Potential Product Safety Concern (PPSC)

Work Instruction
Proprietary and Confidential YFAI-SM-WI-08-02-E Rev 01 Page 1 of 7

Revision Release Date Description of Changes

01 30-June-2016  Initial release

Approved and Released

Vice President and General Manager Vice President and General Manager Vice President and General Manager
(NA) (EMEA) (AP)
Nathan Bowen Jochen Heier Yuan Xinhua
Vice President – Manufacturing Excellence and Quality BOS Manager
Joel Beezhold Darlene Dehaan

1.0 Purpose

This Work Instruction defines the process for initiating, tracking and resolving Potential Product Safety
Concerns (PPSCs), to ensure that YFAI is taking action to resolve PPSCs, to ensure concerns are not
repeated and to eliminate any unreasonable risk to YFAI due to a designed or manufactured product. The
opening of a PPSC investigation is not a determination that a safety risk has been identified. The opening
of the PPSC is the first step in the investigation that may result in a finding of no concern, of a non-safety
deviation from customer requirements, or potentially a safety concern.

2.0 Scope

This applies to all worldwide locations of Yanfeng Automotive Interiors.

3.0 Process Owners

PPSC Owner
Plant Quality Manager, Engineering Manager, Supplier Quality Manager
Product Safety Lead
PPSC Team
Safety Engineering Manager / Director
Quality Director (NA and EMEA)
Production Quality and Safety Technology Committee (AP)

Master files are stored electronically and are available to all team members.
Printed copies of the master files are for reference only.
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4.0 Process

Process Output Process Owner

Concern Identified

Employee (Identified Issue), Quality

Report to Responsible Manager(s) PPSC Notification - Email(s) Manager, Engineering Manager, Supplier
and Complete Required Notifications Quality Manager

Product Safety Lead and / or Safety

Review Concern Engineering Manager / Director (EMEA),

Follow
Open No Corrective PPSC Form or 8D / Equiv. Quality Director (EMEA/NA) or Production
PPSC? Action Process Quality and Safety Technology
to Solve Issue Committee (AP), Plant Quality Manager

Yes

Implement Containment PPSC Form with Supporting Plant Quality Manager and PPSC owner
Information

Classify
PPSC PPSC Form Product Safety Lead and PPSC Owner

Yes Notify
Notify Email or other Communication Quality Director (EMEA/NA) or Production
Customer Customer Method Quality and Safety Technology
? Committee (AP), with Regional VP / GM
or CBU GM
No

Announce PPSC Opening PPSC Announcement Email

Product Safety Lead

Schedule and Conduct Invitation for PPSC Kick Off

PPSC Kick-Off Meeting meeting Product Safety Lead

Update PPSC form and PPSC form and Tactical Plan

Tactical Plan PPSC owner with Product Safety Lead
and PPSC team

Recall Yes Follow Recall

Occurs? Management Quality Director
Work Instruction

No

A
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4.0 Process

Process Output Process Owner

A

Suspect Definition and scheduling of Product Safety Lead and Safety

Product Yes Suspect Product Assessment, Engineering Manager / Director (EMEA)
Assessment results report
Needed?
Define and conduct Safety Engineering Manager / Director
Assessment (EMEA)
NOK OK
No
Follow Corrective Approval to use 8D Quality Director
Action Process to / Equivalent
Solve Issue

Determine PPSC Form with Supporting Tools PPSC Owner, Safety Engineering
Root Cause and Documents Manager / Director (EMEA), PPSC team

PPSC Form with Supporting Tools PPSC Owner, Safety Engineering

Verify Root Causes and Documents Manager / Director (EMEA), PPSC Team

Updated Tactical Plan PPSC Owner with Product Safety Lead

Update PPSC Tactical Plan and PPSC Team

Updated PPSC Form with PPSC Owner, Safety Engineering

Supporting Documents Manager / Director (EMEA)
Validate
Product and Process

Finalized PPSC form and Tactical PPSC owner with Product Safety Lead
Finalize / Resolve PPSC Plan

Review PPSC Status /

Verify Evidence and Closure Evidence Product Safety Lead
Submit for Closure

Close No PPSC Form Quality Director (EMEA/NA) or Production

PPSC? Quality and Safety Technology
Committee (AP)

Yes
PPSC closure announcement
Close and Communicate
email. Product Safety Lead
PPSC Closure

PPSC Resolved
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4.1 General Definitions and Foundational Requirements:

4.1.1 PPSC Roles:

 PPSC Owner - Plant Quality Manager, Engineering Manager, or Supplier Quality
Manager with the responsibility to lead all PPSC actions for Manufacturing issues,
engineering issues or Supplier issues as identified in the Tactical Plan.
 Product Safety Lead - Individual assigned as project manager of the PPSC; designated
to coach the team through the closure process and review the PPSC prior to presenting it
to the Quality Director for closure. The Product Safety Lead uses the PPSC form and
Tactical Plan to review all work related to the concern.
 PPSC Champion - The Quality Director has the responsibility to remove roadblocks for
funding and resources, or further escalate them and the Quality Director or Safety
Engineering Director has the responsibility to remove roadblocks for root cause analysis
and testing or further escalate them.
 Production Quality and Safety Technology Committee (AP-region): This committee
consists of VP / Executive Director Product Engineering & Product Process, Engineering
Director, Quality Director, Production Validation Director, Manufacturing Engineer
Director, Supplier Quality Director, Program Director and Safety Engineer. The PQSC
will make final decisions about the PPSC. The chairman of the PQSC is the VP Product
Engineering & Product Process.

4.1.2 PPSC Criteria: The opening of a PPSC must be considered after reviewing and confirming
the concern if any of the following criteria apply during Phase 5 or after start of production.
The opening of a PPSC can be considered during Phase 4 when suspect parts might be
assembled in customer vehicles.

 Potential or known noncompliance to regulatory requirements;

 Potential or known noncompliance to a customer safety requirement;
 Potential or known noncompliance to due care product safety requirements, which are
defined as critical characteristic (CC) by YFAI;
 Potential or known noncompliance to a product safety related process control or Process
Poka Yoke (as defined in the production Control Plan);
 A previously undefined / undetected product safety risk;
 Note: The opening criterion above is independent of whether an actual suspect part is
found.

4.2 Concern Identified: Employees notify their Manager if they identify an unconfirmed issue that is
anticipated or known to meet PPSC criteria.

4.3 Report to Responsible Manager(s) and Complete Required Notifications:

4.3.1 All internally found issues must be reported by the Employee who identified it to the
responsible Quality Manager, Engineering Manager or Supplier Quality Manager in timing
according to the “No Surprise Communication Standard”.

4.3.2 The responsible Quality Manager, Engineering Manager or Supplier Quality Manager shall
notify the Product Safety Lead and Safety Engineering Manager / Director (EMEA) when they
identify or receive a report for an unconfirmed issue that is anticipated or known to meet
PPSC criteria.

Note: All internally found issues must be reported according to the No Surprise Communication
Standard.
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4.4 Review Concern: The Product Safety Lead and / or Safety Engineering Manager / Director (EMEA)
must review the concern to determine if it must be escalated to the Quality Director as a Potential
Product Safety issue based on the defined PPSC criteria. If the concern meets the PPSC criteria, the
Product Safety Lead must notify the Quality Director according to the No Surprise Communication
Standard.

4.5 Open PPSC? The Quality Director or the Production Quality and Safety Technology Committee (AP-
region) makes the decision to open a PPSC. If the issue is not a PPSC, the Plant Quality Manager
resolves the quality issue using the corrective action process and necessary tools.

4.6 Implement Containment:

4.6.1 The responsible Plant Quality Manager shall assign a PPSC Owner, and immediately
determine, implement and verify the necessary containment actions at all affected locations.
Containment actions taken are documented on the PPSC form.

4.6.2 The PPSC owner must provide written evidence and/or meeting minutes to the Product
Safety Lead if the customer does not request containment actions for suspect parts delivered
to the customer. Written evidence may include:
 Documentation from the customer or communicated meeting minutes stating that YFAI
does not have to exchange suspect parts delivered to the customer.
 Document stating that the customer will coordinate all remaining containment actions.

4.7 Classify PPSC: The Product Safety Lead determines the PPSC classification as internal, external or
Repeat-PPSC. A PPSC is categorized as external if the development and quality responsibility for
the parts of concern lies outside of YFAI. If at any point in the PPSC process it is determined that
YFAI is not responsible for the corrective action necessary to resolve the issue, the PPSC can be
recommended for closure.

4.7.1 External PPSC: The customer or third party is responsible for root cause investigation and
the approval, verification and implementation of countermeasures associated with this
external concern.

4.7.2 Evidence of external PPSCs: The PPSC owner must provide written evidence or meeting
minutes to the Product Safety Lead for approval to be classified as an external PPSC – if
possible - before the end of the reporting month. If the PPSC is classified as external with
sufficient evidence, the PPSC is closed. Written evidence may include:
 Document from the customer or communicated meeting minutes stating that YFAI is not
responsible for the concern.
 Statement of work with RASIC showing Roles/Responsibility is the Customer’s and not
YFAI’s.
 Statement of customer which says YFAI does not have to change any owned part or
process.
 Document stating the customer will coordinate closing the concern with the third party.
 Customer contract for the directed parts including RASIC showing responsibility for
concern is not YFAI’s.
 Customer pays for changes to close concern.

4.8 Notify Customer? The Quality Director (EMEA/NA) or Production Quality and Safety Technology
Committee (AP) makes the decision about the need to notify the customer, in cooperation with the
regional Vice President / General Manager or the regional General Manager of the CBU. The
Quality Director shall organize the necessary communication to the customer.
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4.9 Announce PPSC Opening: The Product Safety Lead must send a PPSC opening announcement
email with the initial PPSC form and all available information to inform Senior Management, the
affected plant(s), Legal Department (if required), Program Management and all other regional
Product Safety Leads in accordance with the No Surprise Communication Standard.

4.10 Schedule and Conduct PPSC Kick-Off Meeting: The Product Safety Lead schedules and conducts
the Kick-Off Meeting with the PPSC team.

4.11 Update PPSC form and Tactical Plan:

4.11.1The PPSC Owner, supported by the Product Safety Lead and PPSC team updates the PPSC
form, and creates the Tactical Plan during the kick-off and ongoing PPSC meetings. The
PPSC Owner continues to update the Tactical Plan for ongoing PPSC meetings.

4.11.2PPSC Target Dates are 15 days for root cause, and an additional 45 days for completion of
permanent corrective actions. If responses are behind to meet these PPSC target dates, or
there is risk of not completing them on time, the PPSC Leader must schedule a Team review
with the Vice President of Manufacturing Excellence and Quality for approval / review of the
plan.

4.11.3The Product Safety Lead must schedule ongoing PPSC meetings for a regular review of the
PPSC status.

4.12 Recall Occurs? If a Recall occurs due to the PPSC, follow the Recall Management Work Instruction.

4.13 Suspect Product Assessment Needed? The Safety Engineering Manager / Director and the Product
Safety Lead shall determine whether an assessment is needed.

4.22.1 If a Suspect Process Assessment is needed, the Product Safety Lead and Safety Engineering
Manager / Director (EMEA) defines the type / methods used for the assessment and is
responsible for scheduling and ensuring completion of the risk assessment in order to confirm
or deny a Product Safety concern. The results must be reported to the PPSC team.

4.12.2 If the Suspect Product Assessment confirms there is no deviation from regulatory and
customer safety requirements, the PPSC can be managed as a quality issue according to
Preventive and Corrective Action procedure with the approval from the Quality Director.

4.14 Determine Root Cause: The PPSC Owner, PPSC Team and Safety Engineering Manager / Director
(EMEA) must use the necessary tools for Root Cause Analysis and determine all potential root
causes and select probable root causes for "why made" and "why shipped".

4.15 Verify Root Causes: The PPSC Owner, PPSC Team and the Safety Engineering Manager / Director
(EMEA) verify probable root causes for "why made" and "why shipped" to confirm real root cause.
Verification requires that the issue can be repeated by applying the root cause. They can be
supported by further Root Cause Analysis experts.

4.16 Update PPSC Tactical Plan:

4.16.1The PPSC Owner, supported by the Product Safety Lead and the PPSC Team, continually
update the Tactical Plan with all activities, results, start & end dates and responsibilities in
order to identify all necessary corrective and preventive actions necessary to close the
PPSC. The Tactical Plan is part of the PPSC form (workbook. Significant scope changes in
the PPSC shall be reported according to the No Surprise Communication Standard.
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4.16.2If there is risk that the PPSC Tactical Plan actions will not be completed within 90 days from
the open date of the PPSC, an escalation review shall be scheduled by the PPSC Leader
with the PPSC Team and Vice President of Manufacturing Excellence and Quality. This
review must be conducted prior to the 90 day due date.

4.17 Validate Product and Process: The PPSC Owner and Safety Engineering Manager / Director
(EMEA) shall validate the product and process after corrective actions are fully implemented in order
to ensure that corrective actions were effective.

4.18 Finalize / Resolve PPSC: The PPSC Owner supported by the Product Safety Lead must ensure that
all necessary actions as identified in the Tactical Plan are completed for the PPSC closure and fully
documented.

4.19 Review PPSC Status / Verify Evidence and Submit for Closure: The Product Safety Lead shall
review the PPSC closure evidence for completion, and submit to the Quality Director for the closure
decision.

4.20 Close PPSC? The Quality Director (EMEA/NA) or Production Quality and Safety Technology
Committee (AP) reviews the closure evidence and requests additional evidence or actions until the
final decision to close the PPSC is made. Besides the evidence of the Tactical Plan, the additional
evidence includes the following items, when applicable.
 Internal / external PPAP, if applicable due to an engineering or process change
 Customer feedback on PPSC closure for external PPSCs (see 4.7.2 Evidence of external
PPSCs) and for internal PPSCs, if applicable due to containment actions for instance
 In case of no customer feedback, when it is actually applicable, a clear statement should
be sent to the customer in order to describe that all identified actions are implemented
and that the PPSC will be closed.

4.21 Announce PPSC closure: The Product Safety Lead must send a PPSC closure announcement
email with the completed PPSC form and all corrective action supporting documents and data as
Lessons Learned information to all involved PPSC team members and to inform Senior
Management. All PPSCs must also be communicated by the Product Safety Lead to each regional
Product Safety Lead, who will then communicate the closed PPSC within their respective regions.

5.0 Records/Logs

The closed PPSC form including the Tactical Plan and all supporting evidence are stored by the Product
Safety Lead. All documents and records shall be archived according to regional requirements.

6.0 References

Potential Product Safety Concern (PPSC) Workbook (YFAI-SM-FR-08-02)

Preventive and Corrective Actions Process (YFAI-SM-PO-08)
No Surprise Communication Standard (YFAI-SM-ST-00-01-E)
Recall Management Work Instruction (YFAI-SM-WI-08-03)