Simple Steps to Ensure Quality Control

Sat, 26 May 2012 11:12:00 GMT

Many executives realize the responsibility for FDA compliance is one of the many frustrating and never ending aspects of the job. A well-prepared and thoroughly executed Quality Control and Compliance system is not only one of the more stressful parts of the job – it’s a necessity to ensure compliance at every step of the organization’s operations.

Despite the fact that Quality Control is so necessary, a lack of quality control measures and implementation procedures continues to hurt businesses. It ends up on the back burner for many of those tasked with the responsibility for maintaining compliance in their organizations.

You may be thinking that your compliance is acceptable and intact, and that merely the presence of a Quality Control, Compliance or Assurance department and its operations are sufficient enough to ensure compliance. If you haven’t been concerned about whether or not your Quality Control Systems are up to par, and if your company could withstand an FDA Audit, or receipt of a 483 warning letter, consider since 2009, 483 Warning Letters are up 23%.

Taking a few simple steps to ensure appropriate Quality Control measures and operations are in place could save you a big headache later – and it could also save your business.

Many executives and other upper level management are aware that they need to intensify Quality Control directives within their businesses, but the “status quo” has changed. Many organizations are not aware that it is not enough to ensure acceptable Quality Control in today's zero tolerance FDA environment. To ensure that your operation is in compliance, you will need to do more.

Start by organizing an internal audit. If there’s any doubt that you could survive an FDA Audit, or that you’re in compliance with FDA Regulations, it’s time to develop a corrective protocol. This protocol should become top priority, not only to you and upper level management, but to ALL employees – particularly those at the Quality Control level.

Quality Control staff should be working with you to implement a compliance structure that will ensure all employees comply. Your audits should also be implemented regularly, to ensure that any corrective measures are maintained between audits.

Proper Quality Control to ensure FDA compliance isn’t just an ordinary hassle of the job – avoiding proper compliance measures, whether due to cost or convenience, has been a direct cause of businesses shutting down before, and will again.

Understand what challenges your business is facing, and if necessary, work with a cost-effective strategist or consultant to help develop Quality Control measures that meet the criteria set forth in FDA regulations.

You’re thinking big - More growth and More innovation

Thu, 24 May 2012 12:24:00 GMT

Your plans include a high-performing, highly responsive technology infrastructure to support it all. Question is who’s supporting your technology infrastructure? Ongoing, comprehensive and proactive support of your hardware, software and IT environment is crucial.

The bottom line: If your IT assets aren’t working, neither are you. Granted, you expect a lot from your IT environment. Not only must your infrastructure help ensure high availability and quality of existing services, but it needs to provide real-time, dynamic access to services.

A dynamic infrastructure—the foundation for organizations to become more cost-effective, responsive and resilient—can dramatically optimize IT services. But it can also introduce new complexities when it comes to keeping IT up and running.

Reducing the complexity of technical support isn’t easy when the average technology infrastructure is increasingly made up of multiple systems, platforms and vendors. It takes a trusted support resource—one who has the experience and knowledge to enable highly effective monitoring and expert utilization of your assets.

An Accenture report titled Technology Vision 2011 outlines the following trends:

Things will be distributed

The obvious and immediate realization is that data today is spread far and wide. Data is also dispersed across many more locations, and under the control of far more owners. At the same time, services will be distributed more widely. Analytics will follow data and services, and will become distributed too. All of which accentuates the importance of factors such as master data management, secure communications, and federated identity.

2. Things will be decoupled

Technology today enables decoupling of entities and layers once deemed inseparable. Data representation is being decoupled from data access. Software layers can be addressed separately. Application interfaces no longer need to be tied to physical interfaces. Decoupling on such a scale promises unprecedented agility and flexibility. But it also calls for a very different mindset—and skills set—and for wise governance disciplines.

3. Things will be analyzed

Since everything from keystrokes to consumer behavior can now be tracked and studied, analytics will become the super-tool with which to drive more agile and effective decision-making. Business processes will have to keep pace if those super-tools are to be effective. There are a host of positive implications, in categories as diverse as customer intelligence and threat detection. But there is no shortage of negative implications—among them the risks to data privacy and the over-optimization of business processes.

How will competition impact how your business use and organize IT in your enterprise. Yet while global competition is intense, how today’s competitive trends may play out and shape the coming years is far from clear. To prepare their IT future, you must consider the ways the future could turn out and ask ten key questions to see what these different “futures” will require from their IT leadership and organizations.

Like us on our Facebook page to get Accenture's ten key questions every executive must ask themselves about how they should use and organize information technology to grow their business and increase innovation.

The Reason For FDA Warning Letters

Mon, 21 May 2012 10:49:00 GMT

Validation deficiencies are still the number one reason for the issuance of FDA warning letters. Regulatory agencies are calling for more “state-of-the-art” systems to replace older manual systems.

Validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.

Validation systems are still almost entirely manual or consist of a number of disparate, uncoordinated systems. Inefficiencies caused by human error cost manufacturers millions of dollars annually, increase product time-to market, and introduce quality problems that canresult in regulatory actions including stringent penalties.

Validation has been an essential part of regulated industries for over 20 years, yet as the field has evolved, little has changed in the business, or manual, approach to validation. Over time the traditional validation activities have become centered on documentation, which has increased tremendously and led to additional quality issues.

For the most part, validation still requires a high degree of manual effort for tracking and reporting, and the execution of most validation protocols takes place on paper. Although regulated life sciences companies involved in manufacturing have successfully been able to leverage advances in computer technology to manage their many aspects of their Quality process, validation has remained a largely paper based process.

Until recently, the FDA has remained silent on the issue of adapting electronic systems to manage the validation process. However, with the emergence of the FDA's latest draft guidance for process validation, it is implied that electronic systems are required in order to effectively meet the new requirements. The FDA’s new guidance for Process Validation is a big step forward in process-centric product development that will result in building quality into the process.

The FDA considers any use of computers or automated data processing systems as part of the production or quality system to require control. Manufacturers must:

Identify the intended use of the computer or automated data processing system;

Validate the computer, software, or automated data processing system for that use;

Re-validate those systems appropriately for each software change or change to the system; and

Fully document, review, and approve all system validation activities within the company.

FDA expects that validation of computer systems fully ensures that the system performs as expected and anticipated. If knowledgeable system validation resources are not available from within the manufacturer, the agency expects the manufacturer to obtain an outside, independent resource to either provide appropriate training or perform the system validation.

Effective validation contributes significantly to assuring product quality. The basic principle of quality assurance is that a regulated product, a drug, medical device, cosmetic or food should be produced for its intended use.

CAPA - The Cornerstone of a Quality Program

Mon, 14 May 2012 10:18:00 GMT

Today, CEOs face the daunting challenge of competing in global markets and are employing highly effective strategies to out pace their competitors to create greater profitability.

More than 50% of the Warning letters and Form 483s issued by the FDA are for CAPA violations. Clearly having an effective CAPA program in place is the cornerstone for any quality system in a FDA regulated business and a vital part of maintaining a viable and profitable business.

A concept found with Good Manufacturing Practice (GMP), Corrective and Preventive Actions is comprised of two important sub-systems. Corrective Action addresses a nonconformance issue that has happened in the past in order to prevent its recurrence. Preventive Action however, focuses on preventing a discrepancy from occurring in the future.

A common misconception is Preventive Action is taken to prevent the recurrence of a similar problem in the future. For example, "when a company receives a customer complaint or defective product, the action it takes is categorized under Preventive Action. However, it is in reality Corrective Action as it deals with a problem that has already occurred.

Preventive Action, in contrast, deals with the proactive steps taken by a company to ensure that a problem does not occur in the first place" Mr. Nugent goes on to say. Both systems however, require the comprehensive reporting of nonconformance in carefully maintained logs: a Corrective Action log and Preventive Action Log. A Corrective Action Request or a Preventive Action Request will be made to record the steps taken to address the identified discrepancy.

A company will typically have many Corrective Action Requests and only a few Preventive Action Requests. For audit purposes, however, a few Preventive Action Requests will demonstrate that Preventive Action is a functioning part of the quality management system. Rigorous regulatory requirements mean CAPA systems must have an extremely high level of accuracy and consistency that ensures that all important details are documented and issues clearly identified. For corporate entities, having software solutions and professional services to help them in this important process will often be crucial.

Senior executives are employing new solutions and strategies to streamline internal processes that drive efficiencies, increase productivity and create differentiation. An effective CAPA system will lead to improved business processes – a key part of any quality management system is a vital part of maintaining a viable and profitable business, particularly in the regulated industries.

Improving the Quality of Your Operations and Products

Wed, 09 May 2012 12:38:00 GMT

If you’re thinking of CFR 21 Part 11 compliance in terms of what the FDA may or may not require, you’re missing a huge opportunity to make your business more efficient, nimble and ultimately profitable by improving the quality of your operation and its products.

That’s the consensus of dozens of your colleagues at FDA-regulated firms and FDA agents. Savvy industry players have used Part 11 to get a better handle on their operations to speed delivery of product to market and improve clinical trial efficiency by days and even weeks.

Any electronic record system that can’t comply today should not be in service. With the exception of open and electronic signature systems, the controls required today by the FDA for Part 11 aren’t significantly different from the agency’s expectations for validated computer systems dating back to the late 1980s.

The cost-benefits of Part 11 compliance are difficult to break out as a separate line item on the budget, but the fact that they save companies time and money is self-evident. Validation and data integrity controls are good business practices and over the long-term use of the system, there is a significant cost savings to properly planning and implementing a system.

Much of that cost-benefit is realized by improving the quality standards at the company’s operation.

Part 11’s Return on Investment

Part 11’s compliance cost-benefit clearly affects two areas: overall use and support of the computer system and the assurance that the company’s data is complete and accurate. The effort to define what the system is supposed to do, making sure it does it, and keeping it under control (i.e., validation, specification, verification and control), ensures a system that meets the needs of the business, works correctly and consistently, and is not constantly changing.

This means that you will have a good return on the investment as the system will help with the business operation, and the cost of support is lower because the system will have fewer problems.”

Regardless of any FDA requirements, it’s important that any efficient FDA-regulated operation make sure that its computer system works according to its intended use at the time of the installation and during on-going use. Computer system validation (CSV) boil down to keeping a system under control and providing a company with the evidence that it performs as intended on a day-by-day basis. Part 11 compliance is a foundation to improving overall system quality.

The FDA’s Mistake

As many people who work for the agency would freely admit, the FDA made a mistake when it first unveiled Part 11 in 1997, and only compounded the problem when it revised Part 11 in subsequent guidance updates.

Unintentionally, the agency made the requirements so vague and potentially onerous that many firms began to shy away from using electronic records and hung on to good old paper. That was never the agency’s intention; instead the FDA wants to encourage the use of e-records with data integrity. But when the agency clarified, and in many ways eased, its Part 11 requirements in 2003, many companies in the industry relaxed and decided they could go to the other extreme, basically ignoring Part 11 requirements.

Many otherwise savvy industry players have used Part 11 to get a better handle on their operations to speed delivery of product to market, improve clinical trial efficiency by days and even weeks.

The Quality System Habit

Mon, 07 May 2012 11:46:00 GMT

Companies whose products are regulated by the FDA, especially pharmaceutical and medical device companies, stand to increase their workable ROI by millions of dollars with quality system technology that accelerates innovation and streamlines compliance.

Many compliance and quality driven processes are now matters of course within regulated life science environments. Executives whose products must meet regulatory and ISO guidelines know how to produce and they know how to control their output. Companies simply know what works and they stick to it. FDA regulated industries are subject to the fact that habits when left unchanged have a nasty way of turning the tables on good fortune.

The good news is that new habits once implemented often maintain the balance that everyone and every business (including life science companies) want to maintain.

The Quality System Habit

For some companies one of the most difficult habits to dispense with is the manner in which quality systems are controlled. Quality systems (i.e., document control, deviations control, non-conformance, equipment calibration, equipment maintenance orders, audit, CAPA, change control, training and the overall functions and philosophy that control product outputs) are often controlled manually or with a hybrid system.

Quality system documentation, for example, though it is the lifeblood of a quality system and is required by most regulatory organizations (FDA, ISO, CLIA, etc.), is often routed, viewed, approved and archived using paper-based or hybrid systems.

These manual or hybrid processes greatly slow the pace of a product to market and literally cost many life science companies hundreds of thousands or even millions of dollars for every day a product is delayed.

In addition, employees who undertake these manual processes are also being paid for tedious tasks when their time could be put to better use.

Those companies that implement the right technology at the right time are those companies that effectively streamline and catalyze their processes and their ROI. Life science companies need to make a habit of looking for new technology habits, especially for those technologies that are subject to continual development. For companies whose products are regulated by the FDA, the time is especially ripe for new quality system technological solutions.

In addition, a quality system that provides analytical and reporting features makes deviations and non-conformance data far easier to analyze, and with streamlined connections deviations and non-conformance data can be configured to trigger results from CAPA, change control or training solutions.

Furthermore, quality system solutions that make communication simpler, such as web-based solutions that allow for collaboration, are especially valuable as are solutions that provide audit trails for documentation and all quality system related processes.

The call is out for pharmaceutical, medical device and other companies that need to meet FDA regulations and ISO requirements to consider the new habits that quality system technology can present.

Too Much Data with Too Little Insight

Thu, 03 May 2012 12:32:00 GMT

Think about your business environment—that broad network of relationships and interactions that make up your business. It encompasses the people and systems inside and outside your organization.

Above all, it’s constantly changing. Suppliers come and go; regulations change and new relationships emerge. Underlying these business connections are a wide array of different applications. The ability to make faster, more effective connections between these disparate applications across an ever broader, more dynamic business network is fundamental to the success of accelerating innovation and streamlining compliance.

Take the next step

Concepts such as optimizing business processes, improving decisions, enabling cloud capabilities, connecting the business network, and providing an exceptional application environment are all relevant to any enterprise that uses information technology.

The life science and healthcare industry are experiencing fundamental transformation as it moves from a volume-based business to a value-based business. With increasing demands from consumers for enhanced healthcare quality and increased value, healthcare providers and payers are under pressure to deliver better outcomes. Primary care physician and nursing shortages require overworked professionals to be even more productive and efficient.

The cost dynamics of healthcare are changing, driven by people living longer, the pervasiveness of chronic illnesses and infectious diseases, and defensive medicine practices. For life science companies new market entrants and new approaches to drug innovation are increasing complexity and competition. As tumultuous as the current environment is, it is expected to become even more complex over the next several years.

Among executives interviewed for an IBM Global CEO study, 90 percent expect a high or very high level of complexity over the next five years, but more than 40 percent are unprepared to deal with it. This immense complexity confronting the healthcare and life science industry will require smarter, more informed decisions to enable the improved outcomes and better value required by market dynamics, increasing governmental regulation, and today’s more demanding consumers.

The increasing regulatory presence of government places additional focus on accountability, governance and oversight on the industry. Market dynamics and competitive pressures require enhanced understanding of underlying trends and a path to differentiation.

The multitude of volatile changes sweeping the industry is exacerbated by the proliferation of clinical information systems, electronic health records and connected medical devices that have created an unprecedented information explosion. In the 2010 IBM Global CEO study, 93 percent of healthcare providers identified the information explosion as the biggest factor anticipated to influence their organizations to a large extent over the next five years.

The abundance of data that bombards healthcare professionals both facilitates and complicates the ability of healthcare payers and providers to achieve and influence desirable outcomes. However, this wealth of information is a double-edged sword. The glut of information makes it progressively more difficult to distinguish between essential data and clutter.

In fact, the data paradox – the management dilemma presented by too much data and too little insight – is an increasingly daunting obstacle to creating effective analytics strategies.

Managing the Transition between Compliance and IT

Tue, 01 May 2012 12:04:00 GMT

In recent years, the life science industry and healthcare organizations has given greater priority and attention to quality assurance and regulatory compliance than ever before. With the FDA’s heightened focus on safety, regulatory agencies are increasing their presence in the manufacturing arena to ensure Current Good Manufacturing Practices cGMP are top of mind.

Companies are placing greater responsibility for meeting cGMP requirements onto their outsourcing partners.

Careful choice of a service provider is the essential first step to ensure high quality services. Today sponsors review a service providers quality programs as early as the due diligence audit in the selection process. They seek partners who adhere to cGMP regulations and other regulatory requirements and have strong information technology background.

Your IT department is staffed to handle general day to day needs and struggle with the upheaval caused by transition. Outsourcing the management of the transition to an IT consulting firm is the best way to handle the disruption while minimizing cost and risk.

The results from Accenture’s third global IT performance research initiative underscore the challenges that CIOs are facing as they cope with the continued effects of the economic downturn while also striving to increase the strategic impact of IT. Forging an optimal path forward depends on making investments in new applications and technologies.

Yet in today’s economic environment, the ability to make those investments depends on a smarter, more targeted approach to cost management and control. Simultaneously managing cost cutting and reinvesting is one of the toughest challenges CIOs face.

Competitive advantage occurs when an organization acquires or develops an attribute or combination of attributes that allows it to outperform its competitors. These attributes can include access to technical resources or access to highly trained and skilled personnel.

Information technology has become such a prominent part of the global business environment that it can also contribute to competitive advantage by outperforming competitors. Companies are adopting a sustainable business model to reduce information technology infrastructure costs that support business related priorities.

The day has passed when companies could afford to build excess technical infrastructure, suffer the time and cost of assembling and, in many cases, disassembling teams, and incur delays in project progress that undermine optimal returns.

Integrating Global Quality and Compliance

Wed, 25 Apr 2012 14:17:00 GMT

With the growing global economy, the risks of imported products are increasingly shared by countries around the world. Now more than ever, effective public health protection requires a range of stakeholders, including government agencies, industries, academia, non-governmental organizations, and scientific communities, to work together in partnership toward a single goal: protecting public health worldwide.

The FDA has written a new report titled Global Engagement in response to these challenges, FDA has embraced a wide variety of strategies that increase its engagement in the global public health community, integrating the Agency’s knowledge of how products are developed, manufactured, and delivered worldwide, and its ability to ensure that the imported products available to U.S. consumers are safe and effective.

The ability of government authorities to ensure the availability of safe, high quality food, medical, and other FDA-regulated products by effectively performing critical regulatory functions—includes product review, registration, licensing, inspection, laboratory testing, and post-market surveillance.

With substantial U.S. consumption of imported food and medical products, the ability of other countries to ensure the safety and quality of products they export has direct relevance to U.S. public health. A vital element of FDA’s global engagement portfolio, strengthening regulatory capacity promotes the safety of imported products and improves the control of diseases before they reach U.S. borders.

In addition, stronger regulatory capacity abroad significantly improves the health and quality of life for individuals and communities in the developing world, and helps reinforce and secure public and private investments in the development of new drugs and vaccines, as well as agriculture and food production.

Capacity building activities can take place at multiple levels: a country’s regulatory environment, its organizations and institutions, and/or with individuals in the relevant scientific and regulatory communities.

Advancing Regulatory Science. The rapid advances in science and technology that have contributed to the pace of globalization offer tremendous promise for promoting and protecting the safety, quality, and security of FDA-regulated products. FDA is actively engaging with global partners to harness scientific developments and pool products, resources, and brainpower to support science-based regulatory decision-making and pursue the best possible public health solutions.

In addition, as described in FDA’s 2011 special report, Pathway to Global Product Safety and Quality, the Agency is working to transform itself over the next ten years from a domestic agency operating in a globalized economy to a truly global agency fully prepared for the regulatory pressures of globalization.

Toward that end, the Agency will be collaborating closely with its foreign counterparts to assemble global coalitions of regulators dedicated to building and strengthening a worldwide product safety net, including a global data information system they can use to proactively share real-time information and resources across markets. To achieve a true and lasting paradigm shift, FDA will be engaging stakeholders in a process that will unfold over the next several years.

Reducing Risk In Quality Systems

Mon, 23 Apr 2012 14:35:00 GMT

Quality Management Systems are structured around interlinked processes that provide the necessary implementation controls to ensure customer and regulatory requirements are met and continual process improvement.

These processes define activities that are directly necessary to create the item or service and those that provide the supporting infrastructure to enable the direct processes to operate under the required controls and continual improvement.

Companies are always looking for ways to improve product quality, customer satisfaction and profitability while balancing increased costs and regulatory pressures.

Too often they address their quality and regulatory requirements by implementing modular, point solutions that meet specific needs. This approach has led to the proliferation of a wide variety of non-integrated systems that may help individual departments or divisions manage their responsibilities but have created data islands.

This approach creates risk for your company!

Many companies have been using a “quasi-risk based” approach for years. Requirement documents have been used to help identify key process components, often times weighting them to assign to them a priority based on their relative importance.

Managers are responsible for ensuring that all activities affecting the quality of items and services are accomplished in accordance with controlled documents such as quality system manuals, procedures, work instructions and controlled data such as customer order requirements and documents of external origin.

Each manager with lead responsibility for a document or document series is responsible for establishing controls that define responsibility, authority, issue use and revision and control for the document or document series.

Document control procedures identify the following:

Format and content guidelines
Requirements to ensure that documents are complete, correct, current and in compliance with applicable technical, quality and administrative requirements
Individuals within the company are responsible for review and approval of documents and revisions
Requirements for the release and issue of approved documents to ensure that responsible personnel are promptly provided with current document revisions at the location where the document is used
Requirements for document effective and or issue dates
Requirements for identifying what has been revised
Requirements for maintaining document master lists and controlled distribution lists
Provisions for reissuing drawings after a practical number of changes have been identified or approved for inclusion

All levels of management are responsible for assigning responsibility to ensure that documents and data are controlled in accordance with established procedures and resolving issues pertaining to policy and procedure content, application and use.

Transformational Shifts on the Horizon for FDA

Fri, 20 Apr 2012 10:54:00 GMT

In a Special Report by the FDA titled, Pathway to Global Product Safety and Quality, the FDA has been a recognized world leader in product safety standards. As the agency looks to the future, it can no longer rely on the historical tools, activities, and strategies to regulate products.

The reality facing FDA is that its mission will become ever more difficult to fulfill given the breadth and complexity of industries that it regulates during a time of constrained federal resources.

In order to cope with the magnitude of the fundamental shifts on the horizon, the agency is committed to substantially and fundamentally revising its approach to global product safety and quality. Over the next decade, FDA will transform itself from a domestic agency operating in a globalized world to a truly global agency fully prepared for a regulatory environment in which product safety and quality know no borders.

To achieve this transformation, FDA is developing an international operating model that relies on enhanced intelligence, information sharing, data-driven risk analytics, and the smart allocation of resources through partnerships. The new approach rests on four core building blocks:

1) FDA, in close partnership with its foreign counterparts, will assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world.

2) With these coalitions, FDA intends to develop a global data information system and network in which regulators worldwide can regularly and proactively share real-time information and resources across markets.

3) FDA will continue to expand its capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized IT capabilities.

4) FDA will effectively allocate agency resources based on risk, leveraging the combined efforts of government, industry, and public- and private-sector third parties.

Because the changes shaping the world of the future will be so large and so fundamental, FDA must substantially evolve its product safety and quality model in order to keep ahead of the coming risks. Import growth will accelerate at the same time that highly-sensitive production processes are moving to new geographies. Increased access to the global marketplace will increase the specter of harm to consumers from economic or other intentional adulteration, fraud, and counterfeiting.

FDA has already begun working diligently to build relationships with global and domestic partners, pushing for strong global safety standards. However, the magnitude of the challenge will require faster progress towards closer cooperation than has happened in the past.

Computerized System Validation Principles

Tue, 17 Apr 2012 09:37:00 GMT

Regulated pharmaceutical, biotech and medical device companies are challenged to develop manufacturing capabilities quickly and cost-effectively while at the same time safeguarding product quality and patient safety.

Until recently, the FDA has remained silent on the issue of adapting electronic systems to manage the validation process.

However, with the emergence of the FDA's latest draft guidance for process validation, it is implied that electronic systems are required in order to effectively meet the new requirements. The FDA’s new guidance for Process Validation is a big step forward in process-centric product development that will result in building quality into the process.

The FDA considers any use of computers or automated data processing systems as part of the production or quality system to require control.

Manufacturers must:
 Identify the intended use of the computer or automated data processing system;
 Validate the computer, software, or automated data processing system for that use;
 Re-validate those systems appropriately for each software change or change to the system;
 Fully document, review, and approve all system validation activities within the company.

A successful validation program depends upon information and knowledge from product and process development. This knowledge and understanding is the basis for establishing an approach to control of the manufacturing process that result in products with the desired quality attributes.

Each manufacturer should judge whether it has gained sufficient understanding to provide a high degree of assurance in its manufacturing process to justify commercial distribution of the product. Focusing exclusively on qualification efforts without also understanding the manufacturing process and associated variations may not lead to adequate assurance of quality.

Developing a Quality and Compliance Culture

Wed, 11 Apr 2012 13:43:00 GMT

In a recent article written by Erica Brooks and Yasmeen Muhammand, of Compliance Implementation Services, for PharmaManufacturing.com, the authors write about “ a company’s quality system is only as good as the people managing those systems".

The authors point out “If a company doesn’t have a culture of compliance coming from top management down, the systems are likely to fail which could lead to misbranded or adulterated products that could be injurious to the consumer health”.

“In some cases, the top managers are fired from the companies or debarred from the Industry”.

The task of actually implementing a quality management system at a life science company can be daunting because of several factors:

Lack of constancy of purpose to plan product and services that will have a market and keep the company in business and provide jobs.
Emphasis on short-term profits
Management by fear

Cost pressures stemming from the global economic downturn and management changes every three to four years means continuous improvement efforts will be broken and disjointed as new leaders come on board.

There’s an opportunity for top management to emphasize the importance of Quality and Compliance when visibility into key quality metrics is monitored. Companies that do well on quality have everyone through the value chain accept ownership for Quality.

Additionally, the quality organization maintains a high-level, strategic focus on Quality, which alerts the company to changes in the external environment that requires a shift in systems or actions and develops and maintains a system of checks and balances.

Visit the ASQ Website to Watch THE COST OF POOR QUALITY

Business leaders, along with Quality Staff, can no longer afford to take a traditonal approach to this heightened regulatory environment. In today competitive areana there are a slew of risks which are collectively putting unprecented strain on companies.

A Quality System is the organizational structures, processes, procedures and resources used to manufacture products in accordance with applicable regulations. This entails quality planning, quality control, quality assurance and quality improvement for achieving consistne product quality.

Whether you’re a seasoned quality management professional looking for a fresh start or a young quality manager just starting your first position, you face enormous challenges in managing your quality and compliance initiatives. It’s not enough to be aware of the basics of quality because market trends point to even greater scrutiny on these efforts as pressure mounts from both consumers and the FDA to deliver safer products and services.

Implementation of FDA’s Design Control Requirements

Mon, 09 Apr 2012 10:09:00 GMT

Implementation of FDA’s Design Control requirements (21 CFR 820.30) changed an entire medical devices and diagnostic industries. The Quality system requirements define the approach to medical device validation, product design, manufacturing process, and test method validation studies.

Validation studies must demonstrate that product design, process, test methods, requirements and specifications determined during development can be met in the environment the product will be used in.

Medical device validation is a complex process that must be completed and documented before releasing the products into market to meet the strict regulatory requirements including FDA. Success in the Medical Device industry requires adherence to applicable FDA regulations - ISO 13485, ISO 14791, 21 CFR 820 and 21 CFR Part 11.

The FDA believes through careful design and software validation of the process and process controls, a medical device manufacturer can establish a higher degree of confidence. Successfully validating a process will reduce the dependence upon intensive in-process and finished product testing.

The current validation process is predominantly manual and paper based. The paper-based manual validation processes, stifles innovation, causes compliance risks and compromises a medical device firm’s ability to bring products to the market on time. Inefficiencies in the validation process cost regulated manufacturers millions of dollars annually, mainly attributed to the use of paper, or paper/hybrid.

Replacing an inefficient paper-based validation process with a paperless, electronic system, manages the entire validation process end to end, dynamically tracking validation status in real time, streamlining the process, improving communication between all stakeholders and ensuring and enforcing compliance and consistency throughout the whole corporate validation process.

FDA regulated manufacturers need help to implement and enforce validation standards and procedures that are typically buried in validation master plans, SOPs and policy documents. Life Science companies can replace tedious paper based manual system with an electronic, automated validation lifecycle management system that supports the risk based approach and makes the Computer Software Validation process 100% electronic.

To view a short video on validation, click here

Using an electronic, automated validation lifecycle management system technology can help with Planning, Risk Assessment (FMEA), Requirements Management, dynamic Traceability Matrix creation, Document Authoring, paperless Electronic Execution, Periodic Review scheduling and Content Management

Pharmaceuticals and Biotechnology industries etc. can efficiently handle their unique asset management processes with real time validation status using new technology.

An electronic, automated validation lifecycle management system is designed to manage the complete validation lifecycle for computerized systems. Equipment Validation and qualification is a time consuming process that has the potential to delay the release of products to the market.

The FDA describes in the latest draft process validation guidance that, “In all stages of the product lifecycle, good project management and good archiving that capture scientific knowledge will make the process validation program more effective and efficient. These practices should ensure uniform collection and assessment of information about the process, reduce the chance for redundant information gathering and analysis, and enhance the accessibility of such information later in the product lifecycle.”

It is almost impossible to achieve this requirement without using a software platform in order to access information quickly throughout the product lifecycle.

Integrating The Principles of Lean in Your QMS

Fri, 06 Apr 2012 11:01:00 GMT

For organizations to function effectively they have to identify and manage numerous interlinked, cross-functional processes, always ensuring customer satisfaction is the target that is achieved.

The adoption of a QMS needs to be a strategic decision of an organization, and is influenced by varying needs, objectives, the products/services provided, the processes employed and the size and structure of the organization. A QMS must ensure that the products/services conform to customer needs and expectations, and the objectives of the organization.

Issues to be considered when setting up a QMS include its:

• Design

• Build

• Control

• Deployment

• Measurement

• Review

• Improvement

Taking each of these in turn:

Design and build includes the structure of the quality management system, the process and its implementation. Its design must be led by senior managers to suit the needs of the organization, and this is ideally done using a framework to lead the thinking. Design of the QMS should come from determining the organization’s core processes and well-defined goals and strategies, and be linked to the needs of one or more stakeholders.

The process for designing and building the QMS must also be clear, with the quality function playing a key role, but involvement and buy-in to the system must also come from all other functions.

Deployment and implementation is best achieved using process packages, where each core process is broken down into sub-processes, and described by a combination of documentation, education, training, tools, systems and metrics. Electronic deployment via Intranets is increasingly being used.

Measurement is carried out to determine the effectiveness and efficiency of each process towards attaining its objectives. It should include the contribution of the QMS to the organization’s goals. A form of scorecard deployed through the organization down to individual objective level can be employed, and the setting of targets at all levels is vital.

To watch a video on Integrating The Principles of Lean in Your Quality Management System, click here.

Review of the effectiveness, efficiency and capability of a QMS is vital, and the outcome of these reviews should be communicated to all employees. Reviewing and monitoring should be conducted whether or not improvement activities have achieved their expected outcomes.

Improvement should follow as a result of the review process, with the aim of seeking internal best practice. It is part of the overall improvement activities and an integral part of managing change within the Organization.

ISO 9000 contains eight quality management principles, upon which to base an efficient, effective and adaptable QMS.

FDA Warning Letters and 483s

Wed, 04 Apr 2012 12:27:00 GMT

No medical device, biotech or pharmaceutical manufacturer wants to receive a Form 483 and/or Warning Letter from the US Food and Drug Administration (FDA) and failing to ensure a proper response to satisfy the FDA can be fatal to your business.

Download 483 Warning Letter Report

When an inspector(s) arrives, they provide the company with a “Notice of Inspection”, which contains the purpose of the inspection. The FDA conducts established inspections for either enforcement or information gathering (surveillance) purposes. FDA inspectors can notify the company of their upcoming inspection or they can arrive unannounced.

At the end of the inspection, which can last a few hours to several weeks, specific and significant inspection observations are identified on Form FDA 483, with the most significant observations listed first. The company is obliged to respond to the observations and FDA warning letters. An establishment report of inspection will be issued, which provides a complete summary of the overall inspection process.

Following an Inspection Assess Each Observation

Focus on specifics
Focus on system-wide implications
Focus on global implications
Consider affected products
Consider root-cause analysis
Focus on the regulatory requirement(s) associated with the observation

A serious challenge is to deliver safe, profitable products on-time, every time. Strict FDA oversight intensifies the pressure as companies struggle to get their products to market while fully meeting regulatory requirements.

Failures not only result in 483s, consent decrees and product delays, but often erode a company’s public image affecting market share and profits. Finding ways to increase revenues, while maintaining compliance and high levels of product safety is essential to maintaining a competitive edge.

FDA inspection process has been that of a federal agency’s “official”, careful, and critical examination of a regulated manufacturer. An establishment inspection report (EIR) is issued, which provides a detailed summary of the overall inspection. All documentation of observed violations and all documents routinely collected (and specified in the manual) are attached to the EIR. FDA inspection process can be very comprehensive in nature. Firms therefore need to be well prepared before the arrival of the FDA investigators.

The field investigator will in all likelihood audit development data during FDA inspection process for authenticity as well as for accuracy. Additionally, he/she will determine if the facilities, mishandling of products, personnel, equipment, and laboratory methods adequately support the manufacturing process in the NDA. These items are part of the FDA inspection process.

Harnessing Big Data - Too Much Information but Little Insight

Mon, 02 Apr 2012 12:26:00 GMT

Today business systems are talking to each other and communicating about the data going through Quality systems. Having more corporate visibility into Quality has enabled other areas of the organization, Design, Production and Corporate to mitigate risk and accelerate innovation.

Analytics is the systematic use of data and related business insights developed through applied analytical disciplines (e.g. statistical, contextual, quantitative, predictive, cognitive, other [including emerging] models) to drive fact-based decision making for planning, management, measurement and learning.

Building analytics competency can help organizations harness “big data” to create actionable insights, set their future vision, improve outcomes and reduce time to value.

The daunting challenges facing the life science and healthcare industry today make for compelling arguments to expand the role of analytics. Evidence continues to mount that healthcare is increasingly challenged by entrenched inefficiencies, including wasting more than US$2 trillion annually. These inefficiencies can be attributed to several factors, including the ineffective gathering, sharing and use of information.

The increasing regulatory presence of government places additional focus on accountability, governance and oversight on the industry. Market dynamics and competitive pressures require enhanced nderstanding of underlying trends and a path to differentiation.

Using analytics to gain better insights can help demonstrate value and achieve better outcomes, such as new treatments and technologies. Analytics can improve effectiveness and efficiency. From managing small details to large processes, analytics can aid exploration and discovery; help design and plan policy and programs; improve service delivery and operations; enhance sustainability; mitigate risk; and provide a means for measuring and evaluating critical organizational data.

The multitude of volatile changes sweeping the industry is exacerbated by the proliferation of clinical information systems, electronic health records and connected health devices that have created an unprecedented information explosion. In the 2010 IBM Global CEO study, 93 percent of healthcare providers identified the information explosion as the biggest factor anticipated to influence their organizations to a large extent over the next five years.

The abundance of data that bombards healthcare and life science professionals both facilitates and complicates the ability to achieve and influence desirable outcomes. However, this wealth of information is a double-edged sword. The glut of information makes it progressively more difficult to distinguish between essential data and clutter.

In fact, the data paradox – the management dilemma presented by too much data and too little insight – is an increasingly daunting obstacle to creating effective analytics strategies.

The Relationship between Quality and Compliance

Fri, 30 Mar 2012 12:02:00 GMT

Quality is sometimes addressed as a seperate function of an organization, rather than integrated cross-functionally throughout a company. An overwhelming majority of companies we work with believe that maintaining compliance with FDA regulations does not ensure good product quality.

Executives that we spoke with indicated that they were aware of facilities that were highly compliant but produced low quality products or, the opposite case, products that were produced to high quality standards and achieved excellent performance but did not maintain good compliance standing.

In general, some of the Quality and Compliance executives agreed that achieving compliance in the “right way” (e.g., through a focus on mature, embedded quality processes) moves organizations in the right direction and may deliver a baseline level of quality. However, some thought it possible, and perhaps not uncommon, to achieve satisfactory compliance without installing mature, embedded quality processes.

Most companies define “quality” much more broadly than “compliance.” Quality is defined as products and services that deliver intended performance, safety, and customer satisfaction, while compliance is defined as meeting regulatory requirements. These concepts are quite distinct in most industry leaders’ minds and, in fact, are often embedded even in industry organizational structures where compliance and quality functions are separate.

Specific issues related to the regulatory regime concerned:

(1) an overemphasis on pure compliance versus quality outcomes

(2) barriers to implementing safety related improvements

(3) lack of enforcement specificity on highest-risk areas within the medical device space

The industry executives that we work with and have talked to emphasized the importance of culture in driving a quality mindset through their organizations. Companies that experience quality related issues in the past cited significant opprotunities to improve quality culture.

There is also the perception that the FDA has become highly focused on enforcement at the expense of cooperating with industry on delivering quality. Quality leaders indicated that an excessive focus on compliance often diverts resources and management attention away from investments in quality towards compliance activities like documentation, which do not directly lead to improved quality outcomes.

This is particularly true for smaller companies for whom adverse regulatory action could threaten their very existence.

In order to address the major barriers to quality that exist, companies should consider a comprehensive program centered on three parallel and overlapping agendas: (1) Aligning compliance focus to address industry quality gaps; (2) Enhancing transparency and visibility of performance to drive quality; and (3) Increasing industry engagement.

Click Here to Learn to Build Quality Control Checklists

A serious challenge is to deliver safe, profitable products on-time, every time. Integrated cross functionality between Quality and Compliances provides the oversight to get products to market while fully meeting regulatory requirements.

Six Simple Steps in Documenting Adverse Events

Wed, 28 Mar 2012 13:47:00 GMT

We received a lot of emails regarding Monday's blog article on Regulatory Reporting for Adverse Events. Regulatory and Quality Managers were asking what simple steps could their organizations and people implement to address the reporting for adverse events.

TRENDS IN ADVERSE REPORTING AND EVENTS

Each manufacturer must establish and maintain procedures for receiving, reviewing, and assessing complaints by an officially in-house or an off-site designated unit. Complaints concerning deaths, serious injuries, or malfunctions must be reported to the FDA. Companies must have documented or validated processes established for each of these situations.

To address that issue we've outlined a process that we use with our customers. Steps in a Corrective Action Procedure A corrective action procedure is not reworking or remaking an item to bring it back into specification. Patching up a mistake doesn't address what made it happen in the first place and it won't prevent a recurrence. A corrective action procedure can be documented using either a paper or electronic system.

The process for documentation is as follows:

Determine how much time should be allowed for a corrective action procedure (or CAPA response).
Decide who will investigate the problem, find a solution and perform the corrective action procedure.
Research and document the cause of the problem.
Plan how to keep the problem from recurring.
Communicate the corrective action procedure to everyone involved, at each appropriate level.
Periodically check to ensure the problem is solved and that the corrective action procedure was effective.

Inefficient Paper-based Electronic Document Control System

As companies grow larger and bring on multiple locations, it becomes more and more difficult to maintain paper-based or hybrid document control systems. These systems require tremendous effort to route documentation, obtain approval signatures, face-to-face meetings to discuss changes, and manual retrieval of documents during FDA and ISO inspections or audits.

Disconnected Document Control Processes

The more companies uses separate document control processes across departments and locations, the more likely communication breakdown becomes. Ineffective communication can lead to supplier problems, delays, warning letters and recalls from the FDA.

Specifically, manufacturers are required to establish and maintain procedures that will control documents and to designate one or more individuals to review and approve documents prior to issuance. Records of changes made to documents must be maintained, including a description of the change, identification of affected documents and signature of the approving individual.

FDA regulated companies that are falling behind are maintaining paper-based systems. Generating timely, accurate reports and trends using disparate tools (electronic spreadsheets, flowcharting software, paper documents in binders) can be time consuming and difficult.

Regulatory Reporting for Adverse Events

Mon, 26 Mar 2012 11:25:00 GMT

Regulatory reporting allows life science manufacturers to identify adverse events before they become critical issues, facilitating proactive risk avoidance and product regulatory and safety adherence, both now and as regulations continue to evolve.

Regulatory Complaint-handling Requirements

All complaints must be consistently handled in a regulatory compliant manner, according to a written complaint procedure of FDA. Failures to handle complaints in a uniform and timely manner can be cited as a nonconformance. In fact, the FDA often begins inspections this way because these records allow the agency to quickly assess whether a company‟s quality system and CAPA plans are adequate.

Each manufacturer must establish and maintain procedures for receiving, reviewing, and assessing complaints by an officially in-house or an off-site designated unit. Complaints concerning deaths, serious injuries, or malfunctions must be reported to the FDA pursuant to the Medical Device Records regulations. Companies must have documented or validated processes established for each of these situations.

What is or what is not a complaint?
The complaint procedure must identify what is and what is not a compliant. Customer calls that are not complaints should be documented as “NOT A COMPLAINT”, with the individual making that determination and date. This means that returned products, failed devices are complaints.

Effectiveness and Appropriate Documentation
An appropriate and well-designed complaint-handling system will provide the firm with a 360-degree feedback loop that can be used to quickly respond to consumer complaints as well as provide an opportunity for continuous improvement. Complaint files must be documented for no less than 2 years or from the time that is equivalent to products lifespan, either is better. An excellent practice, if associated with managing an MDR event, is the use of an MDR Checklist.

Achieving a compliant complaint-handling system
The effectiveness in handling complaints is based on honestly stating what can reasonably be done. While FDA requires the reporting and trending of certain categories of complaints, it is in the best interest of a company to closely monitor all complaints. In order for complaint handling system to achieve compliance.

DOWNLOAD REPORT ON REGULATORY REPORTING FOR ADVERSE EVENTS

Improving Patient Safety

Fri, 23 Mar 2012 12:13:00 GMT

According to a CNN report a new, experimental cholesterol-fighting drug is creating quite a buzz among researchers and other experts, prompting some to use words such as "dramatic," "breakthrough" and "game changing," to describe early-stage clinical trial results.

Other companies including Amgen, Merck & Company, Novartis and Pfizer, are also hot on the trail developing their own cholesterol fighting inhibitor drugs.

So what does it take to expedite not only clinical trials but the process of distilling a large quantity of newly enforced FDA requirements into a focused set of policies that accelerates innovation? The practices, procedures and systems a CLINIC adopts must maximize clinic operating effectiveness and proactively meet FDA requirements and expectations to minimize risk to patients.

Click here to read the case study

There is a wide variety and organizational differences in clinics and practices that affect the opportunity to achieve results quickly. Leveraging technology to streamline the clinical trial process is critical to pharma and medical device companies.

The difficulty of modern clinical trials can create a challenge for any pharmaceutical or medical device company and medical technology manufacturers looking to get their products to market as quickly as possible. The complexity of the international regulation system, as well as dwindling patient bases for clinical trials, is forcing the industry to look for new ways to maximize clinical operating effectiveness and development process.

Companies are in a critical stage where they need to adapt to new regulatory requirements that allow them to pursue new business initiatives quickly because without those expanded capabilities that tie into their clinical systems and processes, they will not have the competitive advantage.

Better implementation of IT could hold the key to making the long process of putting a medical product into the hands of doctors and patients quicker, more cost-effective and safer. Although progress has been made by big pharma and other industry organizations, there is still more that could be done to integrate IT into the mid-size pharma, medical devices and especially the healthcare world.

The expanded information technology capabilities can have significant top-line and bottom-line benefits that can help companies overcome immediate competitors. Companies with complex inefficient and impractical information technology systems and business processes typically are in fire-fighting mode.

In an environment tightly controlled by regulatory requirements, regulated manufacturers who are competing on a global scale, need to demonstrate that they can execute consistently.

The Perfect Storm - The Cost of Poor Quality

Thu, 22 Mar 2012 12:55:00 GMT

In a recent blog article in PharmaManufacturing titled Quality Circle: Profitability, Integrity and the Cost of Poor Pharma Quality, written by Bikash Chatterjee, President, Pharmatech Associates, writes “We can expect the U.S. market to experience continued change and consolidation with cost cutting remaining at the top of the priority list for big pharma".

"Pressure to be competitive in these new market opportunities is creating a sort of perfect storm.”

In a recent speech I gave at Pilgrim Software’s World-wide User Group Conference, where Business Intelligence Solutions was a conference sponsor, I spoke about what Quality actually means. Depending upon who you speak to, it can mean different things to different people in an organization and across the life science and healthcare industry.

But for the purposes of this conversation, Quality enables an organization to achieve the goals and objectives set out in its policy and strategy across its value chain. It provides consistency and satisfaction in terms of methods, materials, equipment, etc., and interacts with all activities of the organization, beginning with the identification of customer requirements and ending with their satisfaction, at every transaction interface.

Value chain is defined as the inter-linked activities, processes and production system in which all those steps where actual value is added in the product. It starts from the supplier and flows to the customer where all the non-value added activities, are tried to be removed.

PATHWAY TO GLOBAL PRODUCT SAFETY

During the last 3 years circumstances have changed for a lot of companies as a result of economic and global competition. As a result of those conditions, and the new FDA regulations which have introduced increasing complexity into internal business processes, a perfect storm has arrived which has delayed the pace of innovation and new product introduction.

Companies are in a critical stage where they need to adapt to new regulatory requirements and pursue new business initiatives quickly because without the expanded capabilities offered in “enterprise quality management systems” that tie into their business systems and processes, they will not have the competitive advantage across their value chain and geographic boundaries.

The expanded capabilities of an enterprise quality system can have significant top-line and bottom-line benefits that help companies overcome immediate challenges and take on future operational needs. A Quality System sets out the standards that you are working to, and how you are going to meet them.

The perfect storm of the modern business has undergone a seismic shift over the last several years. Economic conditions and transformations in the global technology market have resulted in a mindset that places much attention, allure and reliance on a flexible Quality strategy that can meet the fluctuating demands of the contemporary organization to lower costs, drive innovation and expedite time to market.

Two Top Challenges Facing Life Sciences

Tue, 20 Mar 2012 09:20:00 GMT

A survey of top life sciences organizations found that compliance issues and increased industry consolidation (via mergers and acquisitions) are the top challenges faced by companies in today's market.

As a result of the consolidation in the industry, the need to achieve compliance with worldwide regulatory standards is a major issue for organizations trying to maintain their competitive edge in global life sciences industries.

Professionals in the pharmaceutical, biotech and medical device industry said that varying supply quality standards and differing mandates across countries or regions are the greatest obstacles to managing quality and compliance

Moreover, increasingly global supply chains and greater industry consolidation are causing companies to re-evaluate their current practices and adapt to the changing industry landscape. Three-quarters of respondents said that they work with more than four global suppliers, with growing numbers of suppliers posing potentially significant threats to supply quality when not managed properly.

To drive bottom-line performance and competitive advantage begin with an objective, rigorous assessment of the current situation. Enlist the best critical thinkers and problem solvers in your organization. If this skill set is unavailable, get experts like Business Intelligence Solutions to help.

Identify how the system enable the company to automate their key quality improvement processes in the following areas:

Audits
Inspections
Issue tracking
Corrective actions
Supplier cost recovery
Document control
Reporting

Then identify and prioritize the Gaps. Regulatory requirements are constantly changing, especially in emerging markets. Identify the risk areas where processes are not sufficiently robust to consistently meet regulatory requirements. Anticipate reasonably foreseeable regulatory changes – perhaps based on changes already afoot in some regions – that could be proactively addressed.

A justification for a Quality Management System must address how the system will address three key issues – bottom-up operational management, top-down risk and cost management and financial ROI. We will address those issues in the next blog article - stay tune.

Developing The Business Case for Quality Management

Sat, 17 Mar 2012 11:47:00 GMT

I'd like to share a bit of good news with our readership, Business Intelligence Solutions blog is now syndicated on Boston.com! The Boston Globe received an overwhelming response and weren’t able to accommodate everyone, but they selected us.

We are also featured in OrthoWorld (medical device and analytical instrumentation) this month.

Now back to our regularly scheduled blog article:

Developing The Business Case for Quality Management

FDA Regulated manufacturer's face enormous challenges in managing their quality and compliance initiatives. Market trends point to greater scrutiny by the FDA and other government bodies as the pressure mount from consumers for manufacturers to deliver safer products and services.

To meet these important regulatory challenges, executives within bio-pharmaceutical and medical device companies have identified the need to implement a quality management system that automates processes and provides access to business intelligence data.

Many quality directors have difficulty in getting capital budget approvals to acquire a badly needed Quality Management System (QMS). The reason in most situations is that their justification approaches the system benefits from a bottom-up operational perspective.

The new system will provide a mechanism to achieve key quality objectives such as issue tracking, developing and implementing corrective actions and reporting on the key process improvement metrics.

While meeting these requirements enables an organization to standardize and automate its approach to quality improvement, it does not bring to light the key quality related issues that the senior management worries about.

Such topics include:

Getting access to scorecards and dashboards to get unprecedented visibility into the supplier quality to improve strategic supplier management
Implementing a mechanism to measuring, monitoring and reducing cost of poor quality and cost of compliance on an ongoing basis
Gaining a framework to manage enterprise risk from poor quality & compliance

In the following weeks, we'll be addressing some simple steps on how to determine the scope and size of your Quality Management implementation. We'll demonstrate how you can build a business case that outlines the return on investment senior management needs to understand that this is an imperative that will drive bottom-line performance and competitive advantage.

Conforming to Customers Needs and Expectations

Fri, 16 Mar 2012 12:22:00 GMT

CLICK TO FIND OUT WHAT ORTHOWORLD IS SAYING ABOUT US

A QMS must ensure that the products/services conform to customer needs and expectations, and the objectives of the organization.

Issues to be considered when settings up a QMS include are:

• Design

• Build

• Control

• Deployment

• Measurement

• Review

• Improvement

Taking each of these in turn:

Design and Build includes the structure of the quality management system, the process and its implementation. Its design must be led by senior managers to suit the needs of the organization, and this is ideally done using a framework to lead the thinking. Design of the QMS should come from determining the organization’s core processes and well-defined goals and strategies, and be linked to the needs of one or more stakeholders.

The process for designing and building the QMS must also be clear, with the quality function playing a key role, but involvement and buy-in to the system must also come from all other functions.

Control of the QMS will depend on the size and complexity of the organization. ISO is a site-based system, and local audits and reviews are essential even if these are supplemented by central reviews. Local control, where possible, is effective, and good practice is found where key stakeholders are documented within the process and where the process owner is allowed to control all of the process. Ideally, process owners/operators are involved in writing procedures.

Measurement is carried out to determine the effectiveness and efficiency of each process towards attaining its objectives. For a list of what objectives contribute to the QMS to the organization’s goals click here to download the new white paper -Two Important Requirements of Quality Systems.

A form of scorecard deployed through the organization down to individual objective level can be employed, and the setting of targets at all levels is vital.

Review of the effectiveness, efficiency and capability of a QMS is vital, and the outcome of these reviews Should be communicated to all employees. Reviewing and monitoring should be conducted whether or not

An effective QMS must ensure that the organization has a strong Customer Focus. Customer needs and expectations must be determined and converted into product requirements.

The understanding of the many interrelationships between these processes demands that a Systems Approach to management is adopted. The processes must be thoroughly understood and managed so that the most efficient use is made of available resources, to ensure that the needs of all the stakeholders – customers, employees, shareholders and the community - are met.

TWO IMPORTANT REQUIREMENTS OF A QUALITY SYSTEM