With more than two decades of executive leadership experience in the enterprise software industry, Eileen believes that innovation is key – so it comes as no surprise that she continues to innovate at Sparta to ensure that the company continues to lead the market in enterprise quality and compliance management solutions. 

Eileen has also been named a finalist in the Ernst & Young Entrepreneur of the Year 2012 program in the New Jersey region. She was recognized for her excellence and success in areas of innovation, financial performance and personal commitment to business and the community.

The award winners will be announced on June 27 at the Hyatt New Brunswick. Will you be in attendance? If so, please be sure to say hi to any members of the Sparta team you come across.

As Sparta continues on a path of growth and success, we’re honored that Eileen is leading the way, and is being acknowledged for all her efforts.  We expect this to be the beginning of many more to come!

Members of the global medical device community hope this leads to greater trust among regulatory agencies, and a reduced number of audits and inspections by them in the future.

But does this proposed document also include elements that might be used by medical device manufacturers themselves?   One very powerful element is a “grading system [providing] a common risk based approach.”  This improves upon previous categories of major and minor audit nonconformities by providing for five levels.  

- Indirect QMS Impact, related to ISO 13485 sections 4.1 through 6.3, versus

- Direct QMS impact, related to sections 6.4 through 8.5, and

- First time occurrence, versus

- Repeat occurrence, and finally

- Escalation, if there is

    – no associated documented process or procedure, or

    – a nonconforming medical device has been released to the market

In addition to the grading system, there’s a standard reporting format.  In addition to ISO 13485 nonconformities, there’s also a provision for documenting country specific regulatory requirements above and beyond the requirements of ISO 13485.

There are multiple examples in the Appendix of the proposed document which are useful for further understanding.

What do you think?  Are these elements something your company could use for internal and supplier audits?  Will this drive change in common audit practices?  In any case, as the GHTF transitions to the International Medical Device Regulators Forum (IMDRF), this is certainly one initiative to monitor closely.

Related Links:

GHTF proposes standardized approach to QMS nonconformity issues

New Audit Form for Medical Device Regulators

The IAF Initiative for Accredited Certification to ISO 13485 – Medical Devices

Outcome Statement of the IMDRF Management Committee 28 February to 1 March 2012

Sparta Systems is proud to have donated 63 laptops when the organization’s co-founder and president, Ted Knapp came to our headquarters. Since its inception in the spring of 2008, WVFV has been honored to help close to 500 Veterans transition from military life to a civilian career by garnering the “Vessels” they require. Their mission is simple…To thank our service men and women by helping them along their next career path. Sparta Systems is honored to have been able to help. Check out a few pictures and a short article on WVFV’s site.

Companies have been collecting business related data in various forms for decades. It used to be that collected information was sorted and stored in giant databases collecting virtual dust until needed and analyzed using business intelligence software. This data was not always useful – often dependent upon on when it was analyzed and read. Thus the information was not always timely.  Organizations realized that they were making decisions based on ‘stale’ data instead of using information as it happens.[1]

This is what is happening now with infrastructure and technology to ‘stream’ live data, integrated with advanced data analytics systems and techniques coupled with delivering the relevant and appropriate information to the right person in a format that is conducive to effective decision making. This allows companies to link multiple stakeholders, both internal and external, to what is happening now. This is data talking to data in real time.

Many industries improve their operational efficiencies, foster better customer and supplier relationships and improve customer satisfaction and retention by utilizing these technologies. Nowhere is it more relevant than in the advanced manufacturing and supply chain of the electronics industry, as more markets around the developing world have increased their appetite for better, faster and more advanced devices. This demands newer products faster and cheaper. Therefore, the electronics manufacturing sector has embraced real time management using systems to effectively and efficiently manage tasks that are cross-functional in nature and involves both outside manufacturing and global supply chain.  Below is a  great example that illustrates this real time data management.

Let’s say at the final assembly of a product, a critical problem that could cost the reputation of the product is discovered. Initial triage of the deviation finds the problematic part and a full investigation that includes the supplier of the offending part is implemented. This leads to an amended inspection process, a corrected method for final packaging of the part and training of the personnel at the final assembly site. While this process goes on, another factory is notified of the findings, resolution and new processes while another group analyzes the previously completed lots for any anomalies by way of sample testing. All these steps go on in near real time while making sure the information is processed while maintaining the proper yields and minimizing errors – leading to higher quality output to the hands of the customer.

This example is just the tip of the iceberg and helps illustrate why electronics and high tech manufacturing put trust into TrackWise Enterprise Quality Management Solutions. It’s a platform that is integrated with their ERP, MES, CRM, SCM and other enterprise pillar applications, which helps them produce the high quality, safe products their customers expect, while increasing operational efficiency that yield greater revenue and profits to the shareholders.

Source: Wall Street Journal, 04/02/2012

Everyone interprets risk-based validation differently, yet most companies generally look to leverage documentation created by the vendor to help reduce the burden of testing.  The main challenge with this approach is making sure that there is enough objective evidence to support a validated state.  Have you audited your vendor?  Do they have acceptable processes and procedures in place to assure trust in their validation processes and documentation?  The proper vendor documentation can reduce your validation burden by providing you with objective evidence, including IQ/OQ test scripts, requirements documents, and validation reports.  You can then perform an impact assessment to determine what level of additional testing is needed.

Even with best practices based systems, it is impossible for vendor documentation to provide truly turn-key Performance Qualification/User Acceptance Testing (PQ/UAT) documents because the goal of this part of testing is to confirm that the system meets all requirements from the user requirements specification (URS), an inherently internal document.  Any PQ/UAT documentation provided by a vendor should be utilized as a template and a starting point to build your company’s specific URS and SOPs.  No vendor has the ability to test a customer’s SOPs to ensure that the end users can perform the system functions and processes, which is a key step in PQ/UAT testing.  Differences in each customer’s product offerings and manufacturing and quality policies inevitably result in deltas that must be accommodated in validation documentation.

Most vendors offer materials that help reduce validation efforts while still leading to a compliant system, yet there are some software and service providers that offer validation products that bring in revenue for their company without helping their customers achieve true compliance.  Certain vendors have validation products that compile and run test scripts for each set of requirements with just a single click.  While it certainly sounds like a simple, attractive solution to validation, there are several questions that beg to be asked. How do the reports that are run in the system map back to the original user requirements?  If the system is self-validating, how can it possibly fail?  Just because a process can be completed from start to finish does not mean the process is correct for the task at hand.  When the validation passes, how do you capture the data to prove it and provide objective evidence?

Generating test scripts from the system based on configuration rather than from the URS is certainly suspect and borderline noncompliant; and it is simply impossible for a vendor to test for intended use and system administration since these factors are based on the company’s procedures.  Furthermore, self-validating systems also present an issue when it comes time to maintain validation as system configuration changes.  If the system has validated itself, how can validation be done to test any changes to the configuration without starting from scratch?  While there are plenty of realistic and professional vendors looking to help their customers by providing effective documentation, products, and services to support validation efforts, companies must be careful to avoid the pitfalls that can lead to systems that do not fully meet the specified requirements and can create regulatory exposure.

The Role of Enterprise Quality Management Software in CPG

EQMS typically allows an organization to centrally manage and automate critical processes for ensuring compliance and quality across the enterprise. Core capabilities of EQMS generally include but are not limited to:

- Non-Conformances / Corrective and Preventive Actions

- Audit Management

- Change Control

- Sampling and Testing

- Quality Planning

- Supplier Quality Management

- Risk Management

- GMP and HACCP

In the CPG industry, these capabilities are just as important as they are in the life science or electronics manufacturing industries; it is just that they are much more likely to be managed through home grown disparate databases or purely paper based systems. If you would like to learn more about EQMS in general please follow this link, but there are some specific benefits of EQMS to the CPG industry that should be called out here:

- Improve finished product quality

- Lower the cost of quality

- Improve manufacturing efficiency

- Improve supplier performance

- Build quality and compliance into production processes

- Create collaboration between research and development and manufacturing on quality

- Improve the success of new products being introduced to the market

- Provide visibility into key quality indicators

Experience has proven time and time again that adhering to best practices in change management, culture, executive sponsorship, and proper planning often are just as important as the the technology itself. For these reasons following the below three steps can have a tremendous impact on the success of deploying EQMS in the CPG space.

Step 1: Make quality an executive priority and start changing the culture towards one of continuous improvement. Far too often grass roots efforts start out with a lot of momentum but if the executives don’t believe in it the trend is more often than not for the initiative to lose steam and not have a truly enterprise wide benefit.

Step 2: Begin to harmonize disparate systems and business process into a standardized and flexible framework for creating operational excellence and building quality into the business. Many companies today just have too many systems and they are often disjointed and difficult to maintain. By streamlining the IT environment and focusing on business process quality can begin to become a strategic objective that is intelligently built into business processes.

Step 3: Support changing culture and business process with an Enterprise Quality Management Solution that centrally manages core quality capabilities. With the executive sponsorship, culture, and business process pieces of the puzzle figured out, it is time to start moving on to software. This software should be designed to centrally manage quality and compliance across the business and start with well proven core capabilities like those listed above.

EQMS in the CPG Industry

In the CPG space it is all about innovation, growth, and building billion dollar brands. Unfortunately, for many CPG companies, quality and compliance have not yet been an area of focus or investment – but this is starting to change. As CPG companies want to protect the brands they have, grow into new markets, and become more efficient, they are realizing that centrally managing quality as a key executive priority can be a strong competitive advantage. These companies are learning from other industries (like life sciences), and are now focusing on executive leadership around quality, creating a culture of continuous improvement, building quality and compliance into business processes, and supporting it all with an Enterprise Quality Management Software deployment.

At a high level, the CPG industry ranges from companies that produce food, to cosmetics, to diapers, to soap, to razors, to batteries; and everything in between. The CPG industry is also dominated by large global companies like Proctor and Gamble or Unilever and for these companies to compete effectively it is all about building scale and Billion Dollar Brands.

To successfully build and grow these brands, CPG companies typically take a portfolio approach to managing their brands and focus on strategies that enhance brand loyalty, spark innovation, or help open new global markets. Although once a company has effectively built a brand, and often even before, effort and resources should also be allocated to preserving brand equity and managing the risk of non-compliance, poor quality, or recall type events.

Managing Risk to the Brand

A quality issue, non-compliance event, product recall, or consumer safety issue can all critically impact a brand if not handled properly. The impact is almost always revenue first but if risk is not properly mitigated and quality is not managed well, the impact can quickly become a brand issue as well, which is much more damaging in the long run.

A great example of how having a good quality system in place can save a brand was the 1982 recall of Tylenol products from the shelves. This recall immediately hit the company for over $100 million dollars of products being pulled from the shelves but because J&J quickly and honestly communicated to the public that their quality systems were up to the task of remedying the situation the revenue hit was only short term and the brand survived.

A more recent example again comes from a related industry, automotive. In 2009 Toyota had to recall huge numbers of cars after multiple crashes and deaths because of unintended acceleration hit the mainstream media. In this case it probably can’t be argued that executives handled the situation in the best way possible but again it can be argued that because of the public’s belief in quality management at Toyota the recall was only a short term hit to revenue and not a long term hit to the brand.

But the question is if CPG companies have made the same investments that Life Sciences or Automotive companies have. Unfortunately, for many companies, the answer is “No” at CPG companies and it is time to start focusing on a lack of supporting quality systems as a major risk to the company. Luckily, as more and more CPG companies have become large conglomerates it is not uncommon for the same company to have a Life Sciences arm and a CPG arm. At these companies, we are starting to see a sharing of best practices across divisions and the roll out of Enterprise Quality Management Software (EQMS) at these companies.

Stay tuned for next week’s part II where we will explore the role Enterprise Quality Management Software (EQMS) can play in addressing the challenges above.

Unfortunately, nothing seems to be as easy as it used to be. Delivering a product to market today requires a complex and distributed value chain; involving many different companies all with different responsibilities, including: engineering, manufacturing, supply chain, customer service, compliance and more. In such an environment, quality management has been forced to move beyond just the four walls of the plant or the quality department itself. Suppliers and customers now need to be brought into the fold and this can only be accomplished if companies take specific steps in how they manage their people, business processes, and technology.

People

Leading companies take quality seriously and it starts right at the executive level. Executives set the tone and a passion for quality should flow throughout the organization. Leading companies also believe in collaboration and communication. Quality is not viewed as a department but a shared responsibility that everyone takes pride in. Finally, there is a general belief in leading companies that the continuous improvement process is important, valuable, and a key factor in the success of the organization. These companies are not satisfied and are always looking for ways to get better.

Business Process

Improved quality is often about improved decision making, and making better decisions does not happen by accident. Leading companies have invested in the systems that help them standardize business processes so that the right information is delivered to the right decision makers at the right time. In the spirit of continuous improvement, these processes are also designed to be flexible so that as new best practices emerge the processes can evolve as well. Finally, companies should not be forced to continually reinvent the wheel. It is often the best approach to use automated workflow and alerting tools to build these processes, which is discussed more in the next section.

Technology

To help support all of these quality initiatives across the organization, more companies than ever are deploying Enterprise Quality Management Solutions (EQMS) to help harmonize systems and manage data centrally. This creates a single view of the truth and allows all parts of the organization to have a clear picture of quality in the organization. In regards to supplier management, top performing companies are also extending EQMS to include Supplier Quality Management (SQM). These systems allow companies to do more than just tradition supplier ratings or the collection of supplier test data; they provide web-based portals and collaboration tools to allow the real-time exchange of information between parties. Ultimately, creating a stronger relationship between companies and improving overall supply chain quality. Which all sounds well and good but does leave one big question?

Will Suppliers Agree?

We often get the question:

“I get it that SQM this will help us gain a better understanding of our supplier’s quality but will they agree to provide me this level of detailed information?”

This is a valid and often very important question to the overall success of a supplier quality initiative. In our experience, the response of a supplier can be mixed and it usually all comes down to trust and personal relationships. If the supplier does not trust the usually larger and more powerful retailer or brand owner then the initiative is in jeopardy from the start. However, if there is trust, and the supplier believes such an initiative is not just cost cutting but will help improve performance and create more of a collaborative partnership, the initiative is usually well received. So, from our perspective, suppliers will agree if it is positioned correctly. But of course, with all relationships that depend on trust and personal connections, starting small and building on past success is usually the best approach.

The seminars were intended to help local industry leaders gain an understanding of the approaches to quality management and assist them in developing, implementing and managing cost-effective Quality Management Systems. Core presentations were given by Jon Reich, Information Systems Manager for Synertec Asia, who discussed how to ensure critical Quality Management System processes are effectively managed, and how to assist your organization to reduce the cost of compliance. Matthew Kopecky, Director of Sales Support for Sparta Systems explored how Enterprise Quality Management Systems allow seamless integration of quality system processes, reducing cost and risk, and ensuring regulatory compliance.

In Malaysia Jon and Matt were joined by Rohani Mohammad, Director / Principal Consultant – Neoconsult, who provided real world examples and case studies from Malaysian companies implementing quality management systems. They were also joined by Thomas Halfmann, Managing Partner & Principal Consultant – HGP, who presented on gaining a greater understanding of IT system quality and compliance requirements, and practical solutions for reducing the cost and effort associated with their management focusing on computer systems validation.

What constitutes ‘substantial equivalence’ and a ‘predicate device’ is key for any device company as they bring next generation products to market.  This draft guidance is intended to replace prior revisions from 1986 and 1998 to reflect current thinking in the agency with modern technology and represents a window into the future of the device industry.  As such, this draft guidance is something that every device professional should seek to understand and monitor in the coming months to get a head-start on what’s in store for the industry.