Understanding Regulatory Compliance

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Understanding

Regulatory

Compliance


Understanding Regulatory

Compliance

There has been a rapid boost in the new global

product-related regulations/standards

development activities. As a consequence,

organizations are trapped in the complex

loop of various local, national and worldwide

product targeted regulations.

A simple reporting error, lack of proper registration

and compliance can result in significant fines

and penalties, ban on selling products/product

recall, customer and supplier loss and severe

damage to the corporate image.


Current Scenario

Governments, suppliers and consumers are emphasizing the determination of

chronic health and environmental hazards associated with the life cycle of

materials and products

Many manufacturers willingly take back or buy back their products from end

users at the end of product life cycle for proper recycling and waste

management.

Many product based companies are currently focusing on the production of

safer and biodegradable materials.

EPR “Extended Producer Responsibility” as an environmental policy approach in which

a producer’s responsibility for a product is extended to the post-consumer stage of a

product’s life cycle”


Regulations & Standards

Registration, Evaluation,

Authorization and

Restriction of Chemical

Substances (REACH)

Restriction of

Hazardous

Substances (RoHS)

Waste Electrical and

Electronic Equipment

(WEEE) directive

Toxic Substances

Control Act (TSCA)

The important characteristic of these regulations is that they transfer the risk

management responsibility over to the producers and importers of the products


Challenges in Product Compliance

Inability in obtaining

correct and timely data from various sources

Lack of knowledge

among suppliers regarding regulatory

requirements

Gaps in recognizing and evaluating risks associated with non-compliance

Lack of reliable, transparent and

auditable business

processes

Lack of resources to

facilitate process

compliance assurance

Inefficient & inappropriate

data collection and reporting

methods


Crucial Steps

Identify and map the

processes to

specific regulation in

a compliance matrix

Understand the

relevant product-

targeted regulations

Conduct a

methodical gap

analysis

Ensure risk

assessment of all

products

Develop an efficient

data management

system

Supply chain

collaboration is

important

Implement non-

biological

procedures

Confirm safe and

compliant handling,

storage and

transport

Adopt “green

chemistry” and make

products

“sustainable”


The Ultimate Apprise

Implement automated systems that can help in managing regulatory compliance by

analyzing regulatory changes, material data, suppliers, or BOM change, and quantity

and movement tracking

The best advice is “be prepared” and “comply fully as soon as possible” because non-

compliance may have severe effects on your business and corporate image


For more details please visit the link below:

http://www.wipro.com/Documents/understanding_regulator

y_compliance.pdf

http://www.wipro.com/Documents/understanding_regulatory_compliance.pdf

http://www.wipro.com/Documents/understanding_regulatory_compliance.pdf


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customers. It specifically surveys innovative strategies that will help

customers gain competitive advantage in the market. The Council, in

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studies market trends to help equip organizations with insights to

facilitate their IT and business strategies.

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www.wipro.com/insights or mail [email protected]

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