IoT AND OEE

IoT AND OEE

Iot, an abbreviation for ‘Internet of Things’ and a fascinating ubiquitous digital phenomenon is rapidly affecting all things in the world of industries and businesses. The manufacturing sector assuredly has tremendous gains to garner if it welcomes IoT with open arms. Already, by bestowing rich, actionable data to sensor-fitted machines, IoT is unfurling remarkable progress on factory floors.

The Overall Equipment Effectiveness (OEE), a reliable metric used as a baseline and benchmark to measure equipment efficiency has reportedly made significant progress with of IoT application. As per ARC Advisory’s Industrial IoT / Industry 4.0 Viewpoints OEE has showed an improvement of 24 percent – pretty impressive results for initial trials.

IoT – THE HARBINGER OF NEW CAPABILITIES

 IoT bestows multifarious benefits to OEE, thus impacting it positively and helping it grow on upward curves..

Enhanced machine understanding for a better OEE

Modern-day machinery when digitally adjusted with the IoT ecosystem acquires fruitful dimensions to perform better. IoT enhances our detailed understanding of equipment primarily by way instrumentation and analytics, in turn, increasing OEE scores.

You might also like note that when a firm combines IoT applications along with machine learning via Artificial Intelligence (AI), it opens doors to a much bigger array of possibilities. The chief service offered by IoT analytics (sensor analytics) on OEE is the

measurement of time taken by machinery in manufacturing products.

IoT Connecting with devices

IoT Connecting devices

Significant contributions for improved production line

Significant improvements via IoT data feed can also improve OEE by helping it focus on the production lines. Amid concerns over machines, issues related to shifts and change-overs during production run tend to get neglected. A plentiful of benefits could be derived by use of sensors to time-stamp and outline timelines of pertinent events, including ones stemming out of faults in machines. The data when treated and analyzed by learning machines will reveal reasons for time loss.

“IT’s INEVITABLE. EMBRACE IT.”

Indeed, IoT works wonders on OEE. So brace up your machines to let IoT splatter it bountiful of benefits. Dave Reiber, formerly of General Motors favouring IoT rightly states, “It’s inevitable. Embrace it.”

 

What to learn from the audit failures of Mylan labs

What to learn from the audit failures of Mylan labs?

With the popular level of growth we learn a lot about the innovative application in any field in the process, so do we find lessons when we see any popular failure case. Such an audit failure case was reported by the FDA inspection against the Mylan Laboratories Limited from Maharashtra, during the period of September 5th to 14th, in the year 2016.

As per the FDA case reports of the Mylan lab audit failure, there were two different stages where the failure has occurred.

Let us learn in detail about the failures as well the measures that could have been the best, which now onwards can be used by the others before they produce the product, and by the quality management systems.

Failure #1

Mylan Laboratories Limited has neglected to altogether examine any unexplained error or failure of a batch or any of its segments to meet any of its determinations, regardless of whether the batch has just been conveyed (21 CFR 211.192).

Their investigation did not achieve an assignable reason, nor did they take fitting corrective actions and preventive actions to guarantee that the huge “analytic bias” to which at last ascribed the underlying failure would not influence other systematic work in their laboratory.

Because of the identified failure, the laboratory choices are to be made based on scientific assessment, and that they are to decide if OOS laboratory results are the aftereffect of the laboratory procedure or the assembling procedure.

Lesson to learn:

The reaction is deficient on the grounds that they neglected to execute a corrective action and preventive action (CAPA) plan to alleviate mistakes that you credit to laboratory process.

What to learn from the audit failures of Mylan labs

 

Failure #2

Mylan Laboratories Limited has neglected to set up a sufficient quality control unit with the specialist to survey creation records to guarantee that no mistakes have happened or, if blunders have happened, that they have been completely examined (21 CFR 211.22(a)).

Their quality unit neglected to screen and research blunder signals produced by the modernized frameworks that they use for elite fluid chromatography and gas chromatography. These signals demonstrated the misfortune or erasure of unique CGMP analytical information. In any case, their quality unit did not thoroughly address the mistake signals or decide the extension or effect of lost or erased information until after these issues were checked on amid our investigation.

Amid the assessment, our specialist saw that the Enable 3 framework review trial showed numerous cases of a “Project Integrity Failed” message, which demonstrates that infusions were absent from the aftereffects of analytical testing.

Lesson to learn:

The reaction is deficient in light of the fact that they have not distinguished and researched each case in which information obtaining has interfered. While they surveyed a predetermined number of mistake codes from a multi-day time span, they didn’t assess the impacts of other blunder codes recognized in the reenactment practice write about the unwavering quality, acuteness, or fulfilment of the information they used to assess the quality of their drugs.

What Is Lean Manufacturing And How it is Related To QMS

What Is Lean Manufacturing And How it is Related To QMS

Introduction

Across the world, in the realm of manufacturing industries, Lean Manufacturing is gaining a growing acceptance. As a sociotechnical production methodology Lean believes in banishing all waste while maximizing productivity. Today, several big manufactures like Nike and Caterpillar Inc. as well as those in non-manufacturing sectors are successfully implementing its principles which find their echo in the QMS (Quality Management System)

5 Core Principles & Working of Lean Manufacturing

Lean Manufacturing works on the basis of 5 core principles which include – value, the value stream, flow, pull and perfection. When an organisation works out of this value system, emphasises value while adhering to customer’s expectations, detects  processes entailing waste, Value stream-lines processes harmoniously into an uninterrupted flow, and when unnecessary exercises production restrain.

Lean principles

 

How Values of Lean Manufacturing and QMS Overlap

Value

Value, for both QMS and Lean manufacturing entails valuing customers satisfaction. QMS also believes in following safety and environmental standards set by authorities. Firms following Lean Manufacturing and QMS draw out the objectives on the basis of ‘value’ and ‘standards’. The subsequent blueprint for achieving is also based on the same value system.

A QMS system takes into account customer’s needs and encourages firms to haul their activities in accordance with them. An order from customer is met only when after formally establishing that the company is fully capable of meeting it. Targets setting, KPI or key process indicators are set at this stage on values similar to ‘value’ principle of QMS.

Value Stream

The Value stream of Lean Manufacturing seeks to line processes harmoniously into an uninterrupted flow in the manufacturing operations. Lean follows this principle for the execution of its blueprint. Though, initially, this is done only on a trial basis. The idea behind this is to check whether the process generates maximum output while engaging into minimum waste.

Under the column of Product Realization, QMS states that – “The organization shall plan and develop the processes needed for product realization (production).” Thus, it also calls for processes to be streamlined for harmonious activity of production.

Flow

Firms need to concentrate on a process that ensures smoothness in the flow of the remaining steps. Lean Manufacturing experts have devised some useful strategies to ensure the principle of ‘flow’ be followed, these include: breaking down of processes into steps, reconfiguring the range of production steps, evening out the workload, creating cross-functional departments etc.

QMS, too, believes in a thorough checking of quality of the processes and activities involved in production before executing them. Section 8 comprises subsections of Continual Improvement, Corrective Action and Preventive Action which at places overlap with the Flow principle of Lean.

Pull

A pull-based system believes in limiting inventory and it sees to it that the requisite material and information are available for work in process (WIP). Hence, a pull-based system can fulfill a Just-in-time delivery and a manufacturing system wherein products are created as per the end customers’ requirement. Working backwards in the production stream ensures better quality of output, something that QMS too, aspires for.

Perfection

The fifth and step of perfection is the most important principle of all. It casts the organisation into a culture of lean thinking and continuous process improvement as demanded from QMS. Employees are trained to strive towards imbibing the principle of quality in all their workplace tasks.

Conclusion

Both, Lean Manufacturing and QMS find a common ground in enunciating their core belief in quality standard for customer satisfaction. A synergy of the two would be phenomenally beneficial to all organisations.

Quality System in Pharma Manufacturing

What are the stages of implementing a Quality System in Pharma Manufacturing

Quality System in Pharma Manufacturing Like we have said before that Quality Management System in Pharmaceutical Manufacturing Industries is must have. In this Quality Systems management, there are different stages and necessity of each stage. These stages are independent and work as a benefit to the end product but severely interlinked with each other, that makes all the stages equally valid and important.

We will make you aware of the stages that serve mandatory in the implementation of Quality Systems in Pharma Manufacturing.

Let us talk in brief about the process and orientation of the available 9 stages, here.

Stage – 1

Generate templates for the controlled documents

All the templates must be written regarding all the controlling document types planned to be used. All these templates must contain consistent formats and styles which will make the documents very easy to navigate also to read.

Stage -2

Identify your company’s key processes, existing procedures, and management and control systems needed for the QMS.

Majority of the companies already bear written policies and procedures of some type. However, these procedures seem to be incomplete, if lacking out specific detail, it remained out of date, or if not merged with other business processes.

Stage – 3

Map the key processes and procedures so that their sequence and interaction is clear. Highlight any area that is missing a document that is required as part of the QMS.

To map the processes that are used to manage the quality structure, including the company’s own built sequence and communication with each other. Mapping simply looks similar to any flow chart. One must ensure that every stakeholder is engaged in this process; treat it as running a brainstorming session with multidisciplinary group members.

Stage – 4

Map needful document hierarchy structure with high level document contents for all types of controlled documents.

To organise the following document types:-

Procedures

Work Instructions

Forms

Lists

Quality Manuals

 

Quality System in Pharma Manufacturing

 

Stage – 5

Draft all the controlled documents upon the document maps.

All the controlled documents should be drafted according to the document maps. We must consider the root level audience for the document and make use of language and vocabulary that is both appropriate for the company and for the users.

Stage – 6

Manage electronic drafts and draft a Master Document List.

Companies suggest saving the files with a type of document identifier in the file name. This will ensure that versions and review moderation can be tracked and handled.

Stage – 7

Review the content of all QMS documents with subject matter experts (SMEs).

Be assured that all documents are investigated by subject matter experts (SMEs) from all the mandatory areas that are influenced by the extent of the record. Issuing a controlled document that influences any single area where staff have not had the chance to survey may cause superfluous contact, decrease consistency and increment the danger of deviation.

Stage – 8

Finalise the QMS documents for approval and issuing.

Plan printed copies of all documents, considered and acquire the suitable approval as managed by the compliance standard. Issued unique hardcopies must be documented in a safe area. Once the QMS documents are affirmed and are prepared to be actualized (issued), must save the electronic files as per your document control method utilizing the document correction number in the record name. Distribute the controlled documents (printed copy or pdf) as indicated by the document control strategy so staff can be prepared and utilize the documents.

Stage – 9

To go live! Train all staff on appropriate documents with respect to their training matrix.

This is when you should start your process of production after all the above steps have been implemented with the utmost details.

As you know that these methods are surely heavy to maintain and follow up. So it is considered to be more accurate if done using Quality Management System Softwares than doing these tasks manually.

Pharma 4.0 and impact in quality

Pharma 4.0 and impact in quality

Pharma 4.0 and impact in quality The vision for Industry 4.0 is to associate all assets like human, data, and physical machines and all in one virtual system. This network is both inside and beyond organization walls; the most of the advantage will be accomplished by exploring beyond plant walls.

Pharma 4.0 and impact in quality

Industry 4.0 joins different innovations, including huge data examination and cloud computing. The capacity to break down tremendous data volumes and offer knowledge over the virtual esteem bind will be imperative to conveying new innovation and reacting to changing market elements. Substance and data are put away in a managed cloud archive so data can be gotten to continuously from anyplace.

By applying the ideas of Industry 4.0 to the pharmaceutical industry, “Pharma 4.0” is both progressive and transformational from the outbound stream of merchandise to the data flow back of continuous patient data.

Industry 4.0 as the assembly of individuals, physical systems, and data inside a modern procedure to expand quality, profitability and benefit by utilizing the intensity of cutting-edge data investigation. Pharma 4.0 can be characterized similarly.

It is depending on two factors:-

  • The numbering system utilized in software advancement.
  • The possibility that the Mechanical Revolution, described by automation and steam control, was Industry 1.0; the entry of power was Industry 2.0; the Web was Industry 3.0, and we are currently in the early stages of Industry 4.0 that is Pharma 4.0.

 

Pharma 4.0 and impact in quality 1

 

Its Impact on quality management systems:-

The pattern towards more individualized therapies implies greater quality data to survey and more discharges to help. With this comes more stress on quality to abstain from being the bottleneck in a make-to-arrange world.

Acknowledgement of Pharma 4.0, is something that requires a move in how GxP content and data are overseen. The present methodology is still incredibly in view of paper and a conventional meaning of documentation needs. This backs off procedures and is constrained with regards to effective information sharing and joint effort over different gatherings.

 

Change needs to begin with changing the attitude and impression of GxP content:

  1. An electronic content isn’t simply ignoring paperwork – Numerous companies think they have cutting-edge execution systems, however, those systems still help paper-based preparing for GxP record-keeping. Looking forward, GxP-consistent documentation will emerge in new electronic arrangements, which can’t be legitimately made do with inheritance paper-based procedures.
  2. GxP and non-GxP data administration will consolidate – GxP importance to records and systems will be characterized by use, not physical partition like various paper or document duplicates. This implies grouping as GxP or non-GxP won’t be active any longer, and this requires security instruments and controls for non-GxP cases.
  3. Globally coordinated effort and substance trade are musts – The objective is never again to detach materials and data behind organization dividers, but instead to encourage a protected trade among a virtual group. Group set-up can change rapidly, and procedures may be reconfigured. So, it is essential to not just allow access to outside gatherings on a micro level, yet in addition to denying access in an adaptable and secure method.

The pattern towards customized treatments requires a change. One that backs the move from unyielding large-scale manufacturing to manufacturing separately custom-made items with the normal quality, safety and viability. A Pharma 4.0 methodology is expected to help this movement. Quality needs to order the evaluation of dangers and the execution of successful controls to open the ways to Pharma 4.0.

MAINTENANCE METRICS IN OEE

MAINTENANCE METRICS IN OEE

INTRODUCTION

MAINTENANCE METRICS IN OEE In the manufacturing sector, world-over, machines have overwhelmingly taken over the production of goods. Machines, as we all know, are subject to wear and tear, and if not repaired timely, eventually, break down. To address the issue of maintenance manufacturing firms would benefit by adopting TPM to monitor their machines’ performance and condition. The preventive metric of OEE can be used as a tool by the management and workers to continually assess how well machines are serving their owners, in real time, and determine action for repairs as and when required.

PREVENTIVE METRICS IN CONTEXT OF OEE

OEE or Overall Equipment Effectiveness, a performance metric quantifies the efficiency of machines. It brings to visibility the entire factory floor, along with the machines and the various production processes in the production lines. Before we set appreciate the implications of preventive metrics, let first understand how an OEE  system operates.

OEE provides digital data in the real time primarily by basing its calculation on 3 key elements of production :

  1. Availability = (Operating time – Downtime) /Total Operating Time
  2. Performance = Total output/potential output
  3. Quality = Good output/total output
OEE system

The TPM metrics is derived from the study and analysis of data provided by OEE on above 3 critical elements.

Advantages of the Preventive Metric

Reduces Downtime

One main feature of the OEE system that reflects TPM metrics is the Availability feature which captures Operating time, Downtime and Total Operating time. In the process, OEE helps in tracing a host of issues, including adverse machine conditions that cause downtime. The issues can be detected at the individual level, a cell or line level, or the whole plant level.

Tracing Equipment Fault in Real Time

The data provided by OEE reaches the minute levels of production processes, to show where a machine is at fault. Once fault is found, appropriate action can be taken, and thus, downtime be reduced. TPM metrics calls upon the unit to nip an equipment’s problem at the bud stage, so as to prevent problems from aggravating in the future.

Reduces Repair Costs

Preventive metrics drastically reduces your repair costs. Without OEE, the faults of the bigger and more complicated machines cannot easily be detected, more dso in real time. An interface of OEE with CMMS ( Computerised Maintenance Management System ) further aids the TPM system to take preventive measures promptly. Timely repairs could avert breakdowns causing downtime, and a significant loss for the firm.

The TPM metric could be checked from the Rate of Quality percentage as well. The rate gives comparative statistics on the acceptable parts produced versus the scrap. Since the preventive metric gathers data both at individual machine and line levels, it facilitates detection of faults at its root.

Case Study

The benefit of the application of maintenance metric can be seen in the case of GE Fanuc. The organisation had earlier sought to decrease its downtime duration by the use of engineering processes. It was successful in its endeavour, but not satisfactorily. Later when it switched over to OEE, GE application, the management detected plant’s bottleneck area – hundreds of brief line stoppages due to simple misalignment causing a dip in productivity were traced. Subsequently, when the firm took corrective measures, production spiked.

CONCLUSION

MAINTENANCE METRICS IN OEE When you have machines cranking out goods for your firm, don’t neglect their well-being. The solution indeed is to keep a quantified vigilance over their efficiency and productivity. And what better way to do so than using the maintenance metric under the arc of the OEE system.

 

Pharma Manufacturing

How to tackle warning letters in Pharma Manufacturing?

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.

 

Pharma Manufacturing

 

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:-

  1. Address every perception independently
  2. Recognize the issue
  3. Show a comprehension of the issue
  4. Assess the effect and decide the reason
  5. Depict rectification and precaution activities obviously and in a way that passes on comprehension of the issue and an exhaustive underlying driver investigation
  6. If possible, amend infringement promptly and tell in 483 response
  7. In the event that conceivable, give confirmation of these activities
  8. 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

Passing the IATF test

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 1

Discussing the Quality Metrics in Pharma System Implementation

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.

Discussing the Quality Metrics in Pharma System Implementation

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.

 

Discussing the Quality Metrics in Pharma System Implementation 1

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.

2

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

The Quality Metrics to Monitor in Manufacturing

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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