You only need look no further back than the recent woes of Toyota to realize that although overall automotive industry quality continues to improve, internal failures of automotive quality management systems within an organization can still drastically affect a brand’s reputation and thus its sales.

The industry has been plagued over the years with quality management system shortfalls that have lead to the deaths of hundreds of people and the recall of millions of vehicles for safety-related issued. In many cases, profits have been the driver behind quality failures in the industry.

Since quality is a driver of safety, it stands to reason then that in order to improve safety and reduce the number of recalls mandated by the NHTSA and thus the reputation of the industry, auto industry leaders must re-evaluate their commitment to quality, and look back at the industry to find similar failures and avoid repeating them.

The Top 5 Automotive Quality Management System Failures

1. Ford Pinto and Mercury Bobcat (Model Years 1971 to 1976)

In order to compete with burgeoning Japanese imports, Ford Motor Company mandated the production of a car that would cost no more than $2000 and weigh no more than 2000 pounds. The result was the Ford Pinto and its cousin the Mercury Bobcat. As the car neared production, engineers discovered that it failed rear end collision tests miserably due to the location of its fuel tank between the rear bumper and rear axle. Despite being made aware of the problem, Ford management decided to leave the car as is, electing to bear the cost of any lawsuits versus spend the $11 per car to fix the problem. In 1978, after over 100 deaths caused by fuel tank fires were reported due to rear end collisions, the NHTSA recalled 1.4 million Pintos and Bobcats to modify the fuel tank. Ford’s reputation suffered terribly, being seen as the company that put profit ahead of safety, and drove even more buyers to imported cars, the purpose for creating the Pinto from the start.

2. Various General Motors Models (Model Years 1997 to 2003)

Although it had been producing and heavily utilizing its 3.8L V-6 engine for decades, General Motors was forced to recall 1.5 million vehicles due to engine fires that could ignite when oil dripped onto the exhaust manifold during hard braking conditions. An oil leak in the engine could catch fire when exposed to the hot manifold, melting a plastic spark plug wire retainer located directly overhead. The plastic can ignite, resulting in a full-blown engine compartment fire. The NHTSA issued the recall in 2009, six years after the last model was produced. Ironically, General Motors is recently recalled almost half a million Chevrolet Cruze’s for a very similar problem.

3. Ford Explorer (Model Years 1991 to 2001)

Ford owed much of its profitability in the 1990s to the popularity of it’s SUV icon, the Ford Explorer. But it was quickly discovered that the Explorer was top-heavy, tending to roll over during emergency handling maneuvers. The problem was not enough of an issue in and of itself to cause Ford to re-evaluate the Explorer. However, many were outfitted with Firestone tires, which had their own tread separation issues. When combined, the unstable vehicle and faulty tires lead to the deaths of over 200 people. Ford recalled Explorers in 2001 to replace more than 6.5 million faulty tires. Despite the fact that the Explorer was redesigned in 2002, it never regained its dominance in the SUV marketplace.

4. Ford Various Models (1988 to 1993)

In 2002, Ford was court-ordered to recall 7.9 million cars and trucks due to a faulty ignition module. The module’s location on top of the distributor would cause it to overheat and fail, causing cars to stall and lose control of steering and braking. Ford was aware of the problem, but rather than relocating the module to a cooler location at the urging of their engineers, they chose instead to beef up the module to make it last just long enough to exceed the warranty period, forcing owners to bear the cost of replacement. The module had been installed on over 22 million Ford cars and trucks, but by the time the recall was issued, only about one-third of them remained.

5. Toyota Various Models (2005 to 2010)

Removable floor mats were identified as the cause of Toyota’s recall of 9 million cars in the U.S. The floor mats were found to move and wedge the accelerator in position, causing it to stick and lead to a potential crash. When the recall was announced, 52 deaths had been attributed to the issue. Despite proactively cancelling the sales and production of the recalled models, Toyota’s reputation as a quality leader was damaged.

There have been many other image-damaging recalls over the years that did not make the list but deserve some notation.

The Runner Ups

General Motors’ X-cars were recalled 13 different times over the course of their short two year life for a variety of safety and mechanical issues.

The Plymouth Volare / Dodge Aspen were recalled a total of 8 times, and were notorious for premature body rusting and mechanical failures.

And the Audi 5000, despite much lower total recall numbers, suffered the same flaw as Toyota with a faulty floor mat causing the accelerator to stick. The drop in sales due to bad press from the “unexpected acceleration issue” almost caused Audi to close its doors.

In all of these cases as well, the reputation of the manufacturer suffered, and it has taken them years to recover from their shortcomings.

The post The Top 5 Automotive Quality Management Failures of All Time appeared first on CEBOS Quality Management Software.

In the pharmaceutical industries, quality refers to the identity, strength and purity of a product which relates to its safety and effectiveness. The public relies on the integrity and accuracy of pharmaceutical and cosmetics’ labeling and instructions to protect them from harm. Current Good Manufacturing Practices (CGMP) established quality standards within these industries to ensure products are safe and deliver the intended benefit or result. CAPAs, or Corrective and Preventive Actions, are processes used to investigate, identify and correct non-conformance as part of the CGMPs.

Regulations

The Food and Drug Administration regulates the manufacture, production and approval of these types of products. While it imposes strict guidelines, how a company regulates itself to adhere to the standards and its own internal processes leaves room for variation and error.

Industrial manufacturing and service industries can achieve ISO 9001:2008 quality system certification or some industry specific variation of the ISO 9001 standards in order to conform to globally accepted quality standards. In the United States, the FDA has established current Good Manufacturing Practices, or CGMPs, which outline quality system standards for food and drug manufacturers. CGMPs are not new or additional regulations for these industries. Rather, they establish standards for a quality system for these manufacturers similar to ISO 9001:2008.

The CGMPs are similar to ISO quality standards.

There are four major sections:

1. Management Responsibilities — As with ISO 9001:2008, management has overall responsibility for the establishment and support of the quality management system. They provide the resources, leadership and support within the organization for the establishment and maintenance of the system. They also are responsible for management review.
2. Resources – Management is responsible for providing the proper facilities and equipment to process and manufacture products according to specification and quality standards. The quality system also establishes guidelines to acquire and receive materials and for processing materials for use. It also provides for proper laboratory facilities and equipment to properly test and approve product samples and a system to document and affirm results. Qualified, trained personnel to perform all operations are another vital resource.
3. Manufacturing Operations – Quality systems rely on the proper design, development and documentation of manufacturing operations systems, procedures and work instructions. Once established, there must be a process for controlling documentation, updating for quality improvement and ensuring documents and electronic systems are secure and controlled.
4. Evaluation Activities – Corrective and Preventative Action (CAPA) is a well-established quality process that seeks to identify the root cause of deviations in quality process and product non-conformance to eliminate the cause and prevent further occurrence of the same or a similar situation. CAPA uses a closed-loop process to identify the source of a non-conformance and establish a plan of action for closure. Root cause analysis can involve customer complaints, end-users, vendors, workflow management, the training and experience of operators, reliability of documentation, quality of internal audits and the corrective and preventive action system itself.

Whether the CAPA system is electronic or manual, a reliable CAPA system is a vital component to CGMPs and ensuring the quality and integrity of manufacturing processes and products under FDA regulations.

The post Current Good Manufacturing Practices and CAPA appeared first on CEBOS Quality Management Software.

Document control and management are vital to achieving and maintaining compliance in regulated environments. Forms and procedures must be accessible to those requiring them at any time, while critical records, including non-conformance reports, test analyses, and audit results, must be strictly controlled to prevent unauthorized access and modification or deletion. In many cases, document control is a full-time job for one or more employees within a business.

To help streamline the document control system, many companies have developed document control software that allows an organization to maintain and control access to its documents. Whether or not a small business should invest in document control software depends to a large extent on the complexity of the quality management system in place, the number and relative availability of employees to perform the task, and the end product of the business. Document management software is not needed in every organization, but for most, it can be a helpful addition, if not a direct contributor to the bottom line of the business.

Document control software can be as simple as a stand-alone repository for a business’s policies, procedures, records, and documents, or as complex as a fully integrated application with notifications through email systems.

It can route documents for review and approval, send reminders of corrective actions overdue, assign new corrective actions, notify employees when training is required, and notify quality managers when equipment calibrations are due. The system can be housed completely internally on one PC workstation, or stored externally on a client-based web application or in a cloud environment.

When a document control software solution is properly designed and implemented, it can provide a return on investment for a business. By carefully selecting and deploying components of such a system, administration of a document management system is drastically reduced, freeing employees formerly tasked with the responsibility to take on other responsibilities within the organization, thereby eliminating overhead. In some cases, it may be possible to reduce total organizational headcount.

Document searches can be completed quickly, saving time. Moreover, it improves the accuracy and reliability of the storage process, and can decentralize the system to allow users remote access to procedures and documents, improving the productivity of an organization.

Before any business, large or small, decides to invest in document control software, it should carefully assess its current document handling processes, and determine, in detail, exactly what it expects of a document control application, as well as its current electronic storage capabilities.

Small businesses will likely be successful with an existing off-the-shelf application and a single dedicated PC, while large companies may need to invest in customized software and a server, or contract for off-site data storage. It is critical for both simplicity and cost management to only purchase those portions of a system which are useful and add value to the organization. Investing in a large suite of document control modules that do not fit the needs of the business is wasteful, and overly complicates the software, training, and end use of the product.

Businesses investing in document control software should look for an application that is scalable with the business. Applications that can be integrated into an existing office suite are preferred for training and compatibility reasons, but are not necessary. Independent applications may afford the business with more capabilities, such as email reminders and automatic scheduling and approval routing. Regardless of the application chosen, it should have the ability to sign documents electronically, provide access control and password protection, and create an audit trail that can easily be followed for internal and third-party audits of the quality management system.

Small businesses will find that document control software applications exist in abundance that integrate easily with Microsoft Office and other business software suites. Some of the applications also exist as shareware or freeware, making their cost to the organization nil. In many cases, the same small business can use a stand-alone PC to house the application, and designate an individual within the organization to perform daily or weekly database back-ups to DVD for storage off-site or in a fireproof safe for records retention and business continuation purposes.

An independent PC with document control software also prevents hacking from outside intruders, and can be programmed for individual password access to specific documents and forms housed on the unit.

An investment in this type of hardware and software will be relatively small and affordable for the small business and will produce quick return on investment (ROI), yet will still enhance the quality management system requirements for document control and storage while at the same time allowing employees to be quickly trained to begin using the system.

The post Should a Small Business Invest in Document Control Software? appeared first on CEBOS Quality Management Software.

It is designed to help businesses ensure that they are meeting the needs of their customers and shareholders. The system is published by the International Organization of Standards (ISO), and deals with the fundamentals of quality management as well as the eight management principles on which they are based.

ISO 9000 was first published in 1987, although its roots go back to the MIL-Q-9858 United States Department of Defense standard that was published in 1959. ISO 9000 is based on the standards put forth by the British Standards Institution (BSI) that were presented to the ISO committee in 1979. MIL-Q-985 was revised into a NATO AQAP standard in 1969, which were then revised into the BS 5179 standard in 1974, which were once again revised to become the BS 5750 standard submitted to ISO to become ISO 9000.

The ISO 9000 series consists of the following standards: ISO 9000, ISO 9001, and ISO 9004. They are used when necessary with the ISO 10000 series of guidelines, as well as ISO 16949 and ISO 19011, specific guidelines for the automotive and environmental industries respectively. In its latest edition, ISO 9000 is ISO 9000:2005, and provides the fundamentals and establishes the vocabulary used in the remainder of the ISO 9000 series.

The main standard, ISO 9001:2008, lists the requirements for a QMS, and is the basis for all of the other ISO standards and guidelines in the 9000 and 10000 series. It is the only auditable standard in the series. ISO 9004:2000, the latest edition of that standard, provides guidelines for performance improvements in a wider spectrum than does ISO 9001 for sustained success in quality systems.

The ISO 9001:2008 standard consists of eight sections, with the last five being specific to the establishment of a quality management system that is sustainable and auditable. Specifically, they are:

• Chapter 4: Overview of Systemic Requirements – This is a general introduction to the requirements of Chapters 5 through 8, and establishes the baseline for developing a quality management system based on ISO 9000:2008. This section requires a business to develop and maintain a quality manual, control quality documents, and maintain all records related to quality. It states that your procedures manual and documents must reflect what the business is doing and the manner in which it is to be accomplished.
• Chapter 5: Overview of Management Requirements – This section defines the six sets of requirements that the management of a business must follow. It states that management must satisfy customers, support quality requirements, establish the policy for quality within an organization, perform periodic reviews, carry out the quality policy laid out, and control the quality system.
• Chapter 6: Overview of Resource Requirements – Chapter 6 requires the recognition and establishment of quality resources within the business, including personnel, work environments, and infrastructure. Personnel placed in quality roles must be competent. Work environments must be fit to ensure a quality product is built. Infrastructure to fit the needs of the quality program must exist and maintained.
• Chapter 7: Overview of Realization Requirements – This section of ISO 9001:2008 requires a business to recognize the processes that bring a product or service into being. A business must control customer processes, planning processes, and production processes. The quality aspects of the business’s product must be identified and controlled, and customer communication processes must be developed and controlled. Product design and development outputs must be controlled, and must be approved prior to implementation. These outputs must then be used to control product quality. Chapter 7 also establishes the need for validation, review, and design of a process, as well as the need to manage changes required of the product.
• Chapter 8: Overview of Remedial Requirements – This final section requires that a business execute remedial actions as necessary based on a plan devised and provided by the organization. This includes the measurement and monitoring of processes used to demonstrate conformance with the ISO standard, and improve the quality of the processes and product. Chapter 8 sets forth requirements for the control of non-conforming products, including records establishment and maintenance, controlling their use, and verifying that the non-conformances have been corrected. This chapter also lays out the requirements of a continuous quality improvement process to prevent future non-conformities from occurring.

Presently, there are over 350,000 companies in over 100 different countries that are certified in the ISO 9000 process.

Organizations who invest the time and effort to become certified under the ISO 9000 process demonstrate to the business community that they are committed to creating their product based on a set of internationally-accepted standards.

Certification involves creating a QMS based on the criteria set forth in ISO 9001:2008, and then agreeing to commit to audits, both internal and external to the organization, to ensure that they are maintaining those standards.

ISO 9000 certification helps a business not only helps the organization develop and maintain an actionable QMS, but can also help it market that quality commitment to other businesses and consumers to expand its presence in its market niche.

The post What is ISO 9000? appeared first on CEBOS Quality Management Software.

Original Equipment Manufacturers (OEMs) in the automotive industry raced to comply with QS-9000, which was based on the ISO 9000:1999 quality management system. ISO/TS 16949:1999, the quality standard for the automotive industry, wasn’t considered significantly different from QS-9000 and conversion was slow.  As the ISO 9000 quality standard was revised, changes were made to the ISO/TS 16949 standard.  The ISO/TS 16949:2002 version put a greater emphasis on customer requirements.  OEMs felt changes were significant enough to give automotive industry suppliers a deadline to comply with the standard or be removed from the supplier list. Ford, GM and Chrysler required suppliers to certify to the new ISO/TS 1949:2002 standard by December, 2006.

One of the criticisms of the QS-9000 standard was the complicated implementation process. The International Automotive Task Force designed the revised standard with an improved implementation process.  It took a page from quality system design by incorporating input from suppliers, manufacturers and industry experts.

More than Just Compliance to the Standards

The revised ISO/TS 16949:2002 standard put more emphasis on customer requirements.  The revised standards aimed to improve effectiveness and efficiency of the entire process instead of a narrow focus on mere compliance with standards.  A company cannot continue to compete effectively with a quality system that is costly and inefficient.   The revision required employee training and a process to measure the effectiveness of employee training as part of the quality system audits.

The ISO/TS 16949:2009 revision is based on ISO 9001:2008.  It keeps the customer focus of the ISO/TS 16949:2002 version and requires building quality into the entire supply chain process.  It has the dual goal of improving quality and reducing costs—two business elements that can satisfy customer requirements and the bottom line.

Top Down Approach

A quality management system cannot succeed without management support.  The revised ISO/TS 16949:2009 version makes productivity, cost effectiveness and customer satisfaction equal goals that promote growth and the ability to compete in a global market.  These goals are easy for management to support and promote within the organization.

ISO/TS 16949:2009 goes beyond managing the quality process by making it proactive.  Instead of detecting non-conformance, errors and waste just through the audit process, it seeks to build in quality processes at every stage of the supply chain to eliminate the root cause of defects and non-conformance.  While customer feedback is important to the process, it doesn’t wait for customer complaints to analyze, revise and improve processes.

Each revision of the ISO/TS 16949 quality system requirements made it more critical for automotive industry suppliers to move away from the old QS-9000 standards.  A supplier has to comply with the new standards to stay in the game and continue to do business in the industry.

As part of the automotive industry supply chain, it must have a compatible quality management system to provide quality materials or supplies required by the OEMs.   A company with QS-9000 certification may meet all internal quality standards but lack the new requirements emphasizing customer focus, efficiency and cost effectiveness.   A company without ISO/TS 16946 quality system certification will be left on the sidelines while other certified suppliers continue to play and win the game.

The post The Automotive Industry’s Shift from QS-9000 to ISO/TS 16949:2009 appeared first on CEBOS Quality Management Software.

Suppliers to the automotive industry are required to obtain PPAP approval any time they change or modify any component used in the production of a part, as well as any time the manufacturing process itself is changed.  To obtain approval for the change, the supplier must provide samples of the finished part and documents to prove that it understands the requirements of the client, can produce the product to meet the client’s requirements, can produce conforming parts, and that it has processes in place to handle non-conforming parts such that they will never reach the client or compromise the reliability or safety of the vehicles in which they are installed.  These requirements apply not only to the actual part, but also to any components supplied by subcontractors.

How the Software Can Help

The package created for PPAP submittal accompanying the Part Submission Warrant (PSW) can be very involved and elaborate depending on the extent of the changes or modifications required.  There are 17 elements that can accompany the PSW, most of which are in record form, and each of those records may have a series of documents contained within for support or clarification.  The control plan, the Process Failure Mode and Effect Analysis (PFMEA), and Records of Material/Performance Tests are all examples of portions of a complete PPAP submittal that can prove to be extensive.

A variety of pre-built software applications have been developed to aid the supplier in the submittal process for the PPAP package.  Some are simple and straightforward, containing only templates of the forms required, while others contain complete FMEA and CAD drawing packages and statistical process analysis to assist electronic submittal.   Many have preloaded document formats to allow for the creation of packages specific to customer requirements, integrated email capabilities to send reminders, and change logging to create a historical audit trail of changes made to product and process information.

PPAP software can save a supplier substantial amounts of money by removing the inefficiencies from the process, including the exorbitant amount of time needed to complete changes to the process flow, redundant data entry, record keeping, and manual approval workflows.  The software can also reduce the possibility of data entry or keystroke errors, mismatched FMEA, process flow, and control plans, and other common human errors that slow the approval process or result in audit findings and compliance risks.

The main benefit of PPAP software comes with continued use. 

Because of the library and historian features found in many of the software programs, changes can be made in one location, and all of the other affected documents will be automatically updated.  Data provided in one format can be transposed to other formats to fit specific applications such as the check sheet, router, control plan, and PFMEA.  Data stored from other PPAPs can be automatically linked to a new PPAP, reducing the time needed to generate the documentation.  Systems analysis and reporting can allow a supplier to create an effective continuous improvement process.  Compliance with other automotive quality specifications can be verified with the PPAP software, including ISO 9001, ISO 13485, ISO 22000, and TS 16949.

PPAP software can be used to help a supplier improve efficiency through document management and authoring tools within the software, increase customer satisfaction through improved supplier product reliability and quality, and meet all of the customer’s specific requirements and standards. It can reduce the demands placed on suppliers resources to develop unique PPAPs for each part for each customer, and can substantially reduce the time and costs associated with the generation of a PPAP package.

The post How Software Can Help in the Production Part Approval Process appeared first on CEBOS Quality Management Software.

Not surprisingly, the number of suppliers, distributors, and manufacturers of food products associated with these outbreaks has also increased, leading governments to increase oversight and regulation, costing companies and consumers billions of dollars in added expense.  Even with quality management systems such as the Safe Quality Food Program and standards to guide the industry, prevention must remain front and center when setting up the testing, inspection, and documentation systems required in order to avoid having tainted food reach the consumer.

The Public Demands Safe Food on its Table

Companies who violate that trust, even unwittingly, can find themselves with lost market share or the subject of negative publicity.  It can take years for a company can recover from the effects of one food-borne illness associated with its brand.  That’s why prevention, in the form of the strictest of quality control programs from raw material suppliers through delivery and distribution systems, must be the focus of every organization that supplies food to the public.

With increased reporting and investigation of food-related illnesses comes increased government intervention and regulation, which leads to even more outbreaks being detected.  The most recent of these new regulations, the Food Safety Modernization act of 2011 in the United States, is just the latest example of a government reacting to preventable outbreaks due to food contamination with a strong set of regulations. This act, overseen by the US Department of Agriculture, requires mandatory Hazard Analysis & Critical Control Point (HACCP) documentation for every variety of seafood, meat, poultry, juice, and dairy product under its jurisdiction.

Not only does this increase the operating costs and insurance rates for businesses in the food industry, but it may have the added effect of changing the specifications for food products, altering and adding to the auditing processes already in place.

The Food Industry Gets Together

The Global Food Safety Initiative (GFSI) was created in 2000 to deal with the increasing issues surrounding food safety.  GFSI is a world-wide consortium of retailers, suppliers, and food manufacturers that benchmarks food safety standards, and has set out standards and best practices within the industry that are almost universally accepted.  One of the mainstays of the GFSI is the Safe Quality Foods (SQF) program, a food safety certification program with three levels of qualification, each with increasing rigor regarding the analysis, management, testing, and documentation of food quality and safety.

SQF Level 2 is a risk analysis and hazards management plan using the HACCP approach, while Level 3 adds food quality to the safety aspects managed in Level 2 programs.  Both levels 2 and 3 are recognized by GFSI to achieve registration.

A similar food safety and quality program has been developed by the International Organization for Standardization (ISO) as ISO 22000.  Developed to work in conjunction with an existing ISO 9001 quality management system program, ISO 22000 is a Food Safety Management System Certification process that is also based on HACCP analysis.  The ISO standard is a little less regimented than the SQF program in that there is no specific set of prerequisite programs required for ISO like there is for SQF, which allows each supplier and producer some flexibility in how the program is implemented.  The ISO 22000 program is not recognized by GFSI, but a similar program, FSSC 22000, is.

In either case, whether a food industry producer or supplier chooses to develop and adhere to the standards laid out by the SQF program or ISO 22000, the focus of the program must be prevention if it is to avoid the negative aspects associated with a food-borne illness and its brand.

That means exacting standards, inspections, testing, and documentation must be in place for all raw materials suppliers, packagers, handlers, employees, transportation, warehousing and distribution, and point-of-sale retailers that contact the product in any way.  A business should insist that all of these groups adhere to the standards set forth by GFSI, and have programs in place where applicable that have been certified by a third-party auditor.

Having strict quality management systems in place like these gives a business its best chance of stopping an outbreak of illness related to contamination of its products before it begins.

The post The Importance of Prevention in Safe Quality Food Programs appeared first on CEBOS Quality Management Software.

TQM capitalizes on the involvement of management, workforce, suppliers, and even customers, in order to meet or exceed customer expectations through your quality management system. By reviewing the fourteen points made famous by Deming, it’s easy to see what total quality management entails:

1. Create constancy of purpose for improving products and services.
2. Adopt the new philosophy.
3. Cease dependence on inspection to achieve quality.
4. End the practice of awarding business on price alone; instead, minimize total cost by working with a single supplier.
5. Improve constantly and forever every process for planning, production and service.
6. Institute training on the job.
7. Adopt and institute leadership.
8. Drive out fear.
9. Break down barriers between staff areas.
10. Eliminate slogans, exhortations and targets for the workforce.
11. Eliminate numerical quotas for the workforce and numerical goals for management.
12. Remove barriers that rob people of pride of workmanship, and eliminate the annual rating or merit system.
13. Institute a vigorous program of education and self-improvement for everyone.
14. Put everybody in the company to work accomplishing the transformation.

Using these principles as a standard of measurement against your existing processes within the business can help you then build quality management into your work systems as well.

The areas to focus on when building TQM practices into your existing systems can be broken out as follows:

• Customer Focus – Make sure all of your methodologies, changes, and improvements are focused on enhancing the customer experience. If the customer does not benefit in some way from a change you’re about to make or a process you’re considering improving, don’t do it. If it adds no value to the customer, it adds no value to the business.
• Tools and Methodology – Develop and implement tools within your business that enable employees to quickly find and isolate non-conforming materials. Ensure that there are procedures in place to find and fix the source of the defects permanently to remove future failures from the process.
• Continuous Improvement – Quality procedures and manufacturing processes should undergo a process of continuous review and improvement. This could be measured by the number of defective products made, the number of products made within a percentage of the control limits, or some other similar metric based on your company’s standard. Before this can begin, however, a benchmark must be established against which future improvement is measured, with the mark continuing to increase as quality is improved.
• Employee Involvement – Your company must empower employees to find and correct quality issues as they arise on the production floor or in the test lab. This should be a formalized system to provide feedback to the employee once changes are made. Any employee in your organization should have the ability to address immediate issues as they arise without fear of reprimand or backlash.
• Company Culture – You must establish a culture within your company that improves the ability of employees work together to solve quality issues. This can be in the form of regular team meetings to seek input, formation of a quality improvement oversight committee or task group, or having a quality leader identified within each group of your organization to get and share quality-related issues with others.
• Executive Management – Top management owns the total quality management process. You must believe in it, and make sure all of those around you believe in it as well. Quality is driven from the top down, and if employees see that their management is not committed to quality, they will not commit to it either. The environment within your company should breathe quality to ensure success.
• Training – Your employees should constantly receive training as it relates to quality. This also includes refresher training on job-related tasks and procedures, as they tie directly back into quality production as well.
• Decision Making – To thrive in a quality environment, decisions about quality should be made based only on measurements. There should be no gray areas existing within the company. If it is within the written specifications, it is acceptable, if it is outside of the specifications, no matter how slight, it is non-conforming. Only when quality is handled in this way can the continuous improvement process work and be effective as you tighten your control limits.

The post Building Quality Management into Your Systems appeared first on CEBOS Quality Management Software.

HACCP Provides a Systematic Approach to Food Safety

In the past, food safety was relegated to single point inspections and spot checks.  Now the focus is on establishing a food safety system.  Inspectors from federal and state agencies, as well as key customers, are as concerned with auditing the food safety system as they are in spot checks of work areas or activities.  This is because a functional food safety system built on HACCP principles will identify and correct potential hazards or the need for better control without waiting for outside inspectors to discover the problem.

While HACCP is not a regulation or standard itself, it lays out the principles for creating a food hazard prevention system that serves as the foundation for meeting food safety regulations internationally.  Plus, it also is highly suitable for incorporation with other Quality Management Systems like the ISO 9001 and ISO 22000 standards.  It directly aligns with ISO fundamentals like; create a plan, define and monitor processes, and take corrective action.

The Seven HACCP Principles

HACCP is built on seven principles to establish an on-going food safety system.

1. Conduct a Hazard Analysis:  For every process/product, determine the risks and sources for potential hazards.  This could include unsafe temperatures, exposure to contamination, and time delays.
2. Determine Critical Control Points (CCPs):  After potential hazards are identified, determine where and how each hazard could be introduced (i.e. exceeded acceptable temperature while stored in receiving area). These are areas that require adequate controls to prevent the introduction of possible hazards.
3. Establish CCP Limits:  Determine the acceptable limits or ranges to prevent safety issues (i.e. safe temperature range or shelf life).  A control point limit could also address potential contamination, and call for regular cleaning of work areas and equipment, periodic training, or air quality standards.
4. Monitor CCPs:  Once critical limits are established, control and monitoring have to be set in place to ensure the limits are not exceeded.
5. Establish Corrective Action:  A plan should be in place to take corrective action anytime a CCP limit is exceeded or not met.  In order to maximize consistency and minimize risk, the plan should call for a specific action to address a specific CCP violation.
6. Establish Record Keeping:  A proper food safety system will generate evidence of compliance in the form of records that show CCPs are not exceeded and mitigation activities are carried out.
7. Verify the Functionality of the Food Safety System:  The last HACCP principle requires that procedures are established to verify the system is effective at controlling safety hazards and adaptable to meet changing requirement and improve over time.

These principles have proven effective for any size of organization anywhere in the food supply chain – from farmers to retailers.

Using HACCP Software for System Management

There are numerous software packages available that claim to assist organizations with implementing and managing HACCP principles.  Many of them will simplify aspects of record control and document management.  They are certainly worth exploring, and perhaps there is a great match between a HACCP software application and a particular organization’s HACCP goals and needs.

Comments posted on food safety related bulletin boards, however, suggest that some organizations experimenting with HACCP software eventually return to the basics; using Word and Excel to document and manage HACCP.  They like the flexibility and familiarity of the MS Office applications, in opposition to the learning curve and the difficulty in customizing off-the-shelf HACCP software. The same comments are common for other types of Quality Management System software, as well.

Whether you use Office apps or a HACCP software program, implementing the HACCP Principles provide the logical, scientific, and systematic approach needed to deliver food safely to consumers.  HACCP is an internationally recognized way for a business in the food industry to realize its ultimate goal; a safe product.

The post Food Hazard Analysis and HACCP Software appeared first on CEBOS Quality Management Software.

Use TQM to Improve Customer Satisfaction

A primary focus of TQM and most Quality Management Systems is to improve customer satisfaction by having a customer focus and consistently meeting customer expectations.  Customers are almost always satisfied when their expectations are met. When they expect a certain product or service, and you delivere it without problems and at a fair price, you’ve built a solid customer relationship.  Happy, satisfied customers become repeat customers and they provide word-of-mouth marketing – the most powerful kind. 

There are three Total Quality Management components that work toward achieving customer satisfaction:

1. it requires that your business understand what customers typically expect in a field, industry, or product line,
2. it ensures your business has the expertise and the resources to consistently deliver the expected product or service, and 
3. it emphasizes the need for your business to clearly communicate to the customers exactly what you will deliver to avoid misunderstandings. 

TQM provides the quality assurance that customers will get what they expect, as well as a process for managing unsatisfied customers, make needed corrections and prevent similar reoccurrences.

Every business owner and manager knows the importance of satisfied customers, and how expensive it is to find new customers compared to keeping current customers.  Business research clearly shows that there is a direct correlation between satisfied customers and revenue.  If your business doesn’t have a clear path to creating satisfied customers, then it can benefit from TQM.

TQM Improves Business Efficiency and Effectiveness

While focusing on the customer is critical to success, it isn’t the only factor.  A business can go broke sparing no expense to make customers happy.  So not only does a business need to satisfy customers, but it needs to do it in a way that is.  A business also has to look within and understand its own operations, another important role of a quality management system.

Total Quality Management places a focus on internal processes, including

• How processes align to produce desired outcomes to satisfy customers
• How consistently processes deliver desired outcomes (effectiveness)
• The productivity of a process compared the resources used (efficiency)

Being able to consistently produce desired outcomes without wasting resources like time, material, and money is critical for a business to make it over the long haul.

TQM Provides Long Term Competitiveness

Being able to satisfy customers while operating effectively and efficiency is truly the recipe for financial success and stability. If you achieve these quality assurance goals that are part of Total Quality Management, then you will likely be in business for a long time to come.

Notice that with TQM, quality is not just about a product or service meeting (somewhat arbitrary) requirements.  It is about how the whole organization operates to understand customer expectations and competitively deliver customer satisfaction.  

No Easy Task

It is important to remember, however, that TQM takes full commitment from management.  Simply tossing the concept down to employees and saying “do this” just adds an extra burden on workers without much benefit from their efforts.  Organizational members take their cue about what is important from management.

Only through top management commitment and involvement does TQM take hold and become part of the organization’s culture.  Once ingrained as the way of doing things, the business can reap the benefits of TQM – including a healthier bottom line.

The post How Can TQM Make Your Business More Successful? appeared first on CEBOS Quality Management Software.