4.4.1 Product Safety

Chapter 9.
Product Safety Related
Contents:
0) Introduction
1) 4.4.1.2 Product Safety (IATF16949)
2) SIs & FAQs
3) Supplementary Notes
4) Exhibits
0) Introduction
There is only one applicable clause in this chapter. The reason why a whole chapter is devoted to this
is because the Clause is not commonly misunderstood and/or poorly catered for. Many NCs have been
written on this clause alone.
1) 4.4.1.2 Product Safety (IATF16949)

Clause Description-Paraphrase)
The organization shall have documented processes for the management of product-safety related
products and manufacturing processes, which shall include:
a) identification by the organization of statutory and regulatory product-safety requirements;

b) customer notification of requirements in item a);
c) special approvals for design FMEA;
d) identification of product safety-related characteristics;
e) identification and controls of safety-related characteristics of product and at the point of
manufacture;
f) special approval of control plans and process FMEAs;
g) reaction plans (see Section 9.1.1.1);
h) defined responsibilities, definition of escalation process and flow of information, including top
management, and customer notification;
i) training identified by the organization or customer for personnel involved in product-safety
related products and associated manufacturing processes;
j) changes of product or process shall be approved prior to implementation, including evaluation
of potential effects on product safety from process and product changes (see ISO 9001, Section
8.3.6); k) transfer of requirements with regard to product safety throughout the supply chain,
including customer-designated sources
l) product traceability
(Highlights of the clause)

• (Ref to old Standards) This is a totally new clause.
• The clause requires documented processes for the management of product-safety related
products and manufacturing processes
• The process shall have controls ranging from planning, implementation, checking and
corrective/improvement actions.
(Compliance Best Practice)
4.4.1.2 Product Safety

1
1. To comply to this clause, a documented process is required. See Exhibit 9-1.
2. The documented process must include the necessary controls stated in a) to l) of the
Clause description.
2) SIs & FAQs
SI No IATF Clause Description
FAQ IATF Clause Questions and Answers
2
FAQ IATF Clause Questions and Answers
3) Supplementary Notes
Legend: HOC= Highlights of Clause, CBP= Compliance Best Practice, S&Q= SIs & FAQ, EXH= Exhibits
Clause Section Clarification Subjects
4.4.1.2 CBP SN9.1. Why is safety repeated in so many places in the Standard?
4.4.1.2 CBP SN9.2. Isn’t it repeating, when product safety is already analysed
in FMEA, and Special & Critical Characteristics?
4.4.1.2 CBP SN9.3. Is product safety applicable for all organizations?
4.4.1.2 CBP SN9.4. How best can we do for handling safety products?
4.4.1.2 CBP SN9.5. Why bring in training into safety?
4.4.1.2 CBP SN9.6. Looks like Exhibit 9-1 does not have all the points given in
the Clause.
SN9.1. Why is safety repeated in so many places in the Standard?

Safety is a rising concern by governments and customers alike. It is critical requirement, and therefore
should be checked thoroughly. Standards writers will naturally hunt down the relevant areas and make
reminders.
SN9.2. Isn’t it repeating, when product safety is already analysed in FMEA, and Special
Characteristics?
For an IATF-certified organization, FMEA, risk and opportunity analyses, special & critical
characteristics marking, provide a good start to capture safety-related. But they may not be have
identified all. We need to take another look from another angle to exhaust the catch.
SN9.3. Is product safety applicable for all organizations?

No, some organization are not involved in safety-related products and therefore this clause does not
apply to them. They can safely declare non-applicability. However, you need to be sure of special
situations stated in FAQ-4. Your product may not be safety-related, but being used as a component to
a safety-related end-product. Suddenly your product may be classified safety-related.
SN9.4. How best can we do for handling safety products?

If product safety applies in your case, you need to establish a procedure for this requirement. This
procedure is best parked under a technical department such as Engineering, Production or QAQC. See
Exhibit 9-1 for a specimen of the Procedure. For training and competency, FAQ-13 should be taken as
a guide, and list down the requirement for HR to include in the training program.
3
After each project that involves product safety is completed, the activities should be checked by the
Product Safety Procedure.
SN9.5. Why bring in training into safety?

Any new subjects requires training, all the more critical and safety areas. Some customers may have
specific requirements regarding product safety, training, knowledge, and personnel. In this new
version, the compliance may include exports. See Chapter 19. It is the organization’s responsibility to
understand all these and include them into the QMS. HR will play a significant role in this area.
SN9.6. Looks like Exhibit 9-1 does not have all the points given in the Clause.
All points are already taken in, but may have been placed in different location. See the below where
the points are found in the steps in Exhibit 9-1. Numeral within parenthesis is the step no of the
procedure.
a) identification by the organization of statutory and regulatory product-safety requirements; (1)

b) customer notification of requirements in item a); (1)
c) special approvals for design FMEA; (1)
d) identification of product safety-related characteristics; (1)
e) identification and controls of safety-related characteristics of product and at the point of
manufacture; (1)
f) special approval of control plans and process FMEAs; (1)
g) reaction plans (see Section 9.1.1.1);
h) defined responsibilities, definition of escalation process and flow of information, including top
management, and customer notification; (2)
i) training identified by the organization or customer for personnel involved in product-safety related
products and associated manufacturing processes; (2)
j) changes of product or process shall be approved prior to implementation, including evaluation of
potential effects on product safety from process and product changes (see ISO 9001, Section 8.3.6);
(1)
k) transfer of requirements with regard to product safety throughout the supply chain, including
customer-designated sources (3)
l) product traceability (1)
4
4) Exhibits
Exhibit 9-1. Product Safety Management
>>End of Chapter 9 <<

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Chapter 9.

Product Safety Related

1) 4.4.1.2 Product Safety (IATF16949)

a) identification by the organization of statutory and regulatory product-safety requirements;

(Highlights of the clause)

(Compliance Best Practice)

4.4.1.2 Product Safety

2) SIs & FAQs

SI No IATF Clause Description

FAQ IATF Clause Questions and Answers

SN9.1. Why is safety repeated in so many places in the Standard?

SN9.3. Is product safety applicable for all organizations?

SN9.4. How best can we do for handling safety products?

SN9.5. Why bring in training into safety?

a) identification by the organization of statutory and regulatory product-safety requirements; (1)

Exhibit 9-1. Product Safety Management

>>End of Chapter 9 <<

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