Product Safety and Conformity Representative

(PSCR)

13.12.2021 Elaboró: Desarrolo de Proveedores Versión 1

 Objetives

1 Understand what Product Safety and Conformity are

2 To know Safety and Product Conformity requirements

3 Product Safety Application in the Supply Chain

Versión 1 Product Safety and Conformity 2

13.12.2021 Prepared by: Supplier Development
 Agenda

1. Background

2. Key Concepts

3. Why to assign a product safety and

conformity Representative (PSCR) Welcome to PSCR
training
4. Responsibility and Competences of a
PSCR
5. Product integrity during it´s life cycle

6. Product Liability Requirements for

Manufacturers

Versión 1 Product Safety and Conformity 3

13.12.2021 Prepared by: Supplier Development
 1 BACKGROUND

Versión 1 Product Safety and Conformity 4

13.12.2021 Prepared by: Supplier Development
Background

The automotive industry is shifting gears. Global disruption, technological

advances, and changing consumer behaviors are altering the auto industry
on many levels all at once.

OEM’s and their suppliers when manufacturing or assembling automotive

parts are responsible for the quality of the product and its
performance in the field.

13.12.2021 Prepared by: Supplier Development Versión 1 Product Safety and Conformity 5
Background

NHTSA Recalls Trend 1997 – 2017 chart

The increase in recalls, complexity of vehicles and compliance with government requirements
have led to greater attention to the safety that a car offers.

13.12.2021 Prepared by: Supplier Development Versión 1 Product Safety and Conformity 6
 2 KEY CONCEPTS

Versión 1 Product Safety and Conformity 7

13.12.2021 Prepared by: Supplier Development
Key Concepts

 PRODUCT SAFETY.

13.12.2021 Prepared by: Supplier Development Versión 1 Product Safety and Conformity 8
Key Concepts

 PRODUCT SAFETY. Standards related to the design and manufacture of products

to ensure that they do not represent harm or danger to customers

13.12.2021 Prepared by: Supplier Development Versión 1 Product Safety and Conformity 9
Key Concepts

 PRODUCT SAFETY. Standards related to the design and manufacture of products

to ensure that they do not represent harm or danger to customers

 PRODUCT CONFORMITY.

13.12.2021 Prepared by: Supplier Development Versión 1 Product Safety and Conformity 10
Key Concepts

 PRODUCT SAFETY. Standards related to the design and manufacture of products

to ensure that they do not represent harm or danger to customers

 PRODUCT CONFORMITY. All processes, products and services provided must

comply with the applicable legal and regulatory requirements of the exporting
country, importing country, and the country of destination specified by the
customer.

13.12.2021 Prepared by: Supplier Development Versión 1 Product Safety and Conformity 11
Key Concepts

 PRODUCT SAFETY. Standards related to the design and manufacture of products

to ensure that they do not represent harm or danger to customers

 PRODUCT CONFORMITY. All processes, products and services provided must

comply with the applicable legal and regulatory requirements of the exporting
country, importing country, and the country of destination specified by the
customer.

 PRODUCT SAFETY AND CONFORMITY REPRESENTATIVE (PSCR).-

13.12.2021 Prepared by: Supplier Development Versión 1 Product Safety and Conformity 12
Key Concepts

 PRODUCT SAFETY. Standards related to the design and manufacture of products

to ensure that they do not represent harm or danger to customers

 PRODUCT CONFORMITY. All processes, products and services provided must

comply with the applicable legal and regulatory requirements of the exporting
country, importing country, and the country of destination specified by the
customer.

 PRODUCT SAFETY AND CONFORMITY REPRESENTATIVE (PSCR).- A person

responsible for the safety of the product and checks that the legal and regulatory
requirements of the same are met.
PSCR (Responsible for Product Safety and Compliance) is a recent evolution
of the PSB (Responsible for Product Safety)

13.12.2021 Prepared by: Supplier Development Versión 1 Product Safety and Conformity 13
Key Concepts

 PRODUCT SAFETY. Standards related to the design and manufacture of products

to ensure that they do not represent harm or danger to customers

 PRODUCT CONFORMITY. All processes, products and services provided must

comply with the applicable legal and regulatory requirements of the exporting
country, importing country, and the country of destination specified by the
customer.

 PRODUCT SAFETY AND CONFORMITY REPRESENTATIVE (PSCR).- A person

responsible for the safety of the product and checks that the legal and regulatory
requirements of the same are met.
PSCR (Responsible for Product Safety and Compliance) is a recent evolution
of the PSB (Responsible for Product Safety)

 PRODUCT INTEGRITY (PI) .-

13.12.2021 Prepared by: Supplier Development Versión 1 Product Safety and Conformity 14
Key Concepts

 PRODUCT SAFETY. Standards related to the design and manufacture of products

to ensure that they do not represent harm or danger to customers

 PRODUCT CONFORMITY. All processes, products and services provided must

comply with the applicable legal and regulatory requirements of the exporting
country, importing country, and the country of destination specified by the
customer.

 PRODUCT SAFETY AND CONFORMITY REPRESENTATIVE (PSCR).- A person

responsible for the safety of the product and checks that the legal and regulatory
requirements of the same are met.
PSCR (Responsible for Product Safety and Compliance) is a recent evolution
of the PSB (Responsible for Product Safety)

 PRODUCT INTEGRITY (PI) .- Product safety and conformity

Product Integrity (PI)

Product Safety Product Conformity

13.12.2021 Prepared by: Supplier Development Versión 1 Product Safety and Conformity 15
Key Concepts

Product Safety Product Conformity

In average 41.6 million vehicles with 56

million defective Air Bags

13.12.2021 Prepared by: Supplier Development Versión 1 Product Safety and Conformity 16
Key Concepts

 GOVERNMENT AGENCIES. The governments of the countries through their

dependencies in charge of the Safety of Motor Vehicles submit the regulations and
standards of Vehicle Safety and are in charge of monitoring its compliance.

Examples of Government Agencies

Networking between
Government Agencies

13.12.2021 Prepared by: Supplier Development Versión 1 Product Safety and Conformity 17
 WHY TO ASSIGN A PRODUCT SAFETY AND CONFORMITY
3 REPRESENTATIVE (PSCR)

Versión 1 Product Safety and Conformity 18

13.12.2021 Prepared by: Supplier Development
 WHY TO ASSIGN A PRODUCT SAFETY AND
CONFORMITY REPRESENTATIVE (PSCR)

Rules, regulations, contractual requirements ...

IATF 16949 – 4.4.1.2 Product Safety.

The organization must have a

documented process for managing
product safety, related to products and
manufacturing processes.
New IATF 16949 (2016) content
Product safety

VDA – Product Integrity Manual

Versión 1 Product Safety and Conformity 19

13.12.2021 Prepared by: Supplier Development
 WHY TO ASSIGN A PRODUCT SAFETY AND
CONFORMITY REPRESENTATIVE (PSCR)

 Complex Technology.
 Flexibility and Quality in Manufacturing sites.
 Accelerate the development cycles.
 Security Expectations of Customers and Legislators.
 More demanding laws and regulations.

Versión 1 Product Safety and Conformity 20

13.12.2021 Prepared by: Supplier Development
Non-Compliance potential impact

 Human lives at risk

 Generate loss of car primary function
 Create part assembly problems
 Civil Liability and damages to third parties
 Generate expenses to the company (fines)
 Loss of Company prestige image

13.12.2021 Prepared by: Supplier Development Versión 1 Product Safety and Conformity 21
 4 RESPONSIBILITY AND COMPETENCES OF A PSCR

Versión 1 Product Safety and Conformity 22

13.12.2021 Prepared by: Supplier Development
Responsibility of the company

Overall responsibility

Responsibility

Corporate overall responsibility is

Level under Top Management duty
organization
Board of directors
Because management CAN NOT
perform individual tasks /
Classic business structure in terms of responsibility
responsibilities can be delegated.

Overall Responsibility Responsibility

Task Task Task Task

Task Task

13.12.2021 Prepared by: Supplier Development Versión 1 Product Safety and Conformity 23
 Competencies related to PSCR

 Ideally not a new employee

 Have skills such as problem management, assertiveness

 Ability to negotiate with government and regulatory bodies

 Sufficient resources to carry out the obligations

 Understanding / Sensitivity to the scope of responsibility

13.12.2021 Prepared by: Supplier Development Versión 1 Product Safety and Conformity 24
 PSCR Qualification

 Problem solving methods  Product safety prevention

 Market supervision  Product tracking
 Obligation of information on product safety to authorities  Product Knoweledge
or customers  Ensure quality prevention
 Product safety and responsibility  Document processing

 Customer specific requirements (security)

 Knowledge of specific products of the company

 Product traceability, verification, elimination and handling of non-conforming products

 Identification of discrepancies related to product safety

 Guidelines for internal and external communication in the event of a product safety event
 Risk management and analysis
 Management of safety-related product discrepancies, including conclusion
 Learned lessons

 Specific Requirements  Specific Products  Specific Process

13.12.2021 Prepared by: Supplier Development Versión 1 Product Safety and Conformity 25
 Information flow, steps of a notification

Authority

Product Users
Suppliers Suppliers

Commerce

Decision-Making Committee, which is made up of the following functions:

 Quality
 Production
 Product Safety
 Product Conformity
 Product development
 Sales
 Logistics
 Customer service
 Legal

Versión 1 Product Safety and Conformity 26

13.12.2021 Prepared by: Supplier Development
 5 PRODUCT INTEGRITY DURING ITS LIFE CYCLE

Versión 1 Product Safety and Conformity 27

13.12.2021 Prepared by: Supplier Development
 Product integrity during its life cycle

Market
Monitoring

REQUIREMENTS DEVELOPMENT PRODUCTION

PHASE PHASE PHASE

USE PHASE Reaction to

the risks of
the product in
the field

Versión 1 Product Safety and Conformity 28

13.12.2021 Prepared by: Supplier Development
 Product integrity during its life cycle

 Design and production approvals

 Functional Specifications Based
on Lessons Learned
 Selection of products, assemblies
or functional groups from a PI
perspective
Market
Monitoring

REQUIREMENTS DEVELOPMENT PRODUCTION

PHASE PHASE PHASE

Determine compliance
with product legal USE PHASE Reaction to
requirements and the the risks of
reasonable end the product in
customer safety
expectations
the field

Versión 1 Product Safety and Conformity 29

13.12.2021 Prepared by: Supplier Development
 Product integrity during its life cycle

 Design and production approvals  Products used with a similar context

 Functional Specifications Based  Creation of PI requirements and their
on Lessons Learned adaptation to specific products
 Selection of products, assemblies  Use appropriate processes to ensure
or functional groups from a PI compliance with Laws and Regulations
perspective  PI - Traceable and documented
Market
Monitoring

REQUIREMENTS DEVELOPMENT PRODUCTION

PHASE PHASE PHASE

Determine compliance
with product legal USE PHASE Reaction to
requirements and the the risks of
reasonable end the product in
customer safety
expectations
the field

Versión 1 Product Safety and Conformity 30

13.12.2021 Prepared by: Supplier Development
 Product integrity during its life cycle

 Design and production approvals  Products used with a similar context  Line Walk
 Functional Specifications Based  Creation of PI requirements and their  CoP – Conformity of product /
on Lessons Learned adaptation to specific products Legal Requirements
 Selection of products, assemblies  Use appropriate processes to ensure  PI indicators
or functional groups from a PI compliance with Laws and Regulations  PI training to the plant
perspective  PI - Traceable and documented
Market
Monitoring

REQUIREMENTS DEVELOPMENT PRODUCTION

PHASE PHASE PHASE

Determine compliance
with product legal USE PHASE Reaction to
requirements and the the risks of
reasonable end the product in
customer safety
expectations
the field

Versión 1 Product Safety and Conformity 31

13.12.2021 Prepared by: Supplier Development
 Product integrity during its life cycle

 Design and production approvals  Products used with a similar context  Line Walk
 Functional Specifications Based  Creation of PI requirements and their  CoP – Conformity of product/
on Lessons Learned adaptation to specific products Legal Requirements
 Selection of products, assemblies  Use appropriate processes to ensure  PI indicators
or functional groups from a PI compliance with Laws and Regulations  PI training to the plant
perspective  PI - Traceable and documented
Market
Monitoring

REQUIREMENTS DEVELOPMENT PRODUCTION

PHASE PHASE PHASE

Determine compliance
with product legal USE PHASE Reaction to
requirements and the the risks of
reasonable end the product in
customer safety  Tracking the
expectations
the field
product until its
recycling
 Market Monitoring
 Warranty Follow-up

Versión 1 Product Safety and Conformity 32

13.12.2021 Prepared by: Supplier Development
 Product integrity during its life cycle

 Design and production approvals  Products used with a similar context  Line Walk
 Functional Specifications Based  Creation of PI requirements and their  CoP – Conformity of Product /
on Lessons Learned adaptation to specific products Legal Requirements
 Selection of products, assemblies  Use appropriate processes to ensure  PI indicators
or functional groups from a PI compliance with Laws and Regulations  PI training to the plant
perspective  PI - Traceable and documented
Market
Monitoring

REQUIREMENTS DEVELOPMENT PRODUCTION

PHASE PHASE PHASE

Determine compliance
with product legal USE PHASE Reaction to
requirements and the the risks of
reasonable end the product in
customer safety  Tracking the
expectations
the field
product until its
recycling
 Market Monitoring
 Warranty Follow-up

RISK ASSESSMENT
Versión 1 Product Safety and Conformity 33
13.12.2021 Prepared by: Supplier Development
 PRODUCT LIABILITY REQUIREMENT FOR MANUFACTURERS
6

Versión 1 Product Safety and Conformity 34

13.12.2021 Prepared by: Supplier Development
 Obligations and participation of the PCSR

1. Identify and monitor legal and regulatory

requirements on the integrity of the product,
as well as its customer information.

Versión 1 Product Safety and Conformity 35

13.12.2021 Prepared by: Supplier Development
 Obligations and participation of the PCSR

1. Identify and monitor legal and regulatory

requirements on the integrity of the product,
as well as its customer information.

2. Identify the characteristics related to

product safety, both by the customer and
by the supplier.

Versión 1 Product Safety and Conformity 36

13.12.2021 Prepared by: Supplier Development
 Obligations and participation of the PCSR

1. Identify and monitor legal and regulatory

requirements on the integrity of the product,
as well as its customer information.

2. Identify the characteristics related to

product safety, both by the customer and
by the supplier.

3. Approve the safety requirements of the

product and its controls in Control Plans,
design FMEA and process FMEA.

Versión 1 Product Safety and Conformity 37

13.12.2021 Prepared by: Supplier Development
 Obligations and participation of the PCSR

1. Identify and monitor legal and regulatory

requirements on the integrity of the product,
as well as its customer information.

2. Identify the characteristics related to

product safety, both by the customer and
by the supplier.

3. Approve the safety requirements of the

product and its controls in Control Plans,
design FMEA and process FMEA.

4. Identify the controls at the points of

manufacture of the characteristics related
to the integrity of the product.

Versión 1 Product Safety and Conformity 38

13.12.2021 Prepared by: Supplier Development
 Obligations and participation of the PCSR

1. Identify and monitor legal and regulatory

requirements on the integrity of the product,
as well as its customer information.

2. Identify the characteristics related to

product safety, both by the customer and
by the supplier.

3. Approve the safety requirements of the

product and its controls in Control Plans,
design FMEA and process FMEA.

4. Identify the controls at the points of

manufacture of the characteristics related
to the integrity of the product.

5. Define reaction plans to address any

deviation from Product Integrity.

Versión 1 Product Safety and Conformity 39

13.12.2021 Prepared by: Supplier Development
 Obligations and participation of the PCSR

6. Appoint those responsible for decision-

making and information flow in the
escalation process (including senior
management and, where appropriate,
customer notification)

Versión 1 Product Safety and Conformity 40

13.12.2021 Prepared by: Supplier Development
 Obligations and participation of the PCSR

6. Appoint those responsible for decision-

making and information flow in the
escalation process (including senior
management and, where appropriate,
customer notification)
7. Guarantee the correct training (competence)
for the people involved in product safety.

Versión 1 Product Safety and Conformity 41

13.12.2021 Prepared by: Supplier Development
 Obligations and participation of the PCSR

6. Appoint those responsible for decision-

making and information flow in the
escalation process (including senior
management and, where appropriate,
customer notification)
7. Guarantee the correct training (competence)
for the people involved in product safety

8. Define a control of changes in which

product integrity characteristics are involved,
as well as the evaluation of any potential
effect that such change could have.

Versión 1 Product Safety and Conformity 42

13.12.2021 Prepared by: Supplier Development
 Obligations and participation of the PCSR

6. Appoint those responsible for decision-

making and information flow in the
escalation process (including senior
management and, where appropriate,
customer notification)
7. Guarantee the correct training (competence)
for the people involved in product safety

8. Define a control of changes in which

product integrity characteristics are involved,
as well as the evaluation of any potential
effect that such change could have.

9. Have clear communication with the entire

supply chain of requirements regarding
product safety.

Versión 1 Product Safety and Conformity 43

13.12.2021 Prepared by: Supplier Development
 Obligations and participation of the PCSR

6. Appoint those responsible for decision-

making and information flow in the
escalation process (including senior
management and, where appropriate,
customer notification)
7. Guarantee the correct training (competence)
for the people involved in product safety

8. Define a control of changes in which

product integrity characteristics are involved,
as well as the evaluation of any potential
effect that such change could have.

9. Have clear communication with the entire

supply chain of requirements regarding
product safety.
10. Manage the lessons learned derived from
product safety and that are available for new
products.

Versión 1 Product Safety and Conformity 44

13.12.2021 Prepared by: Supplier Development
 Bocar and Customers PSCR
Requirements in Supply Chain
A. Definition of at least 2 people as responsible for the Safety and Conformity of
the product
B. Designation of roles and responsibilities
C. Send the contact details of the PSCR and the Plant Management
D. In case of any change in PSCR, notify Bocar customer
E. Availability of emergency care 24/7
F. No language barrier (Spanish / English)
G. Product Integrity Training by a qualified PSCR (qualification by a VDA-QMC
associate desirable)
H. Technical Training (knowledge of the product / process, problem solving
methodology, etc.)
I. Knowledge of Product Safety and Responsibility Laws
J. Implementation of Indicators for the evaluation of the integrity of the product

Versión 1 Product Safety and Conformity 45

13.12.2021 Prepared by: Supplier Development
Questions

Versión 1 Product Safety and Conformity 46

13.12.2021 Prepared by: Supplier Development