Blog – Page 3 – Quality Management Systems

How to tackle warning letters in Pharma Manufacturing?

by pritam p with No Comment Blog

Pharma Manufacturing Warning letters are issued by the FDA to people or associations for infringement of regulatory importance. While they are naturally casual and warning, their definitive point is to set up intentional compliance with the law. This blog will display the best practices and proposals that can be utilized to enhance a Pharma covigilance association’s structure, create proper SOPs and procedures, measure the performance of critical PV works, and guarantee examination status.

Warning letters come with the variety of reason to blame or claim one pharmaceutical manufacturing company with valid forms from the FDA association. There are plenty of procedures involved in this manufacturing system, so there are chances of failure in any one or many of them. So it is truly hard to explain how to handle each one of the failures or the blames.

But now we will share with you how to tackle any Warning Letter from the FDA for the Pharma Manufacturing companies.

Proper and finish response to form 483 is significant. Following a review, the FDA will issue a form 483 posting its discoveries. The organization normally has 15 days to react. It’s fitting to utilize the accompanying accepted procedures while reacting to form 483. The following:-

Address every perception independently
Recognize the issue
Show a comprehension of the issue
Assess the effect and decide the reason
Depict rectification and precaution activities obviously and in a way that passes on comprehension of the issue and an exhaustive underlying driver investigation
If possible, amend infringement promptly and tell in 483 response
In the event that conceivable, give confirmation of these activities
It is critical that every response address the focal issue(s) recognized in the perceptions made by the FDA. It ought to likewise give real and target prove that can be assessed and help in understanding the response.

But, if reasons mentioned in the warning letter seems wrong to the manufacturing company, you can’t help contradicting the 483 perceptions, you have to help this with clear confirmation, actualities and information, and clarify why the perception is mistaken as opposed to just overrule the cases of the FDA.

Frequently when the FDA composes a warning letter, they need to report an organization’s absence of compliance against a specific control that has been damaged. It’s uncommon to see a general remark embroiling an extensive variety of things. They will dependably recognize the direction that has been disregarded. Subsequently, the most widely recognized discoveries from warning letters, for the most part, identified with Pharmacovigilance essentials, for example, multi-day reports, PADER issues and SOPs.

Rehash discoveries and poor responses to the form 483 increment the danger of a warning letter definitely and there are not kidding results for inability to amend the issues distinguished in the warning letter. An association must be proactive and set up procedures and techniques that keep these issues from emerging and in this manner dodge an FDA warning letter.

Passing the IATF test

by pritam p with No Comment Blog

Passing the IATF test IATF 16949 is basically developed by the IATF members and then submitted to the International Organization for Standardization, who are responsible for application and then their publication too. This certificate is very valuable as it holds acceptance of the common automotive manufacturer’s standardized application in the quality management system of the production house. Also it determines guarantee on the supply of improved quality of products for the automotive customers across the world.

This certification is not allocated to the companies very easily, there are stages in which the protocols are examined; they are:-

Application
Assessment
Certification

Passing the IATF test

Also there are finely segregated norms which comes in two separate stages in the process of the certification audit.

The Stage I confirms that the organization is ready for full assessment, which includes the following:-

The scope of processes, activity and operating locations are verified.
One corporate audit and records of internal audits for the last 12 months are reviewed.
KPI’s for operational performance and customer trends for last 12 months are reviewed. Elements involved in this review are:-
- Satisfaction of the customer.
- Complaints of the customer
- Imposed feedback of the customers, that affects the shipping controlor the special status.
- Delivery punctuality
- Score cards of the customer
- Internal PPM and external PPM
- Awareness and motivation of the employee
- Performance of the supplier and continual improvement issues

The Stage II confirms that the management system fully conforms as per the requirements of IATF 16949 by their practice, and includes the following:-

The scope of certification including processes,, manufacturing sites, operational shifts and additional customer specific requirements
Using objective evidences, documenting of the system complies with the standard
Reporting of any non-compliances and opportunities for improvement.
Confirming a date for the surveillance visit, as well to plan a surveillance plan

The Final Stage concludes with an assessment of the client’s success stories, training and by getting a quote.

Passing the IATF test When an automotive manufacturing organization has passed the staged examinations based on the quality management systems as mentioned, one company is eligible to obtain the IATF 16949 certificate.

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Discussing the Quality Metrics in Pharma System Implementation

by pritam p with No Comment Blog

Quality Metrics in Pharma System Producing and delivering the best quality product is all that any customer needs and any industry strives to achieve. And when it comes to the pharmaceutical industry, we cannot afford to take any kind of risk.

The Pharmaceutical Quality System is recognised as a very effective management system that dictates us to control and direct any pharmaceutical company with respect to the quality. This Pharma Quality Management System provides major elements of confirmation and deep-rooted testing necessary for pharmaceutical manufacturers and laboratory processes with quality control throughout the entire product manufacturing process. This process elevates from the development of the drugs through commercial manufacturing.

So, where we have known that measuring the quality of a product is very important for every industry, pharma can never afford to ignore it to the highest rate. And keeping that necessity in mind, we have prepared today’s blog to discuss some essentials factors for using quality metrics in the pharmaceutical industry. And it is not one or two of the metrics that measure the quality, but there are many such metrics which determines the quality of the drugs. We are often left with confusion and use the metrics according to the last man’s choice and reasoning.

In the process, measurement of quality metrics is a major necessity of the pharmaceuticals, for the following reasons;

To help the Food & Drug Administration develop the compliance and its inspection policies and to practice the same.
To inform the risk-based planning of drug manufacturing provisions, which should result to decrease in inspection rate for high achievers.
To Improve the predictive ability of the Agencies, which allows the easy action to possibly control future drug shortages.
To inform the FDA’s complete surveillance program by providing additional intelligence.
To encourage state-of-the-art implementation, quality management systems for innovative pharmaceutical manufacturing.

You have known that metrics hold utmost importance to measure the quality of an end-product. Thus we have been using several types of metrics to verify the work quality of the PQS. So, here we have enlisted the available list of best quality metrics that are being used in the pharmaceutical industry.

Lot Acceptance Rate
Invalidated Out-of-Specification (OOS) Rate
Product Quality Complaint Rate
The number of lots attempted which are released
The number of product quality complaints received for the product.
APRs or PQRs required for the product.
The APRs or PQRs were completed within 30 days of the annual due date for the product.

Some other quality controls apart from the quality measurement in metrics used by the Pharmaceutical Industry are the ones we have mentioned and discussed below.

OOS Investigation

Calculation of OOS or Out-of-Specification results can prove to be one of the most useful metrics. Before a pharmaceutical industry goes on manufacturing a medicine, it establishes particular acceptance criteria which are desired to be met at the end. And on the contrary, with the metrics of OOS, we can easily find out the rate of the products which have not met the acceptance criteria.

We have to review the production process if it is going accordingly or not and then take up additional laboratory work if needed. With the right usage of this metrics, we can not only derive the problems, but we can also take prevention actions in accordance.

Laboratory Investigation

This metric is kind of really serious one in the lot. It finds the cause of the OOS result and thus it examines laboratory work very precisely. This investigation may often end up with the rejection of an entire batch. And when a full batch of medicines are rejected by the quality unit, then they become more concern over checking the other batches as well.

Customer Satisfaction Investigation

This metric has always been very helpful. Nothing else can be better than getting a feedback from the users themselves. Because they have already used it. If the medicines have worked for recovering their health issues then there is nothing to be worried about and the industry can keep on manufacturing more and more of such drugs for the same health issue.

But if any one of the customers has reported a negative feedback then RED ALERT!!!! We need to check why it has happened and how we can improve from this situation.

We have been hearing that marijuana will be soon used to prevent cancer. But nothing has really happened till now because the pharmaceutical industry has not yet come up with positive results. They are continuously doing quality check by laboratory investigation and OEE investigation, but no proof has been gathered that it can cure cancer thus marijuana is still not launched in the market as a medicine for cancer.

The quality metrics used in the pharmaceutical industry helps us to detect whether there is anything wrong with the medicine and if it can offer the customers recovery from their health issues. It indirectly helps us to build trust in the market because people believe us only if we provide them with quality products. Thus each and every quality metric is essential for a pharmaceutical industry to come up with the best positive result.

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The Quality Metrics to Monitor in Manufacturing

by pritam p with No Comment Blog

Quality Metrics to Monitor in Manufacturing The first and foremost objective of any industry is to deliver quality products in the market. And it is definitely not a child’s play. You, being an experienced person in the manufacturing industry, are aware of the cons that might come because of producing a product which is not upto the mark. And thats why, to make sure that we are manufacturing worthy goods, we take the help of metrics.

Quality metrics are numbers that gives us an overview of the process running for manufacturing a product. It can measure the methods very minutely about the way these are functioning and if there is anything better that can be done to improve them.

The Quality Metrics to Monitor in Manufacturing

When we are on the verge of developing a business, the first thing to be done is to set a definite objective that can satisfy both customer and company needs. And thus the manufacturing process and the process metrics are done on that direction. We should keep the outcome in mind and then develop the metrics based upon that.

So, what are those most useful metrics deriving desired results and how are they helping the manufacturing industry!! Let’s find that out with the development of today’s blog.

Process of Quoting

Suppose, amongst many of our business objectives one is to increase household goods business from 10% to 40% of it which will have a margin of minimum 25%. And then according to the expected result of this method, we will be using the metrics of accepted quotes which will later transform into the Point of Sale by the customers. The quotes should have a margin of minimum 25%, as a result it will increase our business of household goods.

After doing all the necessary steps, we have to begin quote data collection from different sectors doing business of household goods, the calculated margin based on quotes, the real margin generated from first few orders, and also to what volume the business has developed by the quote. With these data in our hands we can then easily calculate the metrics of:

The percentage of household goods quotes with margins above 25%
The percentage of household goods business volume from the particular month’s quotes

We can track these data monthly based on this metrics and can also increase sales.

Process of Product Upgradation

Companies often come up with the upgradation of existing products. For example Apple does that every year; they have an existing product iPhone which is being upgraded on regular interval – thats why from its first launch in 2007, it has now been upgraded to iPhone X.

So, lets assume that one of our business objectives is to boost up the sales of upgraded products from the last 2 years to a percentage of 25 of our yearly sales volume with a margin of 30%. For this, we have to upgrade our product in a way that can attract the market and satisfy the customer needs. After that, we have to collect the sales data when the upgradation was getting designed, the quoted margin, the margin on the first upgraded production run along with the customer ppms of that time. This will help us to track the metrics of:

The percentage of sales of the upgraded product
The percentage of sales of the upgraded product with a margin of 30%
Customer ppms on the upgraded product

With these data, we can design our upgradation in a fruitful way which will give the desired margins with zero problems from the customers.

Process of Upgraded Product Launch

The upgradation of a product requires a good launch as well just like iPhone does every year. So, our upgraded product launch process should launch the upgradations into manufacturing without any problem either from the customer or from the manufacturing aspect. Then we have to move on towards collecting data of the nonconforming upgraded product for the 1st and 2nd upgradation runs along with the complaints from customers for the same. This data will assist us in tracking the metrics of:

Internal ppms for 1st and 2nd product upgradation runs
Customer ppms ppms for 1st and 2nd product upgradation runs which will not be related to the designs

This metrics will let us track the performance of the upgraded product launch process.

Quality Metrics to Monitor in Manufacturing So, we have to develop such metrics which will make our business relate to the desired objective and the results as well. Then, along with customer satisfaction and trust, our business will keep on improving on the way ahead.

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Know about MTBF & MTTR and their Relation to FMEA

by pritam p with No Comment Blog

MTBF & MTTR Mathematics have problems, but it has solutions to that as well, right!! Actually every problem has a solution to it – be it big or small – we just need to find out the right path towards solutions.

Success and failure are the two core parts of our lives in every state. A company experiences both in their field of work; but they know to stand up from the failure as well. And to bring ourselves out of the situations of failure, we first need to analyse and measure our faults. And we will come to know our faults, we can ignore them easily. So, how companies are measuring the failure rate and how effective are those tools – this blog will talk about.

For most us, failure is counted as when a machine or a system is not working properly, or fulfilling the objectives according to industry desires. And in industries, there are certain parameters to measure that rate:

MTBF – Mean Time Between Failures
MTTR – Mean Time To Repair

mtbf
Let us first discuss about MTBF and then we will move onto MTTR…

MTBF

Failure does not come once, and with machines, it can definitely happen a lot of time because though we are running them, we cannot control the internal defects. And to make ourselves a bit more aware of the time they can take place, we have adapted the measure of MTBF. It actually calculates the average occurrence time between one failure and the other, thus helping us to get an overview of when it can happen again so that we can avoid them if possible.

Look at the formula of calculating MTBF:

mtbf 1

Total Uptime = For the time span a particular system or machine is running.

Number of Failures = The number of failures taken place within this period.

And this method also helps us to know the failure rate per hour with a formula of:

mtbf 2

By diving 1 by the result of MTBF, we can easily calculate the failure rate.

This process actually assists us in predicting the performance of a machine and how many failures it can do in an hour. In result, prevention can be taken accordingly as well.

MTTR

Now moving onto the next measure of MTTR, as we discussed while talking about MTBF that we cannot control the internal defects of a machine – it is true; but we can definitely repair that defect. It may take time, but it can definitely get repaired.

So, MTTR is actually the preventive measure we talked about while explaining MTBF. This lets us calculate the average time taken for the repairing of that particular machine after the failure.

Here is the formula:

mtbf 3

Total Downtime = For the time span a particular system or machine has stopped working.

Number of Failures = The number of failures taken place within the total uptime.

By analyzing the average repairing time, we can pick the time according to our convenience.

Both these tools are helping industries to increase the productivity and decrease losses effectively. It indicates the performance of an industry – how well it is working, with which we can improve the quality of work.

An increased result of MTBF and on the other hand, a decreasing rate of MTTR will mean that the company is performing well, which will heighten customer reliability towards the company and its products or services.

There is a core relation between these two tools of failure measurement and FMEA (Failure Mode and Effects Analysis). As the name implies, failure modes actually detect why the process has failed and effects are the outcome that the company may face for this.

mtbf analysis

When we come to know the failure rate and the average repairing time, the reasons also need to get analyzed. This is done by FMEA. By identifying the defects within the process, companies can easily avoid them, as we were saying in the entire blog. There is no other better way to detect the reason of the failures and to correct them than FMEA.

And obviously, when we know the reasons and the time of failures, we can smoothly get out of that. Thus we can keep up the quality of our company.

For better understanding and explanation, here is an example:

When a bucket manufacturing company has detected the failure rate of the manufacturing machine, it will start analyzing why these failures are taking place – is the machine being unable to work after a certain period of time or the reason is something else!! And after that, the average repairing time will be calculated. All these will help to reduce the failure and become more productive.

MTBF and MTTR are core planning tools which tell us exactly when a particular equipment or component needs to be repaired. We need to add something on that too.

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Are 15 days enough to get ready with ISO/IATF 16949

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ISO/IATF 16949 Hello and welcome to this blog that will tell you how to prepare for a transition to IATF, and will estimate you the evaluation of the hours or days or months needed to do the mentioned. A change is definitely a big difference when it is for a company specially in auto industry. Like we know that work spaces before the inclusion of computers and digital applications or softwares, were completely different. Employee used to maintain stock in papers by counting each of them, this sort of manual calculations were done for releasing finished products, delivery, company accounts, employee wages and even the company profit. But now with the advanced technology companies are flowing in automated machine generated results, where manual effort is needed only to enter the details of the needful, the remaining calculation is done by a high or low priced application or software. Also, previously there used to be manual supervisors to inspect employee performance in office and industries, but new age’s CCTV camera has reduced man power engagement and even does sincere work than any other manual supervisor. Which means the transition is mandatory, that which needs time is the adaptation behind the change. That is how a transition is always a matter of adaptation with the new environment or habits and even procedures sometimes, that applies with our ISO/IATF 16949 as well.

We all know to start a big evolution, some plannings and preparations are which play the leading role. So for this process of transition to IATF, one company can prepare all documents and formulate module within some days that may vary between 10 to 15 working days, but to incorporate the changes it takes a long time, even months and around 6 to 9 months.

So, in the process of compliance of the IATF 16949 with the respective company, there are some methods that undergo this process, namely, balance innovation, safety and affordability.

Balance Innovation: Making requires creativity, as the creation is the customization of various noted facts, mechanism, algorithm and hardware – this should be done with intense care and post production view. And thus the innovation should be meaningful to have a balance in the use of it’s anatomy.

Safety: Being safe is always better than taking unnecessary risks. The adaptation of ISO/IATF 16949 also needs to be processed under proper safety for fruitful result.

Affordability: Having money does not mean we can spend it like dust. Everything need to have a budget because industries have several other expenditures. So, alongside the above mentioned processes, we should also take care of the costing by strategic investments.

ISO IATF 16949

These above said procedures are not covered up in hours or days but it involves months of mechanism to attain the result of transition. Time is a valuable thing, which if utilised, the outcome mostly results good. So the days spent in transitional processes are well calculated as that brings the foundation of the module that is being applied for the post productional work of the company. It becomes easy when we are developing a strategic breakdown for each activity that includes our compliances for the transition of the ISO/IATF 16949.

And according to the mentioned facts expressed in the above part of the blog and also references from other sources bring a conclusion that transition of the IATF new certification is not possible to cover in 15 days of period, but it takes more time for around 6 to 12 months in total to prepare every part of the transition process.

This period of ISO/IATF 16949 transition should be taken care of, as this is the company’s Automotive Force installation period which will make it run as a power house leading to manage a quality operation in the systems.

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5 Effective Steps to Monitor Your Quality Management System

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5 Effective Steps to Monitor Your Quality Management System Implementing a Quality Management System in an Organization is always a challenge. A well implemented QMS system needs several important measures to be captured and tracked. So which exact parameters must one track? In this blog I will try an highlight just a few high steps to monitor effectivity of you QMS system.

With time, we have understood that there are a lot of metrics which can help us in the measurements. And when we are able to measure our quality of work, we can definitely improve them accordingly, if needed. Taking the example of Reliance can give us a better understanding:

In the beginning, Reliance network did not get nationwide acceptance even after proving the users with good connection. And then with the usage of right metrics, it has detected the issues they are coming across which led them in the betterment of their quality. They kept on providing free schemes, cost-effective recharges, and also became a quality internet provider. And now, you can see where Reliance stands – JioFi has spread everywhere around India and they have managed to save their position with a good Quality Management System.

But the question is how they did that? What are the metrics they used to detect the problems and bring out the best quality across the nation? This is the topic of our discussion today. So, let’s get into knowing those helpful measures that assisted Reliance as well as many other companies to manage their quality of work in the industry:

Notification of Documents

First of all, we need to understand that developing a good Quality Management System can work the best for any further improvement. So the first metric that needs to get discussed is the notification of all the documents of a company – starting from the collection, maintenance, identification, to the amendment of technical and quality recording holds core importance.

But to come up with the best result, we need to make sure that the employees are getting notified with this information because they are the ones who are working in departments for the manufacturing. Until and unless they are going aware about how the company is working, the chances to develop gets decreased. So, in first hand, Reliance had to make sure that their employees are all aware about the drawbacks answer well as the strengths to work upon accordingly.

Audits

Audit is a very common term used in every industry – starting from manufacturing to banking sectors. Without auditing one can never be able to take action. It is actually the analytics of the documents with which employees of the respective companies have already been notified. It is a great metric to sort out the problems, the actions taken for it, if the actions have been taken on time, the good work etc.

Reliance also made sure all of these facts with auditing because this is best way to analyze and improve.

Overdue Trainings

When we are recruiting employees in our company, even the smallest of the smallest ones needs them to get trained according to the requirement of the system. We have to make sure that all such training programs are up-to-date. If any kind of training is still remaining, we have to ensure to complete them as soon as possible. So we have to keep a track of this to check everything is done on time.

At times, these training programs also need to get improved and this can be best done with the feedback of the employees. They are the heart of any company; so we need to take care of them in any and every situation.

Risk Assessment

Taking risks in our lives is a dreadful thing to do. And with companies, it can at times become devastating. But risks have always been a core part of any industry. So, we need to assess them correct them and that too well before time to take preventive measures. We must hold a record of those detected risks and the steps taken to get out of them. This record will aid us in detecting whether there is something else remaining or not.

Reliance really took a big risk while launching JioFi in their business but they had to take it for the betterment. And they made it, the risk was truly worth. They took all the measures to market this new innovation and the result was fruitful, we all know that.

Overdue Issues

Companies are facing problems every now and then. And most of the product related issues are reported by the customers with their feedbacks. So, companies need to have a track of all these issues and take necessary actions. But we must remember that in this case, the proverb of “Better late than never” does not work because the more we will delay in coping up with the issues, we will keep on losing the trust of our customers as well the quality of our company.

Thus Reliance truly coped up with all the issues they were facing in no time which definitely resulted in elevating them to the position of one of the top network providers.

5 Effective Steps to Monitor Your Quality Management System These 5 key steps can help monitor the effectivity of Quality Management System of companies. We will be happy to hear from you because your feedback has always been valuable to us.

Cheers!!

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Setting up Self Assessment Program for Quality in your Company

by pritam p with No Comment Blog

Self Assessment Program Let’s start today’s blog with a question – do you think that only taking several measures, planning strategies, selling high-quality services or products can take your company to the height of success!! No, you need something MORE… so what is that MORE thing!! This blog will talk about that!!

Self-Assessment

Self-assessment – it is one of the most effective thing to do for your company. As you know, the dictionary meaning of this phrase is ‘the evaluation of your attitude, action, and performance’. When talking about a company it is more or less the same which helps to understand what is the current position of the company and how can your company make its move to the path of betterment!! Self-assessment helps you measure the effectiveness of the work processes in your company.

When companies want to self-assess the quality of work, they need to go through some strategies. To help them achieve that I have enlisted and prepared some questions which you should follow as a model and I am quite sure this will work as most of the big companies follow these rules to assess their quality of work – be it Microsoft or TATA!!

The Tool of Self-Assessment

Read the questions below and start improving now…

Understand the Goals where you want to Run

t first, you have to understand what you want to achieve!! Have you not seen that in a Football game, the players always aim for their goals!! In that same way, you, as the owner or leader of the company, must know what are you seeking to achieve.

To give you a better understanding let’s take a look at the example of Google. Their aim was to make life easier and become a one-stop solution for everything starting from worldwide communication, social media to keep all your work safe.

So, first know what you want to achieve with either the product you are selling or the service you are providing. Is it just to sell and make profit or something more!!

Why you want to do this?

When you know what your goals are, ask yourself why are you doing this!! Just like the example I gave you before, Google did everything to become the powerhouse of whatever people need, to serve all their basic wants.

What is the Method you are taking upon?

Setting the Path towards your Goal

See, when you know the goals you want to achieve and why you are doing that, analyse the measures you are taking!! Until and unless you know the path you want to walk through, you will not be able to reach there. So knowing the process is very important for the quality of your company!!

Are you able to Reach Out?

Reaching out Goals

And this is the most crucial step while you are on the process of self-assessment. After analysing your goals and the method you have opted for it, this is the time for you to chalk out how far you have reached towards your goal and how much you have achieved!! Make a plan, call upon a meeting, discuss with each and every employee of your company if your strategies are working or not!!

Trust me, you should do it regularly. For example, keep on doing meetings on monthly basis with the entire company, and additionally, for the best result, you can suggest your employees to do weekly inter-departmental meetings. I am following this trend for quite a long at my company, and we have achieved much much better results.

Lets get Better…

Getting Better Everyday

Here, you have known what your position is and how good is the evolution of your company. Now, you have to think if there is any scope to do something even better. There are several ways to do that, amongst them one I have already mentioned in the previous point – weekly and monthly meetings.

Along with that try rejuvenating your employees with events, keep on encouraging them towards work – this will help them to grow more confidence and improve the quality of your company. Keep in touch with them, dont make them feel that they are working alone!!

I can give you one of the most lively examples of regular improvement of this era – Whatsapp. They are continuously improving their quality. At first, they were just the platform from where you can chat with your friends and share media (that too of limited counts to 10); then they updated to voice calls, then video calls, then updating stories as status, and so on. And you know what’s the best part!! They are improving everyday with something new which is actually impossible without self-assessment!!

You will only get the correct result as desired when you will ask yourself all these questions and then take steps accordingly. You cannot afford to skip even one of the questions and you should keep on practicing them on a regular basis, routinely, which I have already mentioned a several times in this blog.

Self Assessment Program For now, I will wrap up today; but you keep yourself notified with my blog updates as I will soon come back with something new for helping you improving the quality of your company!! Have you looked at any QMS software yet? Please let me know…

Thank you!

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Are Statisticians needed to read a SPC Chart

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SPC Chart Have you ever given it a thought that how important is statistics in our everyday life!! Maybe we don’t do graphs or statistical calculations every day, but still we are using it in other ways like calculating the average expenditure, determining the weather with some probable conditions, and so on.

But,this is not so easy in case of companies. They make use of this subject in every step, and that too not like everyday life. They need to do graphs, diagrams, calculations in order to determine their position. We often name them as Statistical Process Chart (SPC) where one creates a graphical diagram of the performance being measured and then determine the measures needed to take accordingly.

Statistics is often considered as one of the most tough subjects to study – both in practical and theoretical situations. Well theory is a bit tough though; practically, at times, this may not be the case!!

And after listening to this, the first question that comes to the mind is that will you need a statistician to read SPC Chart which probably is part of you QMS software in your organization!! Well, to understand that you first have to know how does a SPC Chart looks and how does it work. Take a look and then have a read:

Very distinctly speaking, SPC actually tells you about how various process of your company has changed with time and if it is affecting in a good or a bad way!! With SPC Chart prepared in your hand, you can easily monitor the manufacturing process which is definitely needed to improve the quality of work. Until and unless you can evaluate the manufacturing process rightly, the improvement of you company will also be slow!!

Just think a bit statistically, ThumsUp has recently launched a new variation – Charge!! Do you think that started producing this without any kind of data analysis!! Of course, not!! They have studied the market that people want to drink something which will be not so sugary yet not even a diet one and have then taken the measure to produce this superhit drink!! And now they have prepared SPC Chart to monitor it which will ensure continuous improvement.

To prepare this chart, you simple need to combine some classical methods of statistics with the time improvement. With chronological analysis, you can then determine the changes in the process and its effectiveness. And as you can see in this chart, this is not so difficult that you will need a statistician to read them!! Yes, SPC Chart can also be read without a statistician because of its simplicity but learning a few basics is important you just can’t start interpreting them.

SPC Chart These charts lets you change the process of production continuously, if needed, as it tells you whether the prior ones are working rightly or not. SPC Chart has always been very effective measure for the continuous improvement and to manage the quality of your company since late 1920s. Companies are still working with them and that too without the inclusion of any statistician.

So, SPC Charts are comparatively easier to understand than any other statistical method. But still, if you come across any other question regarding this process, feel free to type your questions in the comments box below and I will answer them!! And do not forget to leave your feedback on this blog because it will help me in my continuous improvement and quality management of my blogs!!

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Will Additive Manufacturing reduce Quality Costs

by pritam p with No Comment Blog

Additive Manufacturing reduce Quality Costs is not yet mainstream in India. In case you want to know more about Additive Manufacturing look at these links for a quick read

http://additivemanufacturing.com/basics/

https://www.technologyreview.com/s/513716/additive-manufacturing/

The technology is yet to be adopted since the costs are still prohibitive compared to traditional manufacturing techniques. Just for a sampler Aluminium Alloy powder( LM6) costs almost Rs. 2000 a kg wheres the same alloy costs Rs. 170 Kg ,also the latest additive machines take hours to print a single part, so it’s a no brainer that it’s yet to be adopted. Bringing down the input powder costs doesn’t seem to be on anyone’s mind in India yet but expect the unexpected soon.

The technology per se for manufacturing the powder is not very new with Gas atomization being the most popular technique. So why no push towards this technology? Well only the industry has answers to these questions but it got me thinking will additive manufacturing reduce quality related costs the obvious answer seems to be a yes. So how could quality costs be reduced with Additive Manufacturing?

You get an almost 100% density with additive manufacturing so especially it seems a good option in replacing casting techniques with pretty certainty that unfilled parts will never come out of 3D metal printers. They might also result in better yield but speed? That’s another question.

Additive Manufacturing reduce Quality Costs For surface finish I am still not sure the level of finish can achieve with 3D printers but if we can get good finishes VMCs and CNC’s will have a run for their money but there’s still time and it still looks like a pipe dream for now.

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