ISO Quality Systems Experts | Compliance Consultants

IMPLEMENTING A QUALITY ASSURANCE PROGRAM

Are you considering ISO Certification?

• Are you a manufacturer?
• Are you a distributor?
• Are you a service provider?

ISO Standards provide the foundational requirements of implementing a successful Quality Management System.

ISO9001  ISO13485  AS9100  ISO14000  API  QSC  NQA-1 

Every company is different – product, size, culture…

QUALACO utilizes a methodology that will work for your culture and your environment with the ultimate goals being:

1. Providing consistent processes with defined responsibilities
2. Driving Customer Satisfaction
3. Driving Continuous Improvements
4. Guaranteeing a Return on Investment

“QUALACO integrates ISO into the business process not business processes into ISO.  They do not simply develop an alien system that sits separately from the business.”

         K. Cassera, New Jersey

“QUALACO’s approach involves all parties in the business.  They ensure that the system is built with Management objectives in mind, but with feedback and input from those throughout the business”

         J Gardner, South Carolina

 With proper implementation ISO is a useful tool that may tell you something useful about your business and will, if implemented properly and embraced by the business, provide a real return on investment. 

NOT only do we optimize the process we remove non-value added activities to produce an immediate return on investment. Implementing processes using lean six sigma tools, created by our highly experienced Lean Six Sigma Black Belts; your entire QMS becomes a Black Belt project, with quantifiable results impacting the bottom line!

 Hmmm… what is the cost of implementing such a world-class system?

Well let’s look at it by first conducting a cost analysis, for example, we should begin by evaluating the cost of action against the risk of inaction. We must assess a problem’s financial implication before we expend resources on solving it. We should be able to identify the economic pain and, whenever possible, quantify it. For example, the cost to replace defective product might be minimal compared to the cost of implementing a corrective action plan. But before making a final decision:

 Maybe we should look at the Cost of INACTION

• What’s the risk of not responding to the customer’s request for corrective action?

• How much income does this account represent?

• How often has this happened, and what’s the likelihood of recurrence?

• What does it cost in time, labor and resources to replace the product?

• How will it affect the organization if the customer stops asking you to bid on new projects?

• What will this problem do to the organization’s reputation in the marketplace?

FAQ:

Are we required to use a consultant?

No, it is not required. And you don’t need a consultant to achieve ISO Certification.  Actually, many companies achieve ISO Certification on their own, by designating key employees to the task.  However, in this decision making process you must keep in mind ; that Consulting is ultimately  an exchange of knowledge and knowledge can come from different sources.  Many companies select a consultant because they have EXPERT knowledge and also want to efficiently implement certification within a reasonable time frame with guaranteed results from industry experts.  Unlike with allocating internal resources to achieve certification, the consequences of trying to implement a system on your own can be a set back to your business . Your  resources may be stretched too thin which can quickly outweigh any money saved by not hiring a consultant.  Not too mention that time is money, and the cost of re-work could be much more than you bargained.

What does it cost to hire an ISO consultant?

The rates vary. However, “you get what you pay for.”  Certain consultants can charge more because they have more experience and can help you effectively reach your target in a most efficient manner. Less time, less outlay of resources  project completed quicker, quicker return on investment. As in most professional fields, you are normally better off hiring a true expert. Would you hire one who trims trees, to trim your hair?

Or would you?

Just in time

 FREE ISO 9001 Quality Management System offering!

Presented by: Qualaco, Inc.

                                         Challenge with Significant Prize offering to Winner!

Economic woes have folks feeling the pain of the current times and lots of folks are out of work or struggling to stay afloat!

Small business, entrepreneurs, and particularly women business owners have been the backbone of our country for a countless number of years.

You may recall Rosie the Riveter, a strong, hard-working female figure during the testing times of World War II. Over 60 years later, these strong, confident, and positive women are needed again to improve the current job condition of this country. The time has come to bring Rosie out of hiding and make her the forefront of our drive to stimulate the economy.

We can make a difference; we can help someone in need “just in time” ! We are that good!

Yes, we have all felt the pain of this economic downfall in our own individual businesses. It has been slow, and at times, many have thought unsustainable. But we will get through this as all strong women have throughout the years. We have tenacity and moxy and drive. We will push for success.

We would like to set in motion a CHALLENGE to all of you business owners. A “Rosie to the Rescue, just in time” challenge!

Over the last year many of our corporate employees have been laid off, losing their jobs due to the downsizing of Big Corporate America. Some of these folks have had direct relationships with us and no doubt have helped many of us sell our product or service. They may have been buyers, supplier diversity managers, procurement managers, and the list goes on and on….

Now it may be our chance to give back, just in time.

The challenge is for all of you to put one person to work in December. Chances are you can hire an individual with outstanding experience and talent for less than what they usually should earn. That’s OK, if they accept. Folks need to work. If your organization does not have the funds, offer an independent contractor agreement. Strictly commission: you make money, they make money, and you create business that might not have been possible without offering someone that opportunity.

It may be said that the political climate has not been in the best interest of the small business owner, and there is definitely merit to that. But there are only 556 representatives wielding the power of that destiny “per se”. We can, as small business owners, have a significant impact on individuals and their families, and by the Grace of God, politics will begin to work for the small business owner.

QUALACO is offering this challenge with a Reward attached!!! Would you like to earn a QUALITY System compliant to ISO for your company!?

As quality consultants, that is what we will give to one fortunate company that accepts the “just in time” challenge. ROSIE to The Rescue!

Send an e-mail to rosie@isoqualitysystem.com stating that you would like to participate. State your story including how you contributed to Rosie’s Cause by placing one or more folks to work, just because you believe in the power of small business and woman entrepreneurs. Please keep it to a few paragraphs, and we will have a team of judges choose who should be awarded an ISO 9001 System, set up by quality experts.

If we all work together, we can make a difference in lives of those who need it. This is a considerable prize for those who want to make a positive contribution and join the initiative to move this economy forward, for everyone’s sake. God Bless! Good Luck, and please TAKE ON THE CHALLENGE! Do Rosie proud!

Healthcare Headache or Improvement Opportunity
Lean Six Sigma

As we move forward, the healthcare industry will be serving a double edged sword, and in an effort to reduce or eliminate the pain, the MAGNUMUS need for process improvement and quality metrics is ESSENTIAL. Specifically in these times it is necessary to eliminate non-value added items. Times are tough for all, and to reduce waste is paramount.

As the baby boom generation ages, the US will see the majority of its population in their senior years. Adding to the already short supply of medical professionals, the increasing services that will be needed, if not already overwhelming, will be out of control. To add to that, President Obama’s Healthcare plan, which is an overall positive effort to improve quality, will unfortunately increase regulation, policies, and constraints on the industry. Thus, causing another dramatic financial burden on all facilities. As some of President Obama’s goals stated that he wants provided are to:

ENSURE PROVIDERS DELIVER QUALITY CARE

Promote patient safety. Barack Obama and Joe Biden will require providers to report preventable medical errors, and support hospital and physician practice improvement to prevent future errors.

Align incentives for excellence. Both public and private insurers tend to pay providers based on the volume of services provided, rather than the quality or effectiveness of care.21 Barack Obama and Joe Biden will accelerate efforts to develop and disseminate best practices, and align reimbursement with provision of high quality health care. Providers who see patients enrolled in the new public plan, the National Health Insurance Exchange, Medicare and FEHB will be rewarded for achieving performance thresholds on physician-validated outcome measures.”

Process improvement consultants can design and implement real solutions that draw on an organization’s collective know-how to deliver proven results to healthcare organizations. Process performance improvement firms can and will provide value added consulting and implementation services that target bottom line results in quality of care, efficiency, patient satisfaction and organizational improvement. Returns on investments have succeeded 200%.

Many hospitals look inward to their own organizations, imbedded in the medical profession to make these changes occur. That may have some immediate benefit, but to embrace continuous improvement and to keep pace with the industry, it is necessary to look outside the box. GO LEAN with those that are experts in Lean Six Sigma, who just may have had their roots in manufacturing.

A sampling of what six sigma and process improvement firms can due for your facility:

Increased Patient Satisfaction and Care

Higher satisfaction scores
Fewer complaints
Reduced wait times and variation
Increased Physician Satisfaction

Fewer physician complaints
Dramatically improved throughput
Reduced scheduling delays
Reduced Costs / Cost savings

Better financials and higher annual savings
Less rework and waste
Better recruiting and retention power – both clinical and administrative
More efficient emergency departments
Fewer medical errors
Applying Lean Six Sigma Tools will eliminate the waste now placing you in a better position as our country’s demographics as well as government policies continue to change. Qualaco has the experience,knowledge and education to deliver a lean facility using six sigma tools, combined with thorough knowledge of ISO 13485 for procedural integration of processes. If you want to maintain 100% customer satisfaction and loyalty while streamlining contact.us@qualaco.com

November 23, 2009

Quinby, SC – November 23, 2009 – ATFC Inc., a specialized Tool & Die Facility and Sheet Metal Stamping Facility,  gained recertification to the ISO 9001:2008 standard for its facility located in Quinby, South Carolina.  QUALACO, Inc assisted them in this effort.  Global quality standards and requirements establish and enhance quality management systems through internal audits and development and improvement of procedures and processes.

“ATLANTIC TOOLING AND FABRICATING COMPANY INC. WAS ESTABLISHED IN 1985.  A TOOL AND DIE FACILITY WHO ALSO OFFERS SHORT-RUN AND LONG-RUN METAL STAMPINGS.  CAREFUL PLANNING AND CONTROLLED GROWTH HAS ALLOWED ATFC, INC. TO EXPAND ITS OPERATIONS AND TO BROADEN ASSOCIATED FIELDS OF APPLICATION, WHILE COMMITTING TO CONTINUAL OVERALL QUALITY IMPROVEMENT.  FROM INCEPTION ATFC, INC HAS EMBRACED INNOVATION AND MODERN MANUFACTURING METHODS”

About Qualaco, Inc.:

QUALACO, Inc. is a total quality management company that incorporates an immense knowledge base of best practices for industries, including, but not limited to, Automotive, Outdoor Products, Aerospace, Medical, Energy, and Nuclear. QUALACO assists businesses in developing, establishing and improving process controls, through internal audits, data mining and manipulations, which help to identify deficiencies in current procedures and processes. Business partners, Lori Lyerly, Lean Six Sigma Master Black Belt, and Marie Giordano, Lean Six Sigma Black Belt, co-founded QUALACO in 2007, for the purpose of helping businesses establish best practices to maintain a total quality managed company. For more information, visit QUALACO, Inc., on the web at http://www.Qualaco.com

Media Inquiries Contact:

Candace Runaas

Runaas Resources LLC

281-257-4431

contact.us@qualaco.com

Certificate Presentation

Spring, TX – November 2, 2009 – Qualaco, Inc. certified Hooks Industrial Inc., an international engineering, industrial and distribution company, to the ISO 9001:2008 standard for its facility located in northwest Houston. Global quality standards and requirements establish and enhance quality management systems through internal audits and development and improvement of procedures and processes.

The six month quality evaluation finalized formally with receipt of certification in October 2009. Hooks Industrial is a supplier and distributor of pumps, compressors, turbines, control valves, mechanical seals and replacement spare parts to the nuclear, oil, gas and energy industries.

About Qualaco, Inc.:

QUALACO, Inc. is a total quality management company that incorporates an immense knowledge base of best practices for industries, including, but not limited to, Automotive, Outdoor Products, Aerospace, Medical, Energy, and Nuclear. QUALACO assists businesses in developing, establishing and improving process controls, through internal audits, data mining and manipulations, which help to identify deficiencies in current procedures and processes. Business partners, Lori Lyerly, Lean Six Sigma Master Black Belt, and Marie Giordano, Lean Six Sigma Black Belt, co-founded QUALACO in 2007, for the purpose of helping businesses establish best practices to maintain a total quality managed company. For more information, visit QUALACO, Inc., on the web at http://www.Qualaco.com

Media Inquiries Contact:

Candace Runaas

Runaas Resources LLC

281-257-4431

info@RunaasResources.com

or

Marie Giordano

Qualaco, Inc.

281-919-1643

Marie.Giordano@qualaco.com

Focusing only on procedural writing for a Quality Management System will result in slower processes, re-work, and an overall uneconomical system:

Quality Management Systems, such as ISO 9001, serve as the foundational building blocks for an organization and provide well defined and documented procedures which improve the consistency of outputs. Yet, the Quality Management System alone cannot accomplish a system of closed loop corrective actions and instituted lessons learned.

A clearly defined and successful Lessons Learned Program will lead to the development of a closed loop corrective action system. Without this closed loop, there are no true lessons learned. Imagine the list of 5000 items on an excel sheet, titled “Lesson Learned.” As with any business, time is money. How can it be cost effective for an individual to spend hours sifting through a bulky excel sheet. It cannot and is not. Capturing the essence of the lesson and identifying communication channels is the key to closing the loop.

Proper investigating and reporting of mishaps (safety incidents, equipment failure, quality issues, etc) will actually be the driving factor for the successful Lessons Learned Program. This can only be achieved through the use of proper incident investigation and advance root cause analysis. Because without the identification of the true root cause, what is the lesson that is to be learned.

Reporting criteria for mishaps must be established to allow for proper screening. Without the screening criteria set, there will be no consistency in the process. Consistency can only be achieved by a well defined and documented process.

Investigation is the next key step to the successful Lessons Learned Program. The utilization of an advanced root cause methodology will drive you to the true root cause of a mishap. Advanced root cause analysis, such as TapRoot or Reasons, allow the user to utilize a systematic approach for finding the true root cause, so that corrective action can be initiated and the lesson truly “learned” and fixed.

Lesson Learned can be a very extensive and lengthy process to establish. But there is one approach that can be taken to alleviate this issue. This approach is what businesses should consider in developing all documented processes, procedures, and workflows. This approach is Lean Six Sigma. Alone Lean initiatives will not accomplish this, nor will Six Sigma alone. Together they can build the most cost effective and efficient Quality Management System.

As with the development and maintenance of all Quality Management Systems, processes are evaluated and documented. Consider first Six Sigma, which seeks to improve the quality of process outputs by identifying and removing the causes of defects. In order to establish a clear effective procedure, potential for defects must be considered. This consideration will lead to the development of processes and a system that seeks to eliminate the defects. Secondly the Lean factor focuses on eliminating non-value added “waste” in the process. This elimination will lead to efficient procedures that reduce the overall process cycle time which will improve delivery performance and will most importantly reduce costs.

The effectiveness of a Quality Management System is overall dependent upon the ability to effectively establish and document procedures:

• Without effective documentation, you are left open to a redesign of the process every time it is performed. Effective documentation will allow for monitoring, managing, and improvement.
• Monitoring, measuring, and improvement will be accomplished with the well built Lessons Learned System.
• All of these must be created in parallel.
• It provides a unique approach to creating a system that will be successful.
• The reality is that most will take a one way approach.
• This may be somewhat successful, but in order to drive a system that does eliminate defects and potential defects one must consider all.
• Without a Lean Six Sigma approach there is no true evaluation of what will create a Quality System that will eliminate the possibility for defects.
•  Without a Quality System there is a loss of consistency, time, and money.
• Without out a true system of Lessons Learned there is no true path on closing the loop on any mishap or corrective actions.
• Without advanced use of a Root Cause Methodology one may never be able to drill down to the true root cause, leaving the possibility of repeat failure.

The best possible avenue in the development of the required principles and tools of a Quality Management System is to utilize a professional team of individuals experienced and trained in Lean Six Sigma and Advanced Root Cause Analysis. This experience coupled with vast ISO Quality Management System and Systems Auditing experience will lead to successful project implementation and completion.

QUALACO, Inc is a business process improvement company grounded in Lean Six Sigma principles and Total Quality Management. QUALACO brings their unique approach into organizations to guide and assist in implementing an entirely successful Quality Management System; a system custom designed to meet the needs and requirements of the organization.

“QUALACO, Inc is committed to providing quality services which conform to customer specifications; completed in a cost effective manner with on time delivery”

ABOUT THE AUTHORS

Marie Giordano

Marie Giordano is the co-founder of QUALACO, Inc., a Total Quality Management Consulting firm, specializing in process performance Improvement. She manages the direct daily business operations for the firm, and is directly responsible for managing its client base and overseeing projects that directly relate to Process Performance Improvement, ISO Systems Development, Supplier Quality Audits, and Root Cause Analysis Program Development. Mrs. Giordano is highly educated and experienced in advanced root cause analysis methodologies.

Lori L Lyerly

Lori L. Lyerly, MBA is the co-founder of QUALACO, Inc., a Total Quality Management Consulting firm, specializing in process performance improvement. She manages the direct daily business operations for the firm, and is directly responsible for managing its client base and overseeing projects that directly relate to ISO Systems development and maintenance for all ISO Certification types, Supplier Quality Audits, Internal Auditing Systems & Training, and Statistical Process Control Development. Ms Lyerly is a highly educated and experienced in Quality Control Management