OVERVIEW FOR MS 2626: 2016

CONSUMER PRODUCT SAFETY

AND RECALL – GUIDANCE IN
THE SUPPLY CHAIN

FROM: NUR ASYIKIN AMINUDDIN

MALAYSIAN ASSOCIATION OF STANDARDS USERS
MS 2626 CONSUMER PRODUCT SAFETY AND RECALL
– GUIDANCE IN THE SUPPLY CHAIN
- Combination of ISO 10393 (Consumer Product Recall) and ISO
10377 (Consumer Product Safety)
- This Malaysian Standard provides practical guidance for enterprises
of all sizes to assist them in assessing and managing the safety of the
consumer products they supply, as well as to the suppliers that do not
design or produce products, but are still responsible for their safety in
many jurisdictions.
The overall objective:
1) Reduce the product safety risks to consumers and users;
2) Reduce the risks to suppliers of product recalls;
3) Provide consumers and users with the information they need to
make informed choices with respect to the safe use and
disposal of consumer products; and
4) Assist governments by improving the safety of consumer
products.
 SCOPE
The standards covers elements of systems approach towards managing
production of safer consumer products from inception till the disposal of
a product in the supply chain. This standards helps the organization to:
 Identify, assess, reduce or eliminate hazards
 Manage risks by reducing them to a tolerable levels and
 Provide consumers with hazard warnings or instructions essential to
the safe use or disposal of consumer products
This Malaysian Standards applied to general consumer products
(regulated and unregulated) BUT exclude for FOOD, MEDICINAL
PRODUCTS, COSMETICS, and MEDICAL DEVICES.
 DEFINITIONS
 CONSUMER PRODUCT: Product designed
and produced primarily for, but not limited
to, personal use, including its components,
parts, accessories, instructions, and
packaging.
 PRODUCT RECALL: Corrective action taken
post production to address consumer
health or safety issues associated with a
product.
 SAFETY: Freedom from unacceptable risk
 SUPPLY CHAIN: Network that designs,
manufacturers, imports, distributes, and
sells a product
 VULNERABLE CONSUMER: Consumer
who could be at greater risk of harm from
products due to their age, level of literacy,
physical condition or limitations, or
inability to access product safety
information
BASIC PRINCIPLES OF PRODUCT SAFETY MANAGEMENT
IN THE SUPPLY CHAIN

 Stakeholder engagement
 Quality culture along the supply chain
 Precautionary principles
 Traceability
 Continual improvement
 Design
RISK MANAGEMENT

 RISK EVALUATION
i. Hazard identification
ii. Exposure analysis
iii. Consideration of use conditions
iv. Description of potential injury scenarios
v. Evaluation of the severity
vi. Evaluation of the probability
vii. Risk assessment

1. Description of products and its
hazards – Product size, shape,
biological, chemical, physical,
electrical, radiation, explosion
2. Condition of use
- home/office, 3. Identification of consumers and users
indoor/outdoor, - Type of consumer, intended user/unintended
fixed/moveable, climate user, foreseeable user misuse, hazard recognition,
condition, vibration, sunlight, protective behavior, behavior in incident
dust

4. Describe injury scenario in several steps

5. Determine the severity of injury 6. Determine the probability of exposure

- laceration, cut, bruising, concussion, - exposure, accessibility to hazard, duration,
entrapment/crushing, fracture, amputation, death frequency, probability

Redesigning or
7. Risk level provide the
protection
against the
8. Highest risk identified. Is it tolerable? hazards

No – Redesigning safe design measure or provide

Yes – Pass on risk assessment prediction against hazards (back to no.3)
 RISK REDUCTION

Examining the results of risk assessment

Evaluating the extent to which the reduction available will

reduce the risk and redesign the products

Incorporating protective measures into the product at the design

stage

Providing users with safe use information and warnings through

the provision of instructions for use, assembly, maintenance, and
labels

Acceptable Risk NO
YES
End
DOCUMENTING THE DESIGN SPECIFICATION PROCESS
 Records arising from the implementation of this standard
 Documents created during the design stage
 Risk assessment including data and information used
 Significant design choices and safety decisions
 Drawings, specifications and bill of materials
 Product quality and safety tests and approved product samples
 Validation of the design
 Validation of warnings and instructions
 Design testing and inspection
 Technical feasibility
 Compliance with regulatory requirements and product specific industry standards
 Third party testing and conformity assessment, as required
 Options considered and actions taken to reduce or eliminate any risk
 SAFETY IN PRODUCTION

 Development of a culture of
product safety in the production
facility
 Reduction or elimination of
product defects
 Commitment to consumer
product safety
 Industry best practices
 PRODUCTION PLANNING
A production facility should plan its production before the start of
manufacturing by
 confirming that they have the final design to be used for actual
production;
 reviewing any prototypes built prior to production; and
 completing a pre-production run.
 PRODUCTION SUPPORT

Production support provides the production facility with capabilities such as

the following:
 the auditing of production to ensure consistency;
 the monitoring of the regulatory and standards environment to ensure
compliance;
 the monitoring of continual improvement processes;
 the meeting of documentation requirements.
 SAFETY IN THE MARKETPLACE

 To improve consumer product safety, suppliers should conduct pre-

purchase confirmation, proactive data collection, and ongoing
product risk assessment
 Warranty and servicing

-A supplier may be required to provide continued support after the

consumer product is sold to the consumer including installation,
warranty, servicing, repair or providing replacement parts. Suppliers
may provide this assistance directly or may delegate this function to
other parts of the supply chain or third party service organizations.
 CONSUMER PRODUCT RECALL
The supplier should have in place a product recall plan that includes the following:
1) The recall policy
2) Documentation and records that will be created and maintained
3) Regulatory requirement
4) Expertise required to manage a recall
5) Training for recall
6) Guidance on how product incidents will be investigated and a decision made on
whether a recall is necessary
7) Identification of the resources required and processes used to implement a
recall
8) Establishing the requirement for continual improvement of the supplier’s
processes
 CONSUMER PRODUCT RECALL
1) The recall policy
 The supplier should develop and maintain a product recall policy
and identify how decisions will be made to carry out a product
recall.
2) Documentation and records that will be
created and maintained
 Such as records of consumer complaints
and product safety incidents, evidence of
the effectiveness of the recall, including
return rates, effectiveness per method of
communication and evidence to show that
the recall is working, financial records etc
3) Regulatory requirement
 The supplier should identify, monitor, understand and comply
with applicable legislative, regulatory and standard
requirements for recalls, in all markets where a consumer
product is produced in or sold
4) Expertise required to manage a recall
- Suppliers may need outside assistance from advisors and consultants
regardless of size.
The objectives of the people responsible for managing the recall are as
follows:
i. assess all available information and determine the actions necessary to do
the following:
a) protect the health or safety of consumers
b) maintain relationships with consumers and stakeholders
c) protect the reputation of the supplier
d) fulfil all relevant legal obligations (e.g. mandatory reporting) in all
countries of distribution
ii) liaise with relevant government and industry authorities;

iii) ensure that key stakeholders are kept informed of the supplier’s
decisions and actions, including forthcoming media communications;

iv) ensure that decisions and recall actions are implemented

effectively with the least amount of disruption to the normal
operation of the supplier’s day-to-day business.
5) Training for recall
- Planning, training and conducting recall simulations will help to better
prepare people for a recall and also increase the likelihood that agreed
processes are implemented quickly and effectively under conditions
that can be stressful. In addition, these activities may be required to
meet contractual, legal and insurance requirements
6) Guidance on how product incidents will be investigated and a
decision made on whether a recall is necessary

1. Incident
notification

5. Product 2. Incident
recall investigation
decision

4. 3. Assess
Traceability the risk

ASSESSING THE NEED FOR PRODUCT RECALL

 7) Identification of the resources required and processes used
to implement a recall
1. Initiate the recall

2. Communicate

3. Implement the recall

Expansion Adjust
of recall recall
4. Monitor and report

5. Evaluate effectiveness of the recall

6. Review and adjust recall strategy

 8) Establishing the requirement for continual
improvement of the supplier’s processes

Reviewing Corrective actions may

the recall include:
1) Materials
2) Design
3) Production process
CONTINUOUS 4) Production
IMPROVEMENT monitoring
5) Product safety
standard
Corrective 6) Packaging
actions to 7) Shipping
prevent 8) Storage
recurrence 9) Product markings
10)Instructions