This multi-part blog post series presents practical answers to frequently asked questions on improving business entities. 

Its objective is to assist business leaders in these trying times, whether they are learning the basics of business process improvement, planning their first business improvement project, or evangelizing process-oriented thinking throughout their organization.
 
So, let’s get started…

Often, CMMI is compared to ISO 9001, and rightly so since they are similar in terms of improving quality systems. However, CMMI aims to create a system that allows business process improvement through measuring and defining the various stages that are ‘to be used’, whereas ISO 9001 quality levels are less specific and easier to obtain.
 
As regards ISO Vs Six Sigma, a comparison is impossible since they perform quite different functions. ISO 9000 family indicates ‘what and how’ an organization will manage the quality of its products and services; while Six Sigma focuses on reducing or eliminating errors, variations, and increasing customer satisfaction’.
 
I shall discuss more FAQs concerning effective & efficient business process improvement in upcoming parts of this blog post series...
 
By the way, if you run a company that is facing a challenge to thrive in these difficult times, I would suggest that you please revisit your business processes in order to accelerate growth and bring a quick turnaround.

Keywords and Tags:

#businessprocessimprovement #ISO #SixSigma #CMMI #qualitymanagement #businessprocessmodification #businessprocessreengineering #processimprovement #continuousimprovement 

ISO and Kaizen are both time-tested continual improvement techniques. Both ISO and Kaizen can be used for continuous as well as continual improvement campaigns across all industry sectors. 

Both ISO and Kaizen bring-on organizational transformation and business growth. Therefore, the choice of selecting ISO or Kaizen or both, will depend upon the organization’s goals.

In this blogpost I shall touch upon the differences between ISO and Kaizen. By the way, when I mention ISO, I am referring to ISO 9000 series.
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Just as there are similarities between ISO and Kaizen, there are several stark differences too. I have enumerated few differences between ISO and Kaizen below. Make sure to take cognizance of them before initiating continuous improvement culture at your workplace.

To bring it all together, ISO certification builds credibility. It gives assurance to customers that the company meets a basic minimum criteria of quality standards. This can also help a company access new markets.
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Kaizen increases value a customer gets for his/her money. This increases sales as well as market share.  Moreover, Kaizen fundamentally improves the way a business operates which increases profit figures and EPS (earnings per share). Kaizen therefore directly increases a company’s top line as well as bottom line.

Further, Kaizen implementation is simple and easy. The small, incremental improvements done regularly via Kaizen bring-on exponential benefits. Kaizen is the method of choice to bring about quick organizational transformation.

Keywords and Tags-
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#continuousimprovement #ISO #Kaizen #businesstransfromation #qualitymanagementsystems #productquality #processcontrol #qualitycompliance #ISOcertification #differencebetweenISOandKaizen

​Return on pharmaceutical R&D investment is steadily dropping over the past decade from 10.1 % in 2010 to 1.8 % in 2019. 

Also, cost to bring a new product to market has increased by 67 % since 2010 according to a research study report published by a leading Management Consulting firm. 

This data needs a serious investigation into- How to arrest the ROI drop and more importantly, how to increase pharmaceutical R&D ROI?

A root cause analysis of this problem could show one or many cause(s), for example- low R&D productivity, poor infrastructure, ineffective workflows, inefficient processes, poor decision-making, increased number of generic players, time taken for drug discovery thru product launch in market is higher than planned, higher number of clinical trial failures, changing patient needs, etc.

Regardless of the cause(s) of the problem(s), a sure way to increase ROI is to introduce a culture of continuous improvement in the R&D department later expanding across the entire organization.

There are more than eighteen scientific and proven continuous improvement methodologies which can be implemented in pharma R&Ds and across the organization. Some of the popular ones being Lean Six Sigma, ISO, TRIZ, Hoshin, Kaizen etc. You can know more about different continuous improvement methodologies here.

Note that continuous improvement initiatives must be customized for each company in order for it to be effective. So, a natural question that pops up is- How to start continuous improvement campaign at the R&D workplace? This is a vast topic and can run into several pages, but I shall touch upon it briefly here.

How to start Continuous Improvement campaign in pharma R&D?

Continuous Improvement initiatives must be customized for every company. A continuous improvement technique found successful at company A may not produce equally good results at company B, despite the two companies belonging to the same industry vertical.

The choice of continuous improvement methodology depends on the organizational size, culture, set of problems, product mix, financial status etc. You can know more about how to choose a continuous improvement methodology for your organization here.

Here are 9 easy steps to follow in order to initiate continuous improvement at your R&D site-

1. Customize ROI data for your organization- Plot a graph of return on your R&D investments for the past decade.
2. Map processes. Build Swimlanes.
3. Build strategy road map for your continuous improvement campaign. Identify teams and key players.
4. Conduct a Root Cause Analysis of the ROI data and R&D processes to identify root cause(s) of the problem.
5. Run Kaizen Events to find potential solutions.
6. Apply solutions and monitor results.
7. Standardize processes.
8. Improve continuously.
9. Celebrate success!

Tip: Use appropriate continuous improvement tools judiciously at each of the above steps to take smart decisions from time to time.

​Note that after strategy, a significant success with continuous improvement campaigns is achieved by using the right tool at the right time. There are over hundred proven Continuous Improvement tools to work with. You can check out more on Continuous Improvement tools here.

A PDCA (Plan-Do-Check-Act) cycle is extremely helpful to ensure rapid success with continuous improvement initiatives.

A common question I get while leading continuous improvement projects is- Our company is ISO certified. Do we still need to go for Kaizen?

And my response to that query is- Yes definitely. The reason being ISO methodology focuses on ‘control of processes’ underlying quality and compliance to standards. While Kaizen focuses on ‘improvement of processes’ not just quality processes but ALL processes including technical and business processes.

Having ISO and not running Kaizen along with it is like eating only a part of the pie. In fact, I would say, in order to get the maximum benefits from ISO certification, practice Kaizen.

Just 15 minutes of daily Kaizen brings stupendous rewards. I have a separate blogpost describing difference between ISO and Kaizen. You may want to check it out here.

Kaizen is a Japanese technique of process improvement. Kaizen implementation does not need big budgets and also it is super effective.  You can check more about Kaizen for pharmaceutical, medical device and biotech industries here.
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Are you planning to start a culture of Continuous Improvement for your workplace?

This multi-part blog post series presents practical answers to frequently asked questions on improving business entities. 

Its objective is to assist business leaders in these trying times, whether they are learning the basics of continuous improvement, planning their first business improvement project, or evangelizing process-oriented thinking throughout their organization.

We are in year 2021, yet, for the benefit of professionals who have just recently started out on business process improvement journey, I have included this FAQ on ISO 9001:2015.

Note: ISO 9001 is usually updated every five years. It was last updated in September 2015, hence it's referred to as ISO 9001: 2015. Therefore, until further update is announced, ISO 9001: 2015 is the current ISO 9001 standard.
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So let’s get started…

​The ISO 9001:2015 features two important changes, both in content and structure.
 
Firstly, ISO 9001:2015 describes more about processes (especially ‘non-conforming’ processes), process ownership and accountability. A clear definition of process enables better monitoring; better analysis and improvement actions tend to be more effective.
 
Although, this will require organizations to monitor processes and evaluate when they are non-conformant to specifications or user needs. This will also require (as appropriate) an investigation into the causes and taking action to prevent recurrence of the detected problems. Alternately, ISO 9001:2015 brings forth stringent supplier quality control.
 
Secondly, it puts ‘risk management’ as one of the focal points of organization’s attention. This is blessing to organizations in aerospace - that currently need to be AS9100 compliant and use the CMMI as a model for process improvement. The ISO-based standards are catching up with the ‘process’ focus that has always been integral to CMMI adoption.
 
ISO 9001:2015 is a positive move and smart organizations will be able to better leverage their investments in both ISO and the CMMI. Integration among all standards is one of many reasons for ISO revision.
 
ISO 9001:2015 prescribes risk-based management techniques and emphasizes on preventive actions. It not only works to assess risk to the company and to its customer, it also attempts to be supportive of service industries, office environments, virtual offices that have found ISO standard difficult to implement in the past.

You can read more about ISO methodology, advantages of ISO and limitations of ISO here.
 
I shall discuss more FAQs concerning effective & efficient business process improvement in upcoming parts of this blog post series. If you have any such questions about business process design or continuous improvement, please feel free to drop it in the comment section below.
 
By the way, if you run a company that is facing a challenge to thrive in these difficult times, I would suggest that you please revisit your business processes in order to accelerate growth and bring a quick turnaround.

This multi-part blog article presents practical answers to frequently asked questions on improving business entities. 

Its objective is to assist business leaders in these trying times, whether they are learning the basics of continuous improvement, planning their first business improvement project, or evangelizing process-oriented thinking throughout their organization.
​
So let’s get started…

The ISO approach is vital for businesses and organizations to strive and develop a good reputation, as well as, to excel in future aspirations of the company. However, there are some limitations, which can make it difficult to use ISO approach for quality management and continuous improvement.
 
One of the limitations with the ISO for quality is that it does not have much weight when it comes to an individual’s performance in a company. Individuals are not required to be responsible for their unique contributions since, the company’s effectiveness is viewed as a whole. It can often be quite motivating and more effective for a company to allow individuals to take responsibility for their contributions.
 
This also helps increase employee self-esteem and integrity, which can make them work harder for the company and produce effective results. Another way in which individual assessment is beneficial is that it encourages interest and concern within the company. Therefore, one needs to take appropriate steps in order to maintain employee morale during and after implementation of ISO.
 
Since individual contributions are not monitored closely, ISO can also take a lot of time to find the root cause, should a problem occur.
 
Secondly, ISO approach can waste a lot of money. ISO often encourages companies to scrap any defaults or defective produce altogether. This is fine if all produce is perfect, but it is quite common to have few of products that are defective and not the whole lot.
 
In addition, this is very subjective as ‘defects’ can also be classified as- critical, major, minor etc.
 
Moreover, it is industry based. For e.g. in pharmaceutical industry, even a minor product defect is not acceptable since it would potentially compromise safety and/or efficacy to the patient. While, in a packaged food industry, dented cans (containing quality product) is many a times classified as ‘minor’ defect, not scrapped, and instead sold at a discounted price.
 
If the goal of the company is to be ‘defect-free’ or supplying only ‘high quality’ products, then ISO can end up costing the company quite a big chunk of money, in case of product/service defects. Strategic financial planning, considering this ‘all or none’ aspect, becomes vital before selecting ISO methodology for your organization.
 
ISO approach relies almost completely on presenting documentation that depict the system’s various procedures, which can be very time consuming and cause a company to loose focus of their business goals in the meantime.
 
Since those running/ managing/ leading the company, are in charge of arranging the documentation, the time spent gathering this information can take away their contributions to their routine job during that time. Companies therefore need to be up to date with their human resource planning prior to embarking on ISO journey.

You can read more about ISO methodology, advantages of ISO and limitations of ISO here.

I shall discuss more FAQs concerning effective & efficient business process improvement in upcoming parts of this blog post series. If you have any such questions about business process design or continuous improvement, please feel free to drop it in the comment section below.
 
By the way, if you run a company that is facing a challenge to thrive in these difficult times, I would suggest that you please revisit your business processes in order to accelerate growth and bring a quick turnaround.

Keywords and Tags:

#businessprocessimprovement #continuousimprovement #ISO #qualitymanagement #businessprocessmodification #businessprocessreengineering  #processimprovement  

This multi-part blog post series presents practical answers to frequently asked questions on improving business entities. 

Its objective is to assist business leaders in these trying times, whether they are learning the basics of business process improvement, planning their first business improvement project, or evangelizing process-oriented thinking throughout their organization.
​
So let’s get started…

​CMMI or Capability Maturity Model Integration is indeed, one of the most popular business improvement methodology within the IT sector, also within the aerospace industry.
 
CMMI has many advantages when it comes to implementing the methodology to an organization, whether in the organization’s entirety or in departments. However, there are some limitations worth noting before incorporating this methodology.
 
CMMI is not exactly designed to suit every organization. There are times when using CMMI will not enhance existing performances, due to the strict documentation requirements that are necessary to implement this methodology. This is unachievable for many companies, especially of smaller size.
 
In addition, CMMI requires a detailed process that lists all the stages. It is better for bigger businesses to use CMMI than smaller ones since, smaller businesses often do not have the adequate resources or data to fulfill the requirements of CMMI methodology.
 
CMMI methodology demands a large amount of effort and time to put the changes into action. It also requires a significant shift in the mindset and philosophy of the organization, which can be quite stressful and overwhelming if the introduction of the ideas of CMMI is not successful.
 
Moreover, a business’s work culture can change drastically by implementing strict administration of CMMI. This can lower the feeling of independence and creativity amongst employees or developers.
 
Further, the models used in CMMI are not processes in their own right and do not offer the expected descriptions. Organizations have a right to choose the processes depending on the factors that are important to the business and it can be difficult for organizations to choose the best method. Despite being easy to understand, the various techniques used by CMMI can actually be difficult to implement.
 
Yet another reason CMMI can be limiting to a company is because, it draws the focus of the organization to reaching each level as a ‘goal’. Therefore, each minor goal is constantly being pursued and efforts get drawn away from the bigger picture i.e. business process improvement itself.
 
Moreover, using CMMI does not mean that success will definitely be achieved, since each organization needs to adapt the various stages in order to fulfill their own unique needs.
 
I shall discuss more FAQs concerning effective & efficient business process improvement in upcoming parts of this blog post series. If you have any such questions about business process design or continuous improvement, please feel free to drop it in the comment section below.
 
By the way, if you run a company that is facing a challenge to thrive in these difficult times, I would suggest that you please revisit your business processes in order to accelerate growth and bring a quick turnaround.

This multi-part blog article presents practical answers to frequently asked questions on improving business entities. ​

Its objective is to assist business leaders in these trying times, whether they are learning the basics of continuous improvement, planning their first business improvement project, or evangelizing process-oriented thinking throughout their organization.

So, let’s get started … 

It is no secret that the internet plays a vital role in many businesses. Business interactions become quicker, easier through the internet and allow handling of business relationships/ transactions in many ways.
 
E-business describes the combination of an organization’s informative and communicative tools, technologies, otherwise known as “business software”. It allows for the improvement of processes by creating more value to the organization, clients and associates.
 
E-business process improvement is not only applicable to companies that exists virtually, but it can be applied to all types of businesses that use IT or work with digital products. The desired result of e-business process improvement is to complete processes in a quicker manner, while spending less funds and adding value to the company.
 
E-business process improvement is a vital part of e-continuous improvement program.
 
E- business process improvement enhances the workflow in a company effectively and efficiently. Also, it allows large and fast changes to take place which are essential for e-businesses, since they are always changing and expanding. Organizations must integrate their e-business processes with best-in-class process improvement methodologies in order to reach their goals.
 
The outcome of adopting e-business process improvement program in an organization is to generate value. Often, creating value brings forth an increase in employee motivation, customer satisfaction, a rise in profit margins and favored affiliations with associates.
 
E-business process improvement campaigns also aim to lower the mistakes caused by individuals because of misunderstandings or miscommunications, while motivating employees.
 
It is a common belief that executing e-business process improvement requires high-level technology. While high-level technology can help, it is definitely not the only way that implementation can and will take place.
 
E-business process improvement requires both the IT and managerial departments to work together in order to come up with decisive ways in which, e-business processes of the organization are made to work more efficiently and effectively.
 
Some of the proven e-business process improvement methodologies are Lean, CMMI, Hoshin, Scrum, Agile, Kanban etc.
 
Be it a brick and mortar workplace or an e-business, both need to stay in business to sustain and grow. The problems faced by brick & mortar and e- businesses are not same, but there are quite a few ‘similar’ problems. Therefore, e- continuous improvement methodologies must be appropriately selected, enforced, monitored and continued for business efficiency, sustained growth and consistent increasing profits.
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I shall discuss more FAQs concerning effective & efficient business process improvement in the upcoming posts. If you have any such questions about business process design or continuous improvement, please feel free to drop it in the comment section below.
 
By the way, if you run a company that is facing a challenge to thrive in these difficult times, I would suggest that you please revisit your business processes in order to accelerate growth and bring a quick turnaround.

Keywords and Tags-
 
#businessprocessimprovement #ebusinessprocessimprovement #cmmi  #businessprocessmodification #processimprovement #continuousimprovementfor IT #continuousimprovementforebusiness