALITY APPROACH

In the above image, I have summarised the basis of Quality Approach

Adopting quality into your business means striving towards business excellence

The three paths that leads to business excellence are:

Excellent process design

Excellent product design

Excellent service design

These three activities are carried out with focus on the final result - the aim of a business is "business sustainability"

QUALITY BEGINS WITH HUMAN BEINGS

I have always maintained that Quality is man made and the mankind has the power to either build or destroy through various activities which are either beneficial or harmful. To quote myself “Quality begins with human beings”

Both in the service and the manufacturing industries, we are always talking about business excellence - this is achieved only through an excellent Quality Approach

QUALITY APPROACH - A TOOL FOR GROWTH AND DEVELOPMENT

Most important is realising the potential of Quality Approach as a vital tool for overall development of an excellent business process, which creates both good customer base and good profit margin for the business. Second most important factor is incorporating this into the training modules of the organizations - training is the ultimate mode for creating a knowledge base

Knowledge is power, it creates growth of the human mind, and once this is achieved, adopting a Quality Approach becomes easy. Such awareness instils enthusiasm and willingness among employees at every level of the organization to contribute to quality enhancement. The feeling of process ownership is created, leading to the feeling of responsibility towards the final result of the process. Obviously, this feeling leads to the desire to keep on improving, in other words, continual quality improvement

This type of a learning environment leads an organization towards a fruitful journey on the path of Quality, which is possible only through Quality Approach. Once a good Quality Management System (QMS) is established in the organization, then Quality Approach enables the employees at all level to maintain and sustain the QMS successfully. ISO-9001 is the base for building such a structure - Quality Approach is synonymous with Process Approach

Quality Approach is all pervading and is an integral part of process design, product design, service design, business sustainability (profit structure). Quality Approach also plays an important part in structuring behaviour towards the customers - both internal and external. All these factors interact with each other to create Quality, which as we all know, means satisfying customer requirements and enhancing that satisfaction

A very important potential of adopting a good Quality Approach is that it enables the organization to build a good competency matrix and thereby hire appropriately skilled and experienced staff, especially so because the service sectors and manufacturing sectors need very highly skilled personnel to execute their tasks with perfection

THE FLIP SIDE OF QUALITY APPROACH

Is the unwillingness of certain organizations to adopt it. There are instances when there is no actual growth in quality within the organization; the organization just wants ISO certification to gain business advantage. Within some organizations, there is a lack of comprehension of the true implications of quality as a tool for improvement of the processes, thereby upgrading the product or service delivery standard

All said and done, it is important to note that because quality is a human activity, therefore there are bound to be limitations - one of the greatest limitations is “error”; nothing can be free from error though we strive towards “zero defect”. There will be human related limitations in process design, product design, and service design. In spite of this human limitation, Quality Approach gives us the confidence in our abilities to provide products and services which are free from errors

                                      

Differences Between DAMA LAMA Absconding DOPR - Hospital, Healthcare - NABH

In this video, I have explained the differences between DAMA, LAMA, Absconding, and DOPR

DAMA - Discharge Against Medical Advice

LAMA - Leave Against Medical Advice or Left Against Medical Advice

Absconding patient - a patient leaving the hospital and no one is aware of it, till the patient cannot be traced anywhere

DOPR - Discharge on Patient Request

In my YouTube Channel, you will find many informative videos

on healthcare, NABH, ISO-9001 and Quality Management

Click on this link to go to my Channel

The Truth About Generic Medicines

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WHAT IS GENERIC MEDICINE

Generic medicines are, simply speaking, the same as brand-name medicines and have the same active ingredients, and are safe and effective. They are much cheaper than brand-name medicines because they do not have to go through the same expensive research and development process as brand-name medicines

Generic medicines are usually more widely available than brand-name medicines, because generic medicines do not have to be approved by the FDA as new medicines, so they can be brought to market more quickly Generic medicines do not have to go through expensive and intensive research and development, because they are manufactured based on already existing brand-name medicines which are already FDA approved

For further information click on this link - The Truth About Generic Medicines

HOW SAFE ARE GENERIC MEDICINES

Generic medicines are safe because they are subject to the same rigorous safety standards as brand-name medicines, and they are tested for both safety and effectiveness. Even then, there are small differences between generic medicines and brand-name medicines - the generic medicines may have different inactive ingredients or different colours or shapes. These differences are so minor that they do not affect the safety or effectiveness of the medicines, because the active ingredients are the same as those of brand-name medicines

What is active ingredient - it is that part of the medicine that makes the medicine work

What is inactive ingredient - it is that part of the medicine that help the medicine to work, but it does not have any medicinal properties

For further information click on this link - Benefits Of Generic Medicines

THERE IS A WORD OF CAUTION

If your doctor prescribes a brand-name medicine, which also has a generic equivalent, then, before you decide to take the generic medicine, you should talk to your doctor for approval

You should read the label of generic medicine very carefully, to make sure that the generic medicine has the same active ingredients as the brand-name medicine

Your doctor may recommend that you start taking generic medicine with a small dose first. This will help both you and your doctor to see how your body reacts to the generic medicine

When you first start taking a generic medicine, monitor your symptoms closely to see how well your body is taking the medicine, and report everything to your doctor. Thereafter, let your doctor decide on the best course of action

You should not give generic medicines to children without the advice of your doctor

Pregnant or breastfeeding women should talk to their doctors before taking generic medicines

For further information click on this link - Generic Versus Non-Generic Medicines

GENERIC MEDICINES DO NOT NEED FDA APPROVAL, AND THEY DO NOT HAVE TO GO THROUGH EXPENSIVE RESEARCH AND DEVELOPMENT PROCESS

The FDA approval process for new medicines is very expensive and is a very intensive time-consuming process. It can take many years to bring a new medicine to the market. Generic medicines do not have to go through this process because they are copies of already existing FDA approved brand-name medicines

But, generic medicines have to demonstrate bioequivalence to the brand-name medicines. This means that generic medicines must prove that they work the same way in the body as the brand-name medicines

The FDA has strict standards for bioequivalence, that is why generic medicines are as safe and effective as brand-name medicines

The manufacturers of generic medicines need to submit the manufacturing process to the FDA, to establish that they are manufacturing high quality medicines identical to the brand-name medicines. These manufacturers also have to submit the details regarding the active and inactive ingredients present in the generic medicine. In addition, there may be other requirements, which the manufacturers will have to comply with mandatorily

WHY GENERIC MEDICINES DO NOT NEED FDA APPROVAL

Generic medicines use the same active ingredients that are used in brand-name medicines, these active ingredients have already been scrutinised and approved by FDA before authorising the launch of brand-name medicines in the market. That is why there is no need to repeat the process of FDA approval for the generic medicines

It is mandated that the manufacturing process for generic medicines must be the same as the manufacturing process for brand-name medicines. This ensures that the generic medicines are made to the same high standards as the brand-name medicines

It is mandatory for generic medicines to meet the same quality standards as brand-name medicines, that is why generic medicines must be manufactured under the same strict Good Manufacturing Practices (GMP) as brand-name medicines

For further information click on this link - Everything You Need to Know About Generic Medicines

AUTHENTICATION OF THE MANUFACTURING PROCESS OF GENERIC MEDICINES TO PREVENT DEVIATION

This authentication is done by the Food and Drug Administration (FDA), through a process called Abbreviated New Drug Application (ANDA)

The generic medicine manufacturer must submit the ANDA to the FDA, to be eligible to market the medicine

This ANDA must consist of information about the generic medicine’s active ingredients, inactive ingredients, manufacturing process, and bioequivalence to the brand-name drug

The FDA reviews this ANDA. If the ANDA is approved by the FDA, only then the manufacturer can launch the generic medicine in the market

The FDA also conducts inspections of generic medicine manufacturing factories, to ensure that the manufacturers are following Good Manufacturing Practice (GMP)

If the FDA finds any deviations from GMP during an inspection, the manufacturer will be required to take necessary corrective actions to comply with FDA guidelines

For further information click on this link - Get more information on ANDA