What is Compliance Engineering?

Product compliance regulations approvals laws requirements
Product compliance regulations approvals laws requirements

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. And intended the environment and specific mandatory requirements. A compliant product usually has to undergo evaluation through 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 a well-founded method to efficiently achieve compliance during the final evaluation process. EMC Bayswater conducts EMC pre-compliance testing to investigate EMC issues. This helps mitigate EMC failures during the final compliance process using good engineering practices and knowledge of practical EMC and EMI solutions.

Considering Compliance Engineering a product!

At 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, 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 labelling, compliance documentation and end-user information. There may also be market surveillance or customer feedback that may need 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 the protection of the operator typically much more rigorous testing

Protection of Environment

Electromagnetic interference (EMC & EMI)

Product Installation

Facility requirements

Operation of Product

The user interface (ease of use, interpretation of displays, the effectiveness of interface)
Alarm features (intensity, frequency content)
Instruction manual

Product Maintenance

Maintenance personnel
Training requirements

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
The 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 the 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. Usually requiring 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

Is compliance required?

It is miss-understood that the sole responsibility lies with the manufacturer. The manufacturer is responsible for producing a compliant product. Through the development and compliance engineering the product to meet the required compliance specifications. The supplier to the market either the manufacturer or an independent importer should engage in inspection or testing activities.

Who can do compliance testing?

This can be achieved through either internal or external inspections. Or through independent inspection and testing laboratories. The choice of such an engineering testing service should be made. And based on their ability to perform the product evaluation. This sometimes can be confusing as many laboratories will offer these services. Accredited inspection and testing laboratories or suppliers have met the required standard. And can show competency in performing the process. These specialised testing service suppliers usually perform that service on a daily basis. And can usually offer guidance and help if compliance engineering is required. Usually, these laboratories will stand behind their results. And will be able to prove verification of processes, equipment suitability and calibration.

Does every sample need to comply?

The manufacturer must maintain manufacturing consistency. Ensuring 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. Then it may require batch testing or random sampling of products. Periodic inspection is to ensure the build components have not altered to the original tested sample. Production changes may cause non-compliance with a product. 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 on the EMC compliance of the product.

During the product lifetime, manufacturers may need to alter the components. An example would be a component that is no longer manufactured and a substitute part installed. Sometimes full compliance testing is a must. Other times only partial testing. A risk assessment and impact must be evaluated. Along with good engineering, practice to determine which route to put in place.

Compliance enforcement

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. Besides, they can also investigate any feedback from the public regarding a product’s compliance if brought into doubt. This may lead to the re-testing of the product. Usually at an accredited facility. With large financial fines and with-drawl/re-calls of the product.

End user’s compliance requirements

Finally, the end-user is also responsible for the 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. Modification of the product usually invalidates any product compliance. And possible voids any responsibility of the manufacturer.

Related Posts

RCM approval for cellular devices

RCM approval for cellular devices

The Australian Communications & Media Authority (ACMA) require any  device that connects to a mobile phone network (2G, 3G, 4G or 5G etc.) must comply with the applicable mandatory standards as referenced within the ACMA Telecommunications (Labelling Notice for...

read more
Why compliance testing is actually good

Why compliance testing is actually good

One purpose of product compliance testing is to ensure that a product or device meets the regional compliance requirements, these requirements are usually mandated by law). Regions are usually regulated by assigned organisations such as government bodies, examples...

read more
A guide to CE Declaration of conformity (DoC)

A guide to CE Declaration of conformity (DoC)

CE marking affects the supply of products and allows free movement and sale of goods throughout the European Economic Area. CE-marking is mandatory within this region and as part of the mandated requirements, it requires documentation in the form of a ‘Declaration of...

read more