FDA eyes on "Antibacterial Soaps"

US FDA nowadays are more vigilant on the antibacterial soaps; as per a senior microbiologist from FDA reveals that they have not found any significant changes in results when a person is using ordinary soap or antibacterial soap with water to clean body parts.

Generally to add on antibacterial properties to the soap;the triclosan is used by companies which has its own health related risk while using triclosan in the product.

FDA are working on same and the matter is under study and may be possible that FDA gives instruction to companies to specify that what is additional benefit of using antibacterial soap as compare to ordinary soaps on the product itself.

Ban on five Parabens by European Union from feb 2014

As per European commission draft notification published in Oct 2013.The five parabens are going to be banned in the Europe effective from Feb 2015...the following are the names of those parabens:

1.Iso propyl paraben
2.Iso butyl paraben
3.Phenyl paraben
4.Pentyl paraben
5.Benzyl paraben

Also European Commission restricting the use of Triclosan as preservative in the cosmetic products. 

What is the difference between TDS and Hardness of water??

TDS is the total amount of inorganic and organic salt ions including all minerals present in the water on the other hand Hardness of water is the measure of calcium and magnesium ions present in the water....

8 QM (Quality Management) Principles- Backbone of ISO 9001:2008

If we say that the following "8 QM Principles" are the backbone of ISO 9001:2008 worldwide accepted Quality Management System, it will not be an untrue words.The whole standard of ISO 9001:2008 are developed only on the consideration of these 8 QM Principles which are mentioned as below:

Principle 1: Customer Focus

Principle 2: Leadership

Principle 3: Involvement of People

Principle 4: Process Approach

Principle 5; System Approach to Management

Principle 6: Continual Improvement

Principle 7: Factual Approach to Decision Making

Principle 8: Mutual Beneficial Supplier Relationship

These principles are godly words for any organization, interested in making their Quality Management system stronger and more fool proof to ultimately gain more profits for the company by the means of achieving more consolidate "Customer Satisfaction"...

How to Draft an SOP (Standard Operating Procedure)???

The drafting of an SOP is indeed an specialized technical job but the basics of all the SOP writing are nearly same. There are some common headings which are the integral part of any SOP, and can be mentioned as follows;

1. Objective.....It includes that what is the purpose/objective of writing this SOP.

2.Scope....Scope means to whom concerned departments/people , this SOP are applicable

3. Responsibility...It defines that who are directly responsible for the implementation of said SOP

4.Accountability...It defines who are the accountable people, to ensure the effective implementation of the SOP and sustaining the same.

5. Procedure:  Here includes the step wise detailed description of the whole process/procedures to be followed.

6. Allied Documents/Formats: It includes the list and details of those formats/records/documents which are inter-related with the concern SOP.

7. Revision History: This portion of SOP includes the all back history, if any revision was made to the SOP with proper reason for revision and date of revision.

8.Prepared By, Checked By & Approved By: Here are the name and designation of those people who has prepare, checked and approved the SOP.

Once the SOP gets its proper concerned approvals,now it is ready for the circulation to concerned department/Process owners and from here "SOP" will starts the journey of implementation....

What is Reverse Phase and Normal Phase HPLC techniques ??

HPLC is basically consist of two types of separation techniques I.e. Normal phase and Reverse phase techniques....;

In normal phase HPLC techniques the stationary  phase is  polar in nature and mobile phase is non polar in nature

The vice versa is true for the Reverse phase chromatography in which stationary phase is non polar and mobile phase is polar in nature...one of the such common example is the combination of C18 bonded silica as stationary phase and methanol as mobile phase....

What is the difference between Calibration & Verification of an instrument????

Calibration of an equipment is an well defined activity to be done at regular interval may be once in a year or half yearly even quarterly to ensure that all the components of equipment are working fine and are as a whole equipment is been capable of producing precised and accurate results each and every time.Apart from defined frequency after any major servicing or maintenance if equipment or in case of wrong suspected results produced by equipment;the calibration has to be done.

Verification is somewhat a reassuring kind of activity to be done on daily basis most commonly...giving the assurance that after calibration still the equipment is working fine and if any problem arise in equipment that vll be identified and sorted out at very initial stage....

3М- МÚĎÁ ,МÚŔĨ & МÚŔÁ

Dear friends as we all know that japan is always been a leader in world in terms of quality and best manufacturing systems origination.

The words Muda,Muri & Mura are also japanese words which are  related to process improvememt.

Muda means "Waste"......

Muri means " Strain".....

Mura means " Variation"

Lets talk briefly one by one abouts these three words :

Muda is any kind of waste generated during the whole process it may be rework,overproduction or excess inventory.....

Muri is the overburden or strain on the machines or employees.....

Mura is any kind of variation present in the process i.e. it may be equipment variation or operation variation or process originated variation...

The general theory is that if any organization takes the necessary actions to eliminate these three enemy of profit and quality for any organization i.e. muda muri & mura, it is needless to say that the product quality and net profit will be more achievable for the company...

Thanks....

Attached pic resource:loginlogout.blogspot.com,this is only for reference purpose.

  

Technical Words drilling......

Sometimes technical words having long definitions but when it comes to explain it to a non technical person ,it  is too difficult to express it in simplest words....right now i am  recalling some words which are as follows and lets try to go close to real meaning of these words in simplest and shortest words-

1. Hazard and Risk

Hazard is anything that can cause harm.

Risk is a Chance may be high or low that somebody harmed by the hazard.

2.Continuous and Continual

Continuous is something increasing  regularly without any consistency

Continual is a increment in a sustained and stepwise manner that means just like a ladder in which there is an increment then there is a sustained step and so on

3. Accuracy & Precision

Accuracy is closeness to the truth

Precision is closeness to observation

Thanks...

Preservatives in Cosmetic & Food products

Dear Readers,

We all each and every one at some point of time used the any kind of processed packed food or cosmetic products in our daily life....but the question arises in an common man's mind that how these products remain absolutely fit for use after such a long period...the answer is the use of preservatives in such products makes them to be in okay condition and increase the shelf life of product significantly but generally without any deterioration in the quality of product by any means....

The word "Preservative" can be broke down into two simple words Preserve + Additives i.e additives which are added to products to preserve it.By science community, the preservatives are classified into two categories-

i) Class I Preservatives- These are naturally occurring substances for example vinegar,salt,sugar,honey,vegetable oils, as most of them are used in a traditional way from ancient times specially in India...i have grown by seeing the use of these substances by my mother to preserve the food items for a longer duration and these class of preservatives are absolutely safe for the use.

ii) Class II Preservatives-  These are synthetic chemicals likes benzoates,sorbates & sulphities....

The most common preservatives used in the cosmetic products like shampoo,lotions,gels,shaving creams and toothpastes are "Parabens". Chemically parabens are para-hydroxybenzoate...for example methyl paraben,propyl paraben

But some recent research has indicates that Parabens are not very safe for human body for prolonged use..hence companies are studying currently to replace the parabens from product by a safer option of preservative.

Moving ahead in discussion,one of the another good example of the synthetic safe preservative called as Phenoxyethanol. Its synthesis having the basis of a ancient plant which isknown for its anti-microial and anti-bacterial properties.  

The following is the list of preservatives which are generally used in the cosmetics and processed packed food products, some of them are to be used in a well defined and manner and concentration by various food & cosmetic regulatory bodies throughout the world:

1) Formaldehyde and Paraformaldehyde
2) Salicyclic acid and its salt
3) Propionic acid and its salt
4) Sorbic acid & its salt
5) Sodium Iodate
6) Chlorobutanol
7) Triclosan
8) Benzyl alcohol
9) Sodium benzaote
10) Benzethonium chloride

The government regularities bodies has made the Law in such a way that every manufacturer has to declare the details of preservatives which they have added in the product..so be aware next time when you use a product that you are using a product with safe preservative added or not.......make yourself and your loved ones aware about the fact that preservatives are boon at the same time may be dangerously harmful to your body....

   

Six Sigma- Basic Introudction

Six Sigma- A word quite common in every sector of companies nowadays but still a puzzle for "n" numbers of the people working in industry including me also prior to the introductory certification course completed by me of Six Sigma...

By means of this article i would like to share my thoughts on the introductory portion of Six Sigma Approach.

"What is the Purpose of Six Sigma and its origination"???

The very basic and simplest answer to this question is to make customer happier and increase profit. The whole approach of six sigma is to improve manufacturing process by eliminating defects.Six sigma approach was first developed by Motorola in 1986 with the objective of improvement of manufacturing process and correspondingly profits for company.

In the last few decades more of world class companies like GE,Allied Signal,Johnson & Johnson,Honeywell and many more has Opt for the six sigma approach.

One most common example whenever any body talk about Six sigma is Landing capability of a pilot on landing strip that means how close he can land the plane each and every time close to the target line.

"What are the Current Leadership Challenges"?

- Delighting Customer

- Reducing Cycle times

- Technology Advances

- Retaining People

- Reducing Costs

- Responding Quickly

- Flexibility

-Growing oversea market

- Retaining to the Best employer in the market is the main challenge 

Classic Examples of Six Sigma:

Motorola: -5 fold growth in sales 

                - Profit climbing by 20% pa

                - Cumulative savings of $14 billion over 11 years

General Electric- $2 billion savings in just 3 years

Betchle Corporation- $200 million savings with investments of $30 million..

Note: Initial investment has to be done by company in implementation of Six sigma at workplace ,later on in turn big benefits are observed in terms of increase profit and more quality product.

Six Sigma Philosophy:

@ Know what important to customer (CTQ)

@Reduce Defect (DPMO) 

@Center Around target (Mean)

@ Reduce variation (High Standard Deviation)

Note: DPMO level of 3.4 is equivalent to six sigma level of a process.

How to choose an Six Sigma Project?

To understand how organization can work on the identification of Six sigma project, refer the below flow chart (below chart is taken from the website :sixsigmatraining.org only for refernce purpose)

After the identification of Project the work whole Six sigma process is depends upon the 'DMAIC" theory..

D stands for Define the problem

M stands for Measure the criticalilty of problem

A stands for Analyze means collect the concern data and analyze it to find the root cause of problem

I stands for Improve means after analyze the core issues work towards to improve it

C stands for Control means sustain the improvement implemented and do it regular monitoiring.

There are diferent categories of courses in six sigma approach i.e. yellow belt,Green belt,black belt and master black belt.

Six sigma itself is a very deep and vast topic which can be feel by pratical Apporoach only.The basic objective of this article is to share just abcd of six sigma approach....

Note: In six sigma the sigma stands for the standrad deviation which is an statistical term to meaure the deviation in a process from its average value..

Im my opinion if any organization takes serious interest in six sigma process approach,the return vll be only procees improvement and many fold profits....

  

ISO 9000- Update on New Revision in 2015

Over a successful 25 years of ISO in providing the best proposed and proven managment systems to the world,now ISO is all set for the revision of the ISO 9000 in 2015.

After the major revision in year 2000 this will be an next major change, as per current information the generic standrad will be there with some new terminologies and revised and new clauses.

Some of the expected changes may be likely the term "Product" will be replaced by the "Goods & Services" and lots of more terminological changes.

The draft version of ISO 9000:2015 is now released and the final version is expected to be released in september 2015.

The primary objective of the ISO technical commitee is to include the current trends of QMS in the world and make it more and more compatible with the other version of the ISO management systems and also to provide a revised form of ISO 9000 which can withstand with the new needs of a world class quality management system in coming next years until next major revision in same.

The rough draft version of ISO 9000: 2015 can be study from here >
www​.qualman .co.in/WD_-_ISO9001_ ...

Lots of good expectation from ISO 9000:2015 version ....

Vocabulary for Quality Management System-ISO 9000

1.Quality:The Totality of features and characteristics of a product or service that bear on its ability to satify stated or implied needs.

2. Quality Policy: The overall quality intentions and direction of an organization as regards quality as formally expressed by management.

3. Quality Management: That aspects of the overall management functions that detremines and implments the quality policy.

4.Quality Assurance: All those planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirement for quality

5.Quality Control: The operational techniques and activities that are used to fulfill requirements for quality.

6.Quality System: The organizational structure,responsibilities ,procedures,processes and resources for implementing quality management.

7.Quality Plan: A document setting out the specific quality practices,resources and sequence of activities, relevant to a particular product service,contract or project.

8.Quality Audit: A systematic and independent examination to determine whether quality activities and related results comply with planned arrangement and whether these arrangements are implemented effectively and are suitable to achieve effectives.   

9. Inspection: Activities such as measuring,examining ,testing ,gauging one or more characteristics of a product as services and comparing these with specified requirement to determine confirmity.

10.Deviation Permit/Note:Written authorization prior to production or before provision of a services to depart from specified requirements for a specified quantity or for a specified time

11.Non Conformity: The non fulfilment of specified requirements.

12.Defect: The non fulfilment of intended usage requirements.

13.Specification: The document that prescribes the requirement with which the product or service has to be confirm.

14.Observation: A statement of fact made during an audit and substantiated by objective evidence.

15.Objective Evidence: Qualitative or quantitative information, records or statement  of fact pertaining to the quality of an item or service or to the exixtence and implementation of a quality system element which is based on observation,measurement or test and which can be verified.

What is TDS (Total Dissolved Soild) in Water?

TDS is an expression for the combined content of all in- organic and organic substances contained in a liquid which are present in a molecular,ionized or microgranular suspended form

TDS is generally considered not as a primary pollutant that means it is not deemed as to be associated with direct health effects but it is rather used as an indicator of asthetic chracteristic of drinking water and as an aggregate indicator of presence of a broad array of chemical contaminant.

Total dissolved solid is different from Total suspended solid in a way that TSS cannot pass through a sieve of 2 micrometer and yet are indefinitely suspended in solution...

Presentation on GMP

https://docs.google.com/file/d/0B1-SobcG-NzFcy01WkJoeU9BeEU/edit?usp=docslist_api

Presentation on Basics of QC Tools

https://docs.google.com/file/d/0B1-SobcG-NzFdVZtQXVhRjcwVmc/edit?usp=docslist_api

What is Quality of a product and What is the necessity of Quality Product

What is Quality.....

The first question comes in mind when we talk about the Quality Assurance/Control is 'What is Quality"?????? 

In my journey of being a part of the global Quality Assurance Community, i have learnt the various definitions of the "Quality"...Some of them can be shared as below:

"Quality is fitness for use" said by Juran

" The totality of features and characteristics of a product or services that can bear on its ability to satisfy stated or implied needs"..ISO 9000 definition

"Quality is the realistic property of a product which comply to specifications and the lead to customer satisfaction" that what i believe in......

Next point is Why quality requires????? Why a company requires to maintain the product quality??????? 

Reasons:

a) To be profitable

b) To reinforce personnnel quality standrad

c) To maintain customer satisfaction

d) To increase productivity

e) To increase competitiveness

f) To lower cost 

Phases of Quality Revolution:

The Quality Control has been gone through various revolution stages in the last century, these can be categorised as follows:

1) Operator Inspection

2) Foreman Verification

3) 100% Inspection

4) Statistical Sampling Inspection (SQC)

5) Statistical Process Control (SPC)

6) Total Quality Control (TQC) Statistical Prob. Solving (SPS)

So friends this is my a little effort to share some points reagrding the Quality and would expect your expert cooments on the same.

Please feel free for any of your thoughts which can be discussed on the blog.

In the next session we will discuss further on the "Quality Control Evolution"

Cheers!!!!

Quality Function Deployment

Friends, the topic which is very important during the product development stage and conception of a product is "Quality Function Deployment" (QFD).

In today scenario of market there are lots of options are available for a customer before buying a product as lots of market players are available, every customers wants a product which is cheap and best in quality not only this but "additional features" in the product.

So to consistently add the new additional feature in the product , the primary thing is to understand the customer needs and what they want....

To QFD is a process of product development and design to convert customer requirement  into the design requirement of a product.

Technical Definition of QFD may be:

A system for translating consumer requirement into appropriate company requirement at every stage from research through product design and development, to manufacture, distribution, installation and marketing,sales and services.

Different Phases of QFD process:

1) Product Planning
2) Part Developemement
3) Process Planning
4) Production Planning

Now when a company decides to go for the QFD, the project incharge and project team members should commit a good amount of time to it, majorly in the early stages.

One of the important tool in the QFD process is "Communication"

There may be two conditions for the QFD team formation:
a) New product development
b) Improving an existing one

 Advantages of the QFD:

- Improved quality
- Improved Profitabitability
- Incerased Customer Satisfaction
- Lower cost in design and manufacture
- reduction in design changes/problem
- Improved communication with the customer
- Improved documentation
- A more customer oriented work force

Some of the well known companies of world has been adopted the QFD, to improve their services and product Quality:

IBM computers
Du Pont chemicals
Texas Instruments
Philips International
GVC Elastomers

Constructing the House of Quality:

As QFD concentrates on the customer expectations and needs, a research has to be carried out to know the expectation of customer regarding the product under QFD process...

During the collection of the information, the QFD team must continually ask and answer numerous questions,such as-

-What does the cutomer really wants?
- What are the customers expectations?
- Are the customer's expectations used to drive the design process?
- What can the design team do so achieve customer satisfaction?

The constituents of Chart of Quality may be:
1. What customer wants
2.Rank of Customer wants (relative importance)
3. How these wants can be met out
4.Relationship between what and how
5. How much these wants can be met out
6. Targets values of customers wants
7.Interrelationship (Technical)
8.Competition from other existing product (Rating)
9.Compare with bench mark
10. Regulatory items
11.Relative importance of customer wants


At the end we can say friends that "QFD" provides a opportunity for the conversion of "What" customer wants into the real product....