Monday, February 12, 2018

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Tuesday, March 5, 2013

Risk Management

Risk Management is the process of measuring, or assessing risk and developing strategies to manage it. Strategies include transferring the risk to another party, avoiding the risk, reducing the negative effect of the risk, and accepting some or all of the consequences of a particular risk. Traditional risk management focuses on risks stemming from physical or legal causes.

Financial risk management, on the other hand, focuses on risks that can be managed using traded financial instruments. Regardless of the type of risk management, all large corporations have risk management teams and small groups and corporations practice informal, if not formal, risk management.

An ideal risk management starts with establishing the context, inclusive of the identity and objectives of stakeholders, the basis upon which risks will be evaluated and defining a framework for the process, and agenda for identification and analysis. The next step in the process is to identify potential risks--events that, when triggered, cause problems.

Risk Management

Hence, risk identification can start with the source of problems, or with the problem itself. Once identified, they must then be assessed as to their potential severity of loss and to the probability of occurrence. After which, a decision on the combination of methods to be used for each risk shall be made. Each risk management decision should be recorded and approved by the appropriate level of management.

In as much as no initial risk management plans will be perfect practice, experience, and actual loss results will necessitate changes in the plan and contribute information to allow possible different decisions to be made in dealing with the risks being faced. In the end, risk analysis results and management plans should be reviewed, evaluated, and updated periodically.

Risk management also faces difficulties in allocating resources. This is the idea of opportunity cost. Resources spent on risk management could have been spent on more profitable activities. Again, ideal risk management minimizes spending while maximizing the reduction of the negative effects of risks.

If risks are improperly assessed and prioritized, time can be wasted in dealing with risk of losses that are not likely to occur. Spending too much time assessing and managing unlikely risks can divert resources that could be used more profitably. Unlikely events do occur but if the risk is unlikely enough to occur it may be better to simply retain the risk and deal with the result if the loss does in fact occur.

Prioritizing too highly the risk management processes could keep an organization from ever completing a project or even getting started. This is especially true if other work is suspended until the risk management process is considered complete.

Risk management is simply a practice of systematically diagnosing, quantifying severity, selecting cost effective approaches for minimizing the effect of threat realization of the risks to the organization. All risks can never be fully avoided or mitigated simply because of financial and practical limitations. Therefore all organizations have to accept some level of residual risks.

Copyright 2007 Ismael D. Tabije

Risk Management
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Monday, February 25, 2013

Business Process Management and Six Sigma: Why Neither Can Stand Alone

What is Business Process Management (BPM)?

BPM is a comprehensive methodology that helps design and maintains all aspects of an organization with the sole purpose of meeting and/or exceeding their customer's wants and needs both effectively and efficiently. BPM attempts to continuously improve the business processes either in incremental steps or with radical changes. One way or the other, such ambitious endeavors requires equipping BPM practitioners with powerful computerized tools and an overarching infrastructure to enable a wide range of problem solving solutions. BPM tools can be classified in four groups:

(a) Strategy - utilizing tools like environmental influence and goal models, problem and opportunities models;
(b) Analysis - using tools like business interaction models, organization and communication models, and process simulation;
(c) Design - workflow and process models, use case and event models; (d) Implementation / Execution - creating sequence and operation models, business classes and system models.

Business Process Management and Six Sigma: Why Neither Can Stand Alone

BPM is a combination of these tools (and some more) helping the business to document, understand, measure and improve their business processes. BPM help to create well documented and streamlined processes, which are essential to ensure consistency, traceability and focus towards shared strategy and performance goals.

What is Lean Six Sigma (SS)?

Six Sigma (or its newer offspring Lean Six Sigma, LSS) is also a comprehensive and highly disciplined methodology that helps us focus on developing and delivering near-perfect products and services, by analyzing the underlying business processes and preventing and / or removing defects before reaching the customer. LSS also is a wide range tool set that is used under organized the following "problem- solving" cuasi sequential steps:

(a) Define -some of the deliverables in this step are project charters, CTQs, house of quality, Kano models;
(b) Measure - statistical descriptive and graphical tools, process and value stream mapping, capability analysis, data gathering tools;
(c) Analyze -statistical analysis tools, brainstorming, Pugh matrices, House of Quality (QFD),FMEA, Muda;
(d) Improve - Pugh matrices, mistake proofing, 5S, design of experiments; (e) Control - Process Control plans and Statistical Process Control (SPC).

Given the different origins, skill sets and backgrounds of a "typical" BPM and "typical" Lean Six Sigma practitioner, there are some deployment facts working against both methodologies:

1. Lack of knowledge of each other: Most BPM teams and BPM Software Companies know very little about Lean Six Sigma and vice versa. BPM traditionally has been used and deployed as an information technology effort. LSS has been viewed as an operational tool for manufacturing and / or back office processes, not software development.

2. BPM is almost all the time accompanied by an enterprise-wide software tool, and requires a software vendor on a periodical basis for training, new releases, technical support, etc.

3. BPM is usually deployed as a technology management direction or from higher up management levels. 4. Six Sigma and Lean have been for the most part manufacturing efforts; and most recently operations management directives. As a foot note, some of the most successful Six Sigma deployments were executive management mandates (Motorola, Allied, Bank of America, to mention a few).

5. Six Sigma tools do not have a large technology foot print, with software requirements mostly at some of the organization's desktops. Its deployment is typically driven at the beginning by consulting organizations and then passes to internal resources (a Program Office is a typical modus operandi).

6. Neither BPM nor Lean Six Sigma specialist is traditional a Change and Integration Management expert or trained specialist. This knowledge vacuum causes hiccups in the deployment and acceptance of either methodology by the stakeholders.

7. Neither BPM nor Six Sigma have an integrated data collection tool, creating always a delay in data gathering which hampers a quick deployment and execution. Both rely on a third party layer to perform data gathering and data readying for analysis.

What does BPM lack?

BPM tools are very effective in creating business interactions and communications models, mapping processes and workflows, as well as capturing key metrics and resources relevant to those processes. However, many BPM teams struggle to understand which processes are the top priority for the business and which defects are the most critical to solve for any given process. BPM lacks of quantitative ranking methods and statistical tools to prove significance. Teams sometimes use a series of "hunches" and past experiences to decide how prioritize design and implementation strategies for new or improved processes. LSS has much to offer BPM teams in this area - through tools like Failure Mode Effect Analysis (FMEA), risk prioritization index and Value Stream Mapping (VSM). So, conceptually, BPM and LSS should be a great fit.

BPM is also a thin methodology to monitor the sustainability of any process change after implementation of such changes. Once process changes have been deployed, a project is closed and the consultant systems analyst goes home, or starts a new project. Tools like statistical process control and non-existent in the BPM tool set, leaving the operational leadership with (maybe) a wealth of reports, at best real-time. LSS offers via SPC, a wealth of proven and robust tools specifically tailored to particular quantitative variables; designed to monitor stability, trending and within control operational status.

BPM tools allows for storage of key data and key metrics for the different artifacts that are created and used in a project. However, does not allow for a strong statistical analysis of the data. As a matter of fact, most of the BPM data stores are for simple figures (like an average), curtailing itself for a more accurate data analysis, like hypothesis testing or a regression model to forecast future process performance. And the few software tools equipped with discrete or Monte Carlo simulators are rarely deployed.

What does Six Sigma lack?

By definition and key to its success, LSS tackles specific defects in a specific set of operations within a specific business process. This approach is very effective in eliminating defects. However, in general LSS lacks of a wealth of enterprise-wide view of the organization strategy, objective and goals, its actors and the organization surroundings. This is an area where BPM has a very strong showing. So, conceptually, BPM and LSS should be a great fit.

Lean Six Sigma also falls short when tries to incorporate tools for computer automation and information technology designs (both vital is most of our business processes with high integration and automation). BPM lends a helpful hand with use cases, event modeling, business class models, subtype and package models. Conceptually, again BPM and LSS should be a great fit.

It becomes very apparent that Six Sigma Lean and Business Process Management (BPM) neither can stand alone. Organizations that master the integration of both will have a higher rate of financial success when designing and implementing process to take any organization for a closer level of customer satisfaction and global competition.

What both methodologies lack?

BPM or LSS do not consider Change nor Integration Management or any of its derivatives when communicating changes to their stakeholders and much less to their customers. These important aspects of buying into the changes and managing smooth transitions and changes are not considered at all in any project plan, or are left to the assumed knowledge of the project manager.

The last section of this paper will present actionable tips to both BPM and Six Sigma practitioners to counter any natural resistance to change that will typically emerge from any organization when facing changes.

Core Reasons why companies don't want to implement BPM

In our experience these are the top reasons as of why there is no need for a formal BPM approach to process problem solving:

1. We have so much low hanging fruit that we know already what to do and where to start, we don't need a Business Process Architecture
2. Mapping out Processes slow things down, and is really over engineering our processes
3. We need savings now and don't have time to map out all of our processes
4. Why don't we just work on Process Control?
5. We don't know how to do Process Owners but we know how to improve processes, we've improved them before, and we can do it again.

If you are a Six Sigma Lean Resource and want a rapid tip to overcome BPM Resistance

- One can help frame Six Sigma DMAIC project or initiatives in the larger organization strategy context by quickly leveraging BPM's communication models, opportunity models, business interaction models, etc. as part of the analysis phase of DMAIC.

- BPM tools with the appropriate team of analysts and subject matter experts can create process maps and workflows in working sessions on average under one day of duration.

- Business Interaction Models show more strategic views than the conventional process model utilized in LSS.

- Opportunity models are a powerful tool to quickly establish and detect any missing component or gaps in the deployment of multiple DMAIV projects.

- At Metaspire, we develop current and future Business Interaction Models (BIMs) to scope the work for the current organization leading to the future BIM indicating how the various elements of the organization would interact in the future. Without these BIMs, we have seen duplication of efforts and the change one department was hoping for, quickly becomes undone by another department or conflicting priorities or initiatives.

Core Reasons why companies don't want to implement Lean SS

During our consulting activities some of the reasons as of why there is no need for a LSS implementation:

1. Didn't Six Sigma bring down Motorola and became non-competitive - too cumbersome
2. Six Sigma has little to offer and the tools and methods can be found elsewhere
3. Six Sigma stifles creativity and innovation
4. It's too expensive and too slow to implement
5. Too much specialized training and high maintenance of the six sigma group
6. Sounds to me like it would introduce too much bureaucracy
7. I don't understand why I need it in the first place

If you are a Process Improvement Resource and want a rapid tip to overcome Lean SS Resistance

- Motorola's Six Sigma methodology has now reached what internally is called Second Generation Motorola Six Sigma, with a process for governance, moving the tool from counting defects in manufacturing processes to an overall business improvement methodology, and in 2006 started Motorola Lean transformation and Software Design for Six Sigma. Thereby integrating Six Sigma tools with Business Process Management mindset.

- It is true that Six Sigma have incorporated tools that have been useful in previous quality initiatives (nothing wrong with that). However, the older methods do not magnify the impact of defects using millions of opportunities as a measure of quality, nor move from the traditional three-sigma to our six-sigma as a goal of perfection. Under Six Sigma, defect and defectives counts provide tangible, measurable results that we can use. Rather than being too costly, Six Sigma detractors are very unaware or ignorant of the cost of poor quality (COPQ) in their organizations. They have no baseline, and therefore any number is a high figure. A well-documented fact is that average companies perform at a 3 to 3.5 sigma level, with a COPQ ranging between 24% - 40% of their sales. Companies performing at a 5 sigma level lower their COPQ between 5% - 10% of their sales.

- Six Sigma consultants can bring the expertise for a quick proof of concept of LSS effectiveness within the organization. They will help to determine and prioritize any apparent low hanging fruits.

- Six Sigma is a business process improvement methodology, and unless deployed within a BPM architecture, has a hard time supporting strategic decision making. We can have a near perfection, defect free process producing Chocolate Cupcakes, and still the company will go down as the horse Chocolate Cupcakes market vanishes (God Forbid!).

- Best approaches to LSS deployment happens when the operations staff -project managers, supervisors, managers, directors are the six sigma practitioners. They continue to perform their traditional job related functions, but now they have a quantitative and statistical thinking and they decisions are supported with data facts.

- Often times, companies have a multitude of disparate measures and metrics. The Lean SS tool "House of Quality", helps companies focus on identifying customer requirements, where improvement is needed to meet or leapfrog competition, and strategies for making those improvements. As a result of this exercise core customer process measures and metrics are identified and can be re-weighted with a higher significance or introduced to the company.

- Why use Six Sigma at all? Most companies gather data and perform statistical analysis and forecasting of some sort, why not use statistically significant tools from Six Sigma to outperform your competitors? Six Sigma tools answer questions like: How do I know that I am measuring the right thing? How do I know that we are satisfying Customers and Shareholders? How can I measure and report the right processes? How do I stop defects before they occur? Six Sigma offers 10-12 tools where you can pick the right tools for the right question.

To summarize, BPM assists with organizational strategy whereas LSS assists with tactical improvement; and the most of the times forgotten Change Management component helps with the education, organizational development, integration and sustainability to operationalize changes.

Metaspire Approach Metaspire leads clients through an objective facilitation process. As a result our clients will not only have an aligned view on the low hanging fruit definitions, we also help the group align on priorities.

Do you need help with Six Sigma Lean, Business Process Management or Change Management?

We can help trim processes, control costs and improve profitability and operationalize changes.

Business Process Management and Six Sigma: Why Neither Can Stand Alone
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Nina Segura B.S., M.A., CSSBB
Metaspire Consulting - "Performance improvement from strategy to execution."
Web: http://www.metaspireconsulting.com/
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"I think a major act of leadership right now, call it a radical act, is to create the places and processes so people can actually learn together, using our experiences." Margaret J. Wheatley

Tuesday, February 19, 2013

An Over-view of Credit Risk Management in the Banking Sector

Over the years, banks have been involved in a process of upgrading their risk management capabilities. In doing so, the most important part of upgrading has been the development of the methodologies, with introduction of more rigorous control practices, in measuring and managing risk. However, the by far the biggest risk faced by the banks today, remains to be the credit risk, a risk evolved through the dealings of the banks with their customers or counterparties. To site few examples, between the late 1980's and early 1990's, banks in Australia have had aggregate loan losses of billion. In 1992, the banking sector experienced the first ever negative return on equity, which this has never happened before. There have been many other banks in the industrial countries, where losses reached unprecedented levels.

The analysis of credit risk was limited to reviews of individual loans, which the banks kept in their books to maturity. The banks have stride hard to manage credit risk until early 1990s. The credit risk management today, involves both, loan reviews and portfolio analysis. With the advent of new technologies for buying and selling risks, the banks have taken a course away from the traditional book-and-hold lending practice. This has been done in favour of a wider and active strategy that requires the banks to analyse the risk in the best mix of assets in the existing credit environment, market conditions, and business opportunities. The banks have now found an opportunity to manage portfolio concentrations, maturities, and loan sizes, eliminating handling of the problem assets before they start making losses.

With the increased availability of financial instruments and activities, such as, loan syndications, loan trading, credit derivatives, and creating securities, backed by pools of assets (securitisation), the banks, importantly, can be more active in management of risk. As an example, activities on trading in credit derivatives (example - credit default swap) has grown exceptionally over the last ten years, and presently stands at trillion, in notional terns. As it stands now, the notional value of the credit default swap (a swap designed to transfer the credit exposure of fixed income products between parties) on many established corporate, exceeds the value of trading in the primary debt securities, received from the same corporate. Loan syndications grew from 0 billion to more than .5 trillion between 1990 and 2005, and the same period saw a growth of loan trading, which grew from less than billion to more than 0 billion. For the banks, securities pooled and reconstituted from loans or other credit exposures (asset-backed securitisation), provided the means to reduce credit risk in their portfolios. This could be made possible by the sale of loans in the capital market. This became especially viable in case of loans on homes and commercial real estate.

An Over-view of Credit Risk Management in the Banking Sector

The banks are now more equipped in handling credit risk, in the allocation of its on-going credit allocation activities. Some of the banks use a more comprehensive credit risk management system, by critically analysing the credits, considering both, the probability of default and the expected loss in the possibility of a default. More sophisticated banks use the criteria given in Basel II accord in determining credit risk. In here the banks take credit decisions by increased expert judgment, using quantitative, model-based techniques. Banks, which used to sanction credits to individuals relying mainly on the personal judgment of the loan sanctioning officers, now use a more advanced method of srutinisation, applying the statistical model to data, such as credit scores of that individual. The lending activity of a bank has its credit risk invariably embedded, as one finds in the market risk. It all such cases, banks need to monitor risks by managing it efficiently, absorbing the risk involved.

Pricings of relevant risks are needed when-ever a bank moves in a lending contract with a corporate borrower. New analytical tools now enable banking organizations to quantify lending risks more precisely. Through these tools, banks can estimate the measure of risk that it is taking on the fund, in order to earn its risk-adjusted return on capital. This allows the bank to price the risk before originating the loan. Banks often use internal debt rating, or third party systems, that uses market data to evaluate the measure of risk involved, when lending to corporate issuing stocks.

The financial Pundits of the banking sector have discussed diverse range of subjects and issues, and have arrived on four main themes for a better credit risk management.

The first theme is concerned with a rapid evolution of techniques to manage credit risk. This evolution of techniques have been greatly supported by the technological advancement made, with low cost computing being made available, making analyzing, measuring, and controlling credit risk in a far better way. This has allowed introducing a more rigorous credit risk management system. However, despite the thoughts of the utilization of the techniques evolved, implementation of these practices still has a long way to go for the bulk of the banks. However, it is expected that the pace at which the changes are required to be introduced, will soon accelerate. With competition growing in the provision of financial services, there is a need for the banking and financial institutions to identify new and profitable business opportunities, and as such, it is inevitable that the policies on credit management have to change.

The second theme considered that, the ability to measure, control, and manage credit risk, is likely to be the criteria as to how the banking sector grows in the future. Widespread cross-subsidization has introduced significant negative impact on the net interest margin of all the banks, with a profitable business supporting the cause of otherwise non-profitable activities. The matter of cross-subsidization has been an intentional business decision by the management of the institutions. However, this has introduced problems in cash flow, with the inability to accurately measure risk and return. With the banks getting on to improve on their ability to measure risk and return on the activities, it is inevitable that the characteristic of the internal subsidies will become clearer.

The third theme considered the interaction between the management and the improved credit risk measurement. The theme also looked into the possibility of using alternative risk measurement techniques within the regulatory environment. There were certain issues that emerged.

1. The role of the supervision of a bank or a financial institution, in a more competitive and a much more advanced financial environment.

2. At what extent are the banks' risk supervisory efforts and their relevant policies, keeping pace with the initiatives and developments taking place in the market.

3. The urgent need to align the supervisory methodologies conceived, with the newly emerging risk measurement practices. In this issue, a general sense of optimism exists, where the alignment between the banking sector and the regulatory authority, regarding the approached towards the risk management practices, would happen over time. However, there is an obstacle in meeting the objective. The banks need to demonstrate with confidence, that they have in place well defined, and well tested rigorous risk management models, which are completely integrated into their operational system.

The fourth and the last theme that evolved, was the need to have a firm commitment from the banking sector, relating to the management of risks in all its forms, and the need to have a strong orientation of the credit management policy embedded within the culture of banking. Without such a firm commitment coming from the higher levels in the banking sector, the alignment between the regulatory authorities and the banking institution, relating to strong credit management principles, is hard to achieve. It needs to be mentioned here that, today, unless banking institutions do not take a firm committed step towards a viable credit management system, and integrate the policies within their operational culture, it will be difficult for the sector to meet any broader objective, which importantly includes improved shareholder returns.

In the matter to be better aligned, there is a necessity of accurate measure of the credit risk involved in any transaction that the bank makes, and such a measure is bound to alter the risk-taking behavior, both, at the individual and at the institutional levels within the bank. So long we have been talking about the state-of-the-art technology and its use in rigorous credit risk modeling. With this, it should be borne in mind that, improved measurement techniques are not automatically evolved without the application of proper judgment and experience; where-ever credit or other forms of risks are involved.

prabirsenuk@yahoo.co.uk

An Over-view of Credit Risk Management in the Banking Sector
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Over twenty two years experience in Oracle. Significant development & Management skills viz.,technical writing, project planning and execution, project management, Oracle sql, pl/sql, data flow design, database design, datawarehousing, Oracle applications viz., manufacturing, scm, crm, financials, hrms,workflow, Oracle discoverer, forms, reports, etc., having expertise in Business Analysis. Presently a Sr. Program Manager with a Large IT organization in London, looking after 10 Oracle applications project in Europe, and managing offshore development partners.

Education:

1. Fellow - Institute of Electronics & Communication Engineers.
2. MSc. Eng (Computer Science), University of London.
3. BSc. Eng (Electronics), University of London.

Hobby: Writing

prabirsenuk@yahoo.co.uk

Saturday, February 9, 2013

A Standard Procedure For Quality Assurance Deviation Management

What is a Deviation:

A Deviation is a departure from standard procedures or specifications resulting in non-conforming material and/or processes or where there have been unusual or unexplained events which have the potential to impact on product quality, system integrity or personal safety. For compliance to GMP and the sake of continuous improvement, these deviations are recorded in the form of Deviation Report (DR).

Types of Deviations:

A Standard Procedure For Quality Assurance Deviation Management

1. Following are some examples of deviations raised from different functional areas of business:
2. Production Deviation - usually raised during the manufacture of a batch production.
3. EHS Deviation - raised due to an environmental, health and safety hazards.
4. Quality Improvement Deviation - may be raised if a potential weakness has been identified and the implementation will require project approval.
5. Audit Deviation - raised to flag non-conformance identified during internal, external, supplier or corporate audits.
6. Customer Service Deviation - raised to track implementation measures related to customer complaints.
7. Technical Deviation - can be raised for validation discrepancies. For example: changes in Manufacturing Instruction.
8. Material Complaint - raised to document any issues with regards to non-conforming, superseded or obsolete raw materials/components, packaging or imported finished goods.
9. System Routing Deviation - raised to track changes made to Bill of materials as a result of an Artwork change.

When to Report Deviation:
A Deviation should be raised when there is a deviation from methods or controls specified in manufacturing documents, material control documents, standard operating procedure for products and confirmed out of specification results and from the occurrence of an event and observation suggesting the existence of a real or potential quality related problems.

A deviation should be reported if a trend is noticed that requires further investigation.
All batch production deviations (planned or unintended) covering all manufacturing facilities, equipments, operations, distribution, procedures, systems and record keeping must be reported and investigated for corrective and preventative action.

Reporting deviation is required regardless of final batch disposition. If a batch is rejected a deviation reporting is still required.

Different Levels of Deviation Risks:
For the ease of assessing risk any deviation can be classified into one of the three levels 1, 2 & 3 based on the magnitude and seriousness of a deviation.

Level 1: Critical Deviation
Deviation from Company Standards and/or current regulatory expectations that provide immediate and significant risk to product quality, patient safety or data integrity or a combination/repetition of major deficiencies that indicate a critical failure of systems

Level 2: Serious Deviation
Deviation from Company Standards and/or current regulatory expectations that provide a potentially significant risk to product quality, patient safety or data integrity or could potentially result in significant observations from a regulatory agency or a combination/repetition of "other" deficiencies that indicate a failure of system(s).

Level 3: Standard Deviation
Observations of a less serious or isolated nature that are not deemed Critical or Major, but require correction or suggestions given on how to improve systems or procedures that may be compliant but would benefit from improvement (e.g. incorrect data entry).

How to Manage Reported Deviation:
The department Manager or delegate should initiate the deviation report by using a standard deviation form as soon as a deviation is found. Write a short description of the fact with a title in the table on the form and notify the Quality Assurance department within one business day to identify the investigation.

QA has to evaluate the deviation and assess the potential impact to the product quality, validation and regulatory requirement. All completed deviation investigations are to be approved by QA Manager or delegate. QA Manger has to justify wither the deviation is a Critical, Serious or Standard in nature. For a deviation of either critical or serious nature QA delegate has to arrange a Cross Functional Investigation.

For a standard type deviation a Cross functional Investigation (CFI) is not necessary. Immediate corrective actions have to be completed before the final disposition of a batch. Final batch disposition is the responsibility of Quality Assurance Department.

If a critical or serious deviation leads to a CFI, corrective and preventive actions should be determined and follow up tasks should be assigned to area representatives. Follow up tasks should be completed within 30 business days of the observation of deviation. If a deviation with CFI can not be completed within 30 business days, an interim report should be generated detailing the reason for the delay and the progress so far.

After successful completion of the Follow up tasks Deviation should be completed and attached with the Batch Report /Audit report/ Product complaint report /Safety investigation report as appropriate.

What To Check During The Deviation Assessment:

QA delegate has to conduct a primary Investigation on the deviation reported and evaluate the following information

1. Scope of the deviation - batch affected (both in-process and previously released)
2. Trends relating to (but limited to) similar products, materials, equipment and testing processes, product complaints, previous deviations, annual product reviews, and /or returned goods etc where appropriate.
3. A review of similar causes.
4. Potential quality impact.
5. Regulatory commitment impact.
6. Other batches potentially affected.
7. Market actions (i.e. recall etc)

A Standard Procedure For Quality Assurance Deviation Management
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Essential elements of a good quality management system are described in this article for pharmaceutical industry. Check more in Pharmaceutical Quality Procedures

Wednesday, February 6, 2013

7 Steps To Developing A Risk Management Plan

Risk is real for any company or organization. Don't kid yourself. Things happen when you least expect them to happen. Are YOU ready for the unimaginable, the unexpected, the unwanted? As an executive, have you put your head in the sand around risk? Do you pretend that all is well, and nothing will change? If so, it's time to face reality: data gets lost, buildings burn, people resign. When any of these occur, your organization is at risk for malfunction, inefficiency, chronic struggle, revenue loss, and even total failure. Is this the path you want to go down?

Beginning now, you can initiate the process of developing your organization's risk management plan. Take charge. Form a committee representing Board members and staff, and ask them to partner with you to create this critical document. Make sure everyone understands the importance of the work, and explain to them how they can benefit from contributing to the finished product. Risk managements plans are not optional; they are essential for every company, large or small. There are no valid exceptions.

Implement the following seven steps, and give yourself and others a huge slice of peace of mind:

7 Steps To Developing A Risk Management Plan

1.  Define what risk looks like for your organization.
What constitutes risk in your shop? Threats to normal operations? Threats or compromises to people's safety? Loss of physical and electronic property? Loss of revenue? Decreased public/community support? Unethical behaviors?   Create a comprehensive definition of risk that means something to YOU and YOUR organization.

2.  Identify specific risks.
Ask the committee to brainstorm as many different risks as they can possibly imagine. Record them on a white board or flip chart. Examples of various risks include: firing of the chief executive, dwindling interest in one of your major products, departmental silos, Board infighting, inability to fundraise, economic downturn, layoffs, building fire, computer crashes, philosophical differences between key employees, extended leaves for managers, interruption in receiving necessary supplies. All of these are potential risks, and there are many others. Continue brainstorming until the group believes they have come up with an exhaustive list.

 3.  Categorize each risk.
Determine category names for the identified risks. Examples may be: Chief Executive, Board of Directors, Physical Property, Technology, Data, Employees, Products or Services, Customers/Clients, Stakeholders,. Place each risk under one of the selected categories. Create as many category names as you need.

4.  Rank each risk according to severity or significance.
Choose headings such as "most severe", "moderately severe", "of minimal concern". You don't have to use these same words for your headings, but be sure that your phrases adequately differentiate between the degrees of seriousness. Perhaps you would like to color code each risk according to its significance heading: red for "most severe"; black for "moderately severe", and green for "of minimal concern". Set it up the way it best works for you and your organization.

5.  Develop strategies for reducing or eliminating each risk.
Begin with the risks under your "most severe" heading. It's critical that you don't delay in thinking through possible solutions for those major issues. Ideally, determine multiple strategies for each risk. Be sure to consider who within the organization is going to be responsible for implementing the various strategies, and the resources needed to implement them. Omitting this information from the plan only causes big problems later.   

6.  Write your plan.
Using all of the above input, shape a readable document. Practicality is paramount here. The plan is worthless if nobody can follow it, interpret it, or actually rely on it as a guide during crisis. After it is compiled, seek feedback from the committee as well as other employees and Board members. Incorporate changes where indicated. Check for evidence of common sense throughout the document. Hold yourself accountable to a high standard around common sense. A pie-in-the-sky risk management plan doesn't serve anyone.

7.  Test some of those strategies in your plan for viability.
Do they work? Can they work? Why or why not? Where are the pitfalls? What steps are missing? Would you benefit from having certain outside experts review your strategies? If so, which types of experts? 

Revisions to the plan may occur annually, as situations arise and your organization lives one or two of the strategies firsthand. Hindsight is often wiser. Don't be afraid to toss some plan content when you know for a fact that this is what you must do. Remember: the plan needs to be current. On a day you least expect it, someone has to grab that document, refer to a particular section in it, and act upon it--fast.

7 Steps To Developing A Risk Management Plan
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Sylvia Hepler, Owner and President of Launching Lives, is an executive coach/advisor based in South Central PA. Her ideal clients are corporate executives, nonprofit executive directors, and business owners who demonstrate commitment to getting unstuck and creating a NEW story for their lives. Ms. Hepler's background includes: teaching, public speaking, retail sales, freelance writing, and executive leadership of a 14 county nonprofit organization. She has a working knowledge of staff supervision, Board development, Quality Management, SWOTT Analysis, the hiring and firing of employees, mission/vision development, networking, and organizational collaboration. Her no nonsense approach coupled with heart yields swift results with most clients.
CONTACT:
Sylvia@launchinglives.biz
717-761-5457

Sunday, February 3, 2013

Risk Factors in Implementing Total Quality Management in Your Organization

This TQM article is about Implementing Total Quality Management (TQM) in an organization. It is quite known to the business world that this is not an easy task. However, there is a systematic approach to assess its likelihood of success in implementing TQM provides an early sign for actions. Below are a set of questionnaires to assess 5 critical success factors for a Implementing Total Quality Management in an organization. It is a simple and direct questions asked to draw the readiness of an organization in its sate of preparedness. The questions should be answer in a skill of 0 to 10, being 0 is the lowest score and 10 is the highest score. when allocating score, the instantaneous answer in mind should be taken instead of think through too thoroughly. There are 2-3 questions to each of the Critical Success Factors.

Strategic Focus

To what extent are team improvement objective focused on strategic organization goals?To what extent are team success related to the organization financial success?

Risk Factors in Implementing Total Quality Management in Your Organization

Management Commitment

To what extent do senior managers review the progress of improvement teams?How often senior management involve in the team activities?How often are team improvement recommendations approved by senior management

Links to the Line Organization

How well are team improvement recommendations executed by the rest of the organization (other department with similar processesTo what extent improvement recommendations are derived from a systematic tools?To what extent are team improvement recommendations piloted before a solution is launched?

Organizational Versus Functional Focus

To what extent are employee in your organization rewarded for meeting organization goals? How well do employee work across functions and departments in your organization?To what extent are team emphasize on organization improvement project as opposed to functional projects?

Methods and Support

To what extent do your teams get training and support from trained facilitators on a regular basis?To what extent do your teams follow a consistent Improvement Methodology?To what extent do your sponsor understand the Improvement Methodology?

In summary: Upon completion of all the questions, you can draw the score into a radar chart with the high score at the outer sphere of the radar chart. The shape of the radar chart would provide a clear indication which is the area of focus for improvement. These questionnaires should be taken as an indicators for success in Implementing Total Quality Management.

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Disclaimer: This article is written by the author based on his practical application experience. All definitions and interpretation of terminology are his point of view and has it has no intention to conflict with experts in similar topic. The author holds no responsibility for the use of this article in any way.

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Risk Factors in Implementing Total Quality Management in Your Organization
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Dr. LM Foong, PhD
He provides consulting services specializing in TQM Implementations in manufacturing and service sector. He provides facilitation workshops and hands-on application in Cost Reduction and Productivity Improvement projects. He publishes TQM articles, ebooks, case studies, trainer manual and presentation slides. Please Visit my Web Site http://www.tqmcasestudies.com for other TQM related matters. He can be contacted at http://www.tqmcasestudies.com/ContactUs.html