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Digg It - Adopting a Business Process Approach to Management - 6 Critical Steps
1. Determine Who Are Your Customers and Stakeholders, and What Benefits Your Organisation Offers Them
In our previous article we emphasised the customer/stakeholder focus of the business process approach to management. The first step is therefore clearly determining who those customers and stakeh
In our previous article we emphasised the customer/stakeholder focus of the business process approach to management. The first step is therefore clearly determining who those customers and stakeh
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
olders are. Who buys or uses your product or service offering? Who makes the buying decision? What exactly are they buying in terms of benefits? Who else is affected by your activities and what are their expectations?
A small pharmaceutical manufacturer of multivitamins, antibiotics, syrups and OTC medicine
A small pharmaceutical manufacturer of multivitamins, antibiotics, syrups and OTC medicine
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
for children, located in a large African city, was trying to answer these questions for their own organisation. They came up with the following.
Customer/Stakeholder and Benefits Sought Wholesalers: Availability, reliable delivery, favourable payment terms, margins, marketing support
Reta
Customer/Stakeholder and Benefits Sought
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
lers: Availability, quality, clear product information, price
Suppliers: Guaranteed business, prompt payment
Hospitals and HMOs: Quality, price
Doctors: Quality, efficacy, product information
Consumers: Price, efficacy, pleasant taste
Shareholders/bankers: ROI, growth
Regul
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
atory authority: Safety, quality, efficacy
2.Determine the Value Chains that Deliver these Benefits
The information obtained from the above step should be formed into benefit clusters. Next, trace those benefits back from your products and services through to the inputs. The identified paths form
2.Determine the Value Chains that Deliver these Benefits
The information obtained from the above step should be formed into benefit clusters. Next, trace those benefits back from your products and services through to the inputs. The identified paths form
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
your value chains or end to end core business processes.
Our pharmaceutical company took this step and concluded they had one major value chain consisting of two major processes - the new pharmaceuticals development process and the sales and production process.
All the benefits to the customers and other s
All the benefits to the customers and other s
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
akeholders are derivable from their product range, their distribution and market support and their information dissemination.
3. Decompose into Processes and Determine the Process Boundaries
The previous step yields an end-to-end view of the organisational value chains. We now need to determine
3. Decompose into Processes and Determine the Process Boundaries
The previous step yields an end-to-end view of the organisational value chains. We now need to determine
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
the core processes and sub-processes that make up these value chains, and the support processes that enable them. The determination of process boundaries should combine top-down and down-up approaches applied iteratively.
Listing out the major processes in the value chain as we did in the previous step, is t
Listing out the major processes in the value chain as we did in the previous step, is t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
p-down. We might then take each major process identified and using the following procedure suggested by Patrick and McDermott, break them down into sub processes.
Brainstorm the milestones or necessary results of the process
Link the milestones together, such that the output of one is the input of
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
the next
Note steps within one-to-one, one-to-many and many-to-one relationships from the above. Assemble all one-to-one steps to form the individual sub-processes within the major process.
In the case of the pharmaceutical for example, we might find, after going through this sequence that the sales an
In the case of the pharmaceutical for example, we might find, after going through this sequence that the sales an
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
production process decomposes into the customer acquisition (identify prospect, qualify prospect and establish contract) and order fulfilment (receive order, produce and assemble order, and ship order) sub-processes.
4. Select Appropriate Metrics Based on Critical Success Factors for the Identified Proce
4. Select Appropriate Metrics Based on Critical Success Factors for the Identified Proce
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
sses and Overall Strategy
It is well known that measurements and rewards drive behaviour. To ensure proper balance between focus on past/current performance, and the need to build capabilities that drive future success, we need metrics that track results, processes, organisational capability and the
It is well known that measurements and rewards drive behaviour. To ensure proper balance between focus on past/current performance, and the need to build capabilities that drive future success, we need metrics that track results, processes, organisational capability and the
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
nvironment.
Result measures are generally lagging in that they track past performance. By the time the result is measured, it is too late to do anything about it. Process measures are generally leading and prescriptive, since they predict future performance. Acting on factors that affect these measures will
Result measures are generally lagging in that they track past performance. By the time the result is measured, it is too late to do anything about it. Process measures are generally leading and prescriptive, since they predict future performance. Acting on factors that affect these measures will
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
mpact on future results. Care must be taken that metrics which drive the desired behaviour and customer valued outcomes are selected.
Having determined the critical factors that drive delivery of customer and stakeholder metrics or indicators of performance must be chosen, with targets for each measure, and
Having determined the critical factors that drive delivery of customer and stakeholder metrics or indicators of performance must be chosen, with targets for each measure, and
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
cascaded down to individual sub processes. A line of sight must exist between overall organisational measures and the detailed measures at process and activity level.
Our pharmaceutical company chose to measure four categories. At the top level, the chosen metrics were: Financial – ROI, earnings from n
Our pharmaceutical company chose to measure four categories. At the top level, the chosen metrics were:
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
w products
Customer/ consumer: Market share growth, price vs competition, value perception, on time delivery
Internal: Process improvement index, employee satisfaction index, environmental compliance index
Learning/growth: Number of patents, applied learning index
5. Appoint Process Owne
5. Appoint Process Owne
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
s for Each Core Process
A major flaw of the functional orientation is that there is no one within the organisation that has a complete view of the process as experienced by the customers and stakeholders. The appointment of process owners overcomes this flaw.
The job of process owner is to manage th
A major flaw of the functional orientation is that there is no one within the organisation that has a complete view of the process as experienced by the customers and stakeholders. The appointment of process owners overcomes this flaw.
The job of process owner is to manage th
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
e processes in the critical areas of improvement, boundary management, metrics, collaboration and advocacy. The process owner coordinates the functions and activities at all levels of the process, and has the authority and ability to makes changes to the process. He is responsible and accountable for its out
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
ome.
6. Begin a Never Ending Cycle of Business Process Improvement
With your core processes defined and documented, appropriate metrics selected and process owner appointed, the next step is to begin an improvement cycle.
Using process diagrams, value stream maps and metrics, determine the curre
6. Begin a Never Ending Cycle of Business Process Improvement
With your core processes defined and documented, appropriate metrics selected and process owner appointed, the next step is to begin an improvement cycle.
Using process diagrams, value stream maps and metrics, determine the curre
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
t capabilities of your core processes. Identify and quantify areas of greatest opportunity using information from customer surveys, comparison of your process performance with a similar ideal process, etc.
Continuous business process improvement is the subject of our next article. Be sure to watch out for it
Continuous business process improvement is the subject of our next article. Be sure to watch out for it
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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