7 Signs Your Quality Management Program is in Trouble
Product quality problems don’t happen overnight, nor are they the result of a crippled procedure or one poorly conceived policy. The problems have brewed over time, sending out signals that risks to product quality are growing.
A breakdown of quality is not an event. It is a process. Long before a quality failure explodes on the front page of The New York Times, a company’s quality system has been in trouble because of corporate decisions, policies and programs.
Warning 1: Misaligned Messages
The external quality message doesn’t match internal practices
If a company gives mouth service to its commitment to quality, but 
relegates it to a periphery, “fringe function”, not an essential, high-level company priority, then morale and quality are sure to suffer.
Companies must give more than lip service to the quality function, both in term of human resources and quality management systems. Otherwise they should be prepared to pay the many costs and woes associated with fluctuating or low quality.
Warning 2: Ineffective Processes
Ineffective or non-existent process for determining employee qualifications
Not only do you need quality management professionals who have the requisite background needed for their positions, but you need a formal, documented process for ongoing employee training. Employee training and qualification software that incorporates reminders and documents completion of on the job training can make the burden of ensuring that all employees are trained on the latest procedures and work instructions a seamless part of a quality management system.
Warning 3: Siloed Compliance
Compartmentalized leaders impact quality
Whether by design (organized subsidiaries, operating companies or divisions – or through tradition (often a strict, hierarchical organizational structure), many companies have created siloed organizations that inhibit communication, collaboration and consistent practices across the enterprise, particularly in the areas of quality and compliance. It’s this siloed mentality that prevents companies from identifying enterprise-wide problems through accurate root cause analysis and transparency among facility managers and leaders.
Warning 4: Budget Cuts
Maintenance and housekeeping budgets are cut
Harsh economic times has intensified the urgency for companies to identify potential cost cutting opportunities. Often, maintaining equipment and facilities is seen as ‘low-hanging fruit” that can be reduced without undue risk to operations.
Savvy professionals take a strategic, company-wide approach to enterprise risk management, minimizing all risks that can significantly undermine business value. By performing enterprise risk management (ERM), companies protect the safety of all their resources, including governance, business processes, operations, and network infrastructure.
Warning 5: Training Overload
Training overload can create quality risks
A worker in today’s sophisticated manufacturing facilities may be responsible for understanding hundreds of Standard Operating Procedures. The SOPs may be revised several times a year, and each revision requires new training to ensure compliance.
Recently, the U.S. federal government has become focused on ensuring that training is provided in the language understood by learners, increasing the importance of providing training in multiple languages. That requirement exists for facilities inside the U.S. with multi-cultural workforces and for foreign facilities operated or contracted by U.S.-based companies.
Ensuring that your quality management system and employee training and quality control software supports multiple languages in today’s global economy provides your company with a competitive advantage. Quality products are the result of quality-conscious actions by individuals throughout the production process, regardless of location.
Warning 6: Poor Records
Records are unmanageable, inaccessible or out of date
Despite their central role in business management, 
critical records are often trapped in a netherworld of inefficient processes and conflicting technologies, forcing quality managers to grab vital information “on the fly”.
An effective document management system that meets compliance and serves as an essential operational tool for managers requires both financial and human investments. Today’s tough economic climate is often cited as the rational for postponing this investment, but it is a flawed rationale likely to produce serious management failings.
Warning 7: Supplier Disconnect
Systems with third parties are not harmonized
In today’s competitive marketplace, outsourcing has become an effective way to keep pace with rapidly advancing technologies and increasing pressure to trim time-to-market. But it also presents significant regulatory challenges, as original equipment manufacturers (OEMs) must monitor and control supplier performance in order to maintain compliance and ensure product quality.
Companies with supplier management software as part of their quality management system may use the system to create supplier quality policies even before they choose a supplier, helping them narrow the selection criteria. The supplier management software enables regular supplier assessments and monitoring, so that OEMs can identify problems before they become nonconformances.
(Source: Ellen Leinfuss, Kaplan EduNeering Life Science White Paper)
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