Compliance Engineering is designing and developing products to meet the applicable market compliance requirements including any rules and regulations (laws) formulated for that product. Compliance requirements may include safety testing, EMC Testing, Radio or wireless Testing, Protocol, human exposure to RF, IP Testing, material testing, shock and vibration testing, Human exposure and many more. The compliance requirements are dependent upon the intended use of the product the environment and specific mandatory requirements. A compliant product usually has to undergo evaluation though technical review or testing. This is to ensure it meets the stipulated compliance requirements. Compliance is usually undertaken by either the manufacturer or the importer of a product i.e. the responsible party.
Why is Compliance Engineering Important?
Firstly for each intended market, the product must meet the required compliance requirements such as Product safety compliance and electromagnetic compatibility (EMC). Thus designing the product from a compliance aspect at the early stage and through the development process is now a well-founded method to efficiently achieve compliance during the final evaluation process. EMC Bayswater conduct EMC pre-compliance testing to investigate EMC issues and help mitigate EMC failures through good engineering practices and knowledge of practical EMC and EMI solutions.
Considering Compliance Engineering a product!
The early stage of product development the intended regions or specific countries should be determined. Determine what compliance marks and compliance requirements are required for each. Compliance engineering including safety aspects such as component ratings etc should be continually reviewed throughout the product development. Some type of EMC compliance engineering is commonly required to achieve compliance at some stage during EMC testing. EMC Bayswater has many years of experience in EMC modifications and fixes.
Compliance requirements continue through the manufacturing and product placement stages, including labeling, compliance documentation and end-user information. There may also be market surveillance or customer feedback that may require further compliance checks.
Once the product is removed from service and the product reaches its end of life the compliance process is completed.
Components of Product compliance
Protection of Operator
Electrical shock hazards (hazardous voltages and currents)
Mechanical hazards (moving parts, pinch and impact)
Thermal hazards (fire and hot surfaces)
Radiation hazards (optical, ionizing, acoustic and EMC)
Protection of Patient
Similar to protection of operator typically much more rigorous testing
Protection of Environment
Electromagnetic interference (EMC & EMI)
Operation of Product
User interface (ease of use, interpretation of displays, effectiveness of interface)
Alarm features (intensity, frequency content)
Special precautions and circumstances
Unique to product
Achieving Product Compliance
Designing compliance with safety
Inherent product design is the primary approach to safety
Prescriptive safety requirements specified in the relevant applicable standards
Use of listed products within the scope of their intended use such as prescribed items
Design must always consider maintaining safety under normal (NC) and single-fault conditions (SFC)
Designing compliance with EMC
Identify potential EMI sources
Ensure correct grounding arrangements
Use effective filtering
Correct application and usage for the PCB and ensuring correct component layout
Pay special attention to the power supply circuitry
For further information refer to our EMC compliance consultancy page.
So you have successfully compliance engineered your product through testing and inspection. What else needs to be considered?
Product Labeling and documentation
Applying the appropriate markings on the product and/or the packaging as required. These requirements vary for each market and also usually require a statement of some description to be included regarding the compliance. Most products and markets including CE marking require a product risk assessment along with the Declaration of Conformity, product instructions and other accompanying documents.
Responsibilities of product Compliance
It is miss-understood that the sole responsibility lies with the manufacturer. The manufacturer is responsible for producing a compliant product through development and compliance engineering the product to meet the required compliance specifications. The supplier to the market is it either the manufacturer or an independent importer must engage in inspection or testing activities. This can be achieved through either internal or external independent inspection and testing laboratories. The choice of such an engineering testing service should be based upon their ability to perform the product evaluation satisfactorily. This sometimes can be confusing as many laboratories will offer these services. Accredited inspection and testing laboratories or suppliers have met the required standard to demonstrate competency in performing the process. These specialised testing service suppliers usually perform that particular specific testing on a daily basis and can usually offer guidance and assistance if compliance engineering is required. Usually, these laboratories will stand behind their results and will be able to demonstrate verification of processes and equipment suitability and calibration. The manufacturer must maintain manufacturing consistency to ensure the product tested is of the same construction and operating state as those produced for sale or distribution. If manufacturing is outsourced or not under strict control it may be required to involve batch testing or random sampling of products. Periodic inspection is to ensure the build components have not been altered to the original tested sample. Production changes may cause non-compliance of a product and this has been noted by EMC Bayswater, in several instances only due to a minor change which seemed to be insignificant but had a dramatic effect upon the EMC compliance of the product. During the product, lifetime manufacturers may need to alter the components etc i.e. a component is no longer manufactured and an equivalent part is required. Sometimes a full test is required other times only partial testing. A risk assessment and impact shall be evaluated along with good engineering practice to determine which route should be taken. Enforcement of product compliance is usually instructed by the designated authority for the market region. These authorities have the power to request evidence of compliance. In addition, they can also investigate any feedback from the public regarding a product’s compliance if brought into doubt. This may lead to re-testing of the product (usually at an accredited facility), large financial fines and with-drawl/re-calls of the product. Finally, the end user is also responsible for compliance. If they incorrectly use the product as per the provided documentation or don’t follow specific instructions to achieve compliance they may be responsible if any adverse effects are noted. In addition, modify the product usually invalidates any product compliance and possible voids any responsibility of the manufacturer.