With over twenty five years in the testing business and a total of thirty years in the industrial services sector, I champion the importance of a balanced approach in prioritizing the development and delivery of new products and services to the market. The ultimate conclusion of the development life cycle for the team of testers is to deliver to the end user products and services with a safe, quality and cost driven value proposition.
My experience has often centered on power generation, commercial nuclear power and heavy industrial services for OEMs and manufacturers. In this era of global competition and accelerating life cycles, the need to get new products to market faster is more compelling than ever. Over time, I have come to appreciate the drive of the engineers, the innovators and the manufacturers who bring forth new products to meet a variety of market needs. Many of these needs can be customer driven for cost and comfort, regulatory driven for efficiency and environmental value or corporately driven to stimulate productivity and profit.
When product initiatives commence, they progress through the typical product development stages starting with conceptual/ prototype design and culminating with the product launch into the market. A vital juncture of the new product development is the validation, certification and testing phase of the product or component. Most of the tasks assigned at this juncture call for a partnership between product engineers and testing specialists with collaboration from the product development team who are making decisions based on market data. This model has been a tried and true template for many successful product launches over the years as implemented by many medium size and large Original Equipment Manufacturers (OEM)’s.
A critical factor in this process, which must be taken into account, is the intangible element of the product validation or testing process. This includes the unseen touchstones of the equipment qualification process: Quality, Safety and Security. During the initiation of new product development, starting with the project management phase, it is beneficial for the manufacturing team to integrate these intrinsic, preventative safeguards into the new product development model. A successful launch is more likely with early review of these three measures.
Quality requires a fundamental discipline to adopt all requisite industry specifications and customer driven requirements into the program and impose them on all subcontractors. In many cases, these include written standards that provide the guidelines for Equipment Qualification (EQ) programs. Standards are typically driven by the industry and can include such requirements as MIL, IEC, IEEE, ASTM or ASME to name a few. The industry standards will often be the overarching document that drives the product qualification plan, and ultimately, the test plan. Customers and/or end user review and acceptance of the test plan and procedures may be required. It is often mandatory and invariably critical to get “buy in” or verification of either a third party standard or customer acceptance when implementing a product validation program.
The other consequential component of the Quality Plan is built on the Quality Program of the subcontractors who support the product validation/certification program. The ultimate acceptance and justification of the product validation process is incumbent on the Quality Certifications of the sub supplier or test facility. It is generally required and always advisable to establish that the laboratory or validation service company has the proper credentials and certifications. There are several layers to verify the credentials of the subcontractor including a copy of their Quality Certificate or an actual physical audit of their Quality Program. In the Test, Inspection and Certification (TIC) Service Industry, most qualified laboratories operate to ISO 17025 Quality Guidelines. Quality programs are audited and qualified by independent certification agencies such as: A2LA, ANAB, NAVLAB, Perry Johnston as well as others. Many TIC Service Companies will have supplemental QA/QC programs such 10 CFR Appendix B, AIHA. The layers of quality programs with their imposed requirements may sometimes affect the price of the certification services. Regardless, it is advisable to link the quality assurance process with a qualified laboratory that implements the requisite standards during product validation. This will provide certainty to management and peace of mind to the development team that all measures have been taken to prevent problematic or disastrous issues during the new products life cycle.
Safety is a crucial and fundamental pillar of product development and manufacturing. Product safety must always be wholly integrated as a key element of new product development. Consideration of functional safety is typically a provision of design that is engineered into products at early stages. However, many tangential aspects including system integration and unknown or changing environmental conditions are routinely assimilated into product design and the validation process. During assimilation, a design revision or the evolution of an existing product, product safety could be inadvertently neglected.
Another significant consideration covered by the broad scope of safety during product development is safety during the certification process. Production safety is generally covered during the manufacturing process and is guided under the auspices of the manufacturing plant’s safety program. Under US guidelines, these are driven by OSHA regulations, (The Occupational Safety and Health Act of 1970). It is essential that subcontractors and certification service providers have a valid safety program and are fully compliant with all OSHA standards. The implementation and observation of industry safety practices are imperative for countless reasons. A disciplined, robust safety program ensures the personal safety and security of the experts and skilled workers conducting the certification program. A lapse in safety could result in physical harm and, under extreme circumstance, a catastrophic event. Furthermore, a safety breach could have a harmful effect on the product development program. Extensive program delays and potential stigmas could result from an unforeseen accident related to the certification program. Safety is an individual, group, team and corporate responsibility. Everyone throughout the entire organization must take ownership of a positive safety culture. It is a multidimensional grid of responsibility that is a 360* radius of people policing on an endless term 24/7/365.
The final intangible aspect of responsibility encompassing the product development team is Security. In today’s global environment that consists of an internationally diversified supply chain, intellectual property (IP) and proprietary information is constantly at risk. Capital investment in product development and the underlying proprietary products (IP assets) are the life blood of a manufacturing company. Loss of exclusivity of a product can erode market share and have a material impact on the value of a company not only from a competitive posture but also on the balance sheet.
During the certification process, both the OEM manufacturer and subcontractor must take all reasonable measures to ensure confidentiality and security of the product or component. Before details, test plans, specifications and drawings are shared a Non-Disclosure and Confidentiality Agreement should be executed by both parties. This is usually a standard agreement that provides mutual covenant protection for the manufacturer’s proprietary information. Once this document is signed by both parties, it will be filed with all documents associated with the product validation and test program.
To ensure confidential and secure validation test programs, it is advisable to assess the subcontractor’s security policy. This should be a standard, written policy with a manual similar to the QA Manual and Safety Manual. All employees of the subcontract laboratory should be thoroughly familiar with all laboratory policies and have received periodic training in the requirements and implementation of the Security Program.
In some circumstances, product certification test laboratories implement formalized security programs that qualify services to military and defense contractors. These programs will meet the precise requirements that adhere to the sensitivity of the program. Levels of government security can include: NOFORN, ITAR or Classified. Company security programs are typically self-certified and will be audited or scrutinized by a contractor or government agency overseeing the certification. Basic requirements of security programs go beyond confidential or classified government programs. Making sure manufacturers products and documentation are secure and not open to public exposure should be a minimum standard for all companies in the TIC industry.
These three dynamic ingredients of product validation services should be guided by written procedures. The programs and the written documents are the foundation of accountability. The culture, implementation and execution by the entire company will provide the structure upon which success is built. Manuals can be window dressing and training can be an exercise in futility. The daily practices and protections that are vigorously supported by top down management will insure that these “Non-Mechanical Aspects of Mechanical Testing” are as indispensable as the engineering and technical advances of product development.
Paul G. Heffernan
CEO