Author: Jasson Zhang Approved by (if required): Jeff Wagner Original released date: 03/31/2017

Function: Global Supplier Quality Valid for – if other than resp. function: Nilfisk Doc. Number: QMS-6-070144
Language: English Document type: Work Instruction Rev. Number: 02
Process Failure Mode and Effect Analysis Effective date: 02/09/2018
Pages: 9

1.0 PURPOSE
To describe one of elements of Nilfisk Production Part Approval Process (PPAP) - Process Failure
Mode and Effect Analysis (PFMEA):
 To guide supplier when to submit/update PFMEA.
 To assure that potential failure modes of the process have been considered and addressed
– on critical characteristic(s) as minimum - to reduce risk of product non-conformity.

2.0 TABLE OF CONTENTS

1.0 PURPOSE ................................................................................................................................ 1
3.0 SCOPE ..................................................................................................................................... 1
4.0 ABBREVIATIONS/ACRONYMS ................................................................................................ 1
5.0 REFERENCE DOCUMENTS .................................................................................................... 2
6.0 PROCESS DIAGRAM ............................................................................................................... 2
7.0 RESPONSIBILITIES ................................................................................................................. 2
8.0 PROCEDURE ........................................................................................................................... 3
8.1 General Process: ...................................................................................................................................... 3
8.2 PFMEA instructions - Header................................................................................................................... 4
8.3 PFMEA instructions - elements ............................................................................................................... 5
8.4 PFMEA ranking tables .............................................................................................................................. 8
8.4.1 Severity ranking table ....................................................................................................................... 8
8.4.2 Occurrence ranking table ................................................................................................................. 8
8.4.3 Detection ranking table .................................................................................................................... 9
9.0 RECORDS ................................................................................................................................ 9
10. REVISION LOG ........................................................................................................................ 9

3.0 SCOPE
All direct material where PPAP process is used for part approval in line with PPAP submission level
requirement.

4.0 ABBREVIATIONS/ACRONYMS
ITEM DEFINITION
B1 Build 1(NPD project, engineering 1st build, design verification)
B2 Build 2 (NPD project, engineering 2nd build, process verification)
CC Critical Characteristics
NPD Nilfisk Product Development (new product development process)
PCP Process Control Plan
PCPA Process Control Plan Audit

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1
Author: Jasson Zhang Approved by (if required): Jeff Wagner Original released date: 03/31/2017
Function: Global Supplier Quality Valid for – if other than resp. function: Nilfisk Doc. Number: QMS-6-070144
Language: English Document type: Work Instruction Rev. Number: 02
Process Failure Mode and Effect Analysis Effective date: 02/09/2018
Pages: 9

PFD Process Flow Diagram

PFMEA Process Failure Mode and Effect Analysis
PPAP Production Part Approval Process
RPN Risk Priority Number
SOP Standard Operational Procedure
Supplier Quality Engineer – in this document both Global (GSQE)
SQE and Site (SQE) or SuBa engineer
SQPM Supplier Quality Project Manager
SRM Supplier Requirement Manual

5.0 REFERENCE DOCUMENTS

Type of Document Document Number Tile of Document
Template QMS-2-070058 PPAP forms
SOP QMS-1-070040 Production Part Approval Process (PPAP)
SOP QMS-0-070038 Supplier Requirement Manual (SRM)
SOP QMS-1-070051 Critical Characteristics
SOP QMS-1-070035 NPD Supplier Quality
Work Instruction QMS-6-070143 Process Control Plan
Work Instruction QMS-6-070142 Process Flow Chart
Standard NA AIAG – Potential Failure Mode and Effects Analysis

6.0 PROCESS DIAGRAM

NA

7.0 RESPONSIBILITIES
Supplier Quality Project Manager (SQPM)
1. Share NPD project time plan to supplier and SQE.
2. Define required PPAP submission level – in NPD PPAP list - and quality deliverables and
share with supplier and SQE.
SUPPLIER
1. Participate on PFMEA training delivered by SQE.
2. Read, understand and comply with this Work Instruction content.
3. Develop a preliminary PFMEA – for Build 1 - using an existing PFMEA on a similar part and
preliminary PFD, then present to SQE. Identify the TOP 10 high RPN risk area and develop
action plan to address them.
4. Update Build 1 PFMEA for Build 2 based on outcome of Build 1 and/or as changes are made
on product design or manufacturing process, then present to SQE. Implement actions of TOP
10 high RPN risk area.
5. Update Build 2 PFMEA for Pilot / Production based on outcome of Build 2 and/or as changes
are made on product design or manufacturing process, then present to SQE. Implement
actions of TOP 10 high RPN risk area.
6. Ensure the PFMEA was developed based on PFD and used for PCP development (based on
PPAP submission level).
7. Ensure all CCs are appropriately identified in PFMEA.

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 Author: Jasson Zhang Approved by (if required): Jeff Wagner Original released date: 03/31/2017
Function: Global Supplier Quality Valid for – if other than resp. function: Nilfisk Doc. Number: QMS-6-070144
Language: English Document type: Work Instruction Rev. Number: 02
Process Failure Mode and Effect Analysis Effective date: 02/09/2018
Pages: 9

8. Conduct periodic reviews on PFMEA - consider internal issues and/or customer complaints -
through the life of the product and use it as baseline to update PCP (as applicable).
9. Identify and communicate any changes to SQE on an ongoing-basis according to SRM
requirement.
10. Review PFMEAs of subcontractors (as applicable).
11. In case of PCPA audit by Nilfisk, present the latest version of PFMEA.
Supplier Quality Engineer (SQE)
1. Train supplier about PFMEA (as needed).
2. Review supplier’s B1 PFMEA with TOP 10 high RPN risk area and action plan, evaluate and
give feedback to supplier.
3. Review supplier’s B2 updated PFMEA, evaluate and give feedback to supplier. Monitor TOP
10 high RPN risk area actions, implementation status/result and give feedback to supplier.
4. Verify that Build 1&2 issues have been incorporated into the Pilot / Production PFMEA.
Monitor TOP 10 high RPN risk area actions, implementation status/result and give feedback
to supplier.
5. Review supplier’s Pilot / Production PFMEA, evaluate and dispose it based on PPAP SOP
through PPAP process. Update PPAP list once supplier’s PFMEA is approved.
6. Verify that the supplier used PFD and PFMEA and statistical data to determine what controls
are necessary (based on PPAP submission level).
7. Verify all CCs are identified and addressed in PFMEA.
8. Verify the PFMEA linked and in line with PCP and PFD. (as applicable).
9. Verify that the PFMEA covers each steps of the process, including receiving, in-process
operations, packaging, labeling and shipping.
10. Verify that any re-work processes are addressed in PFMEA.
11. Verify that the supplier updates the PFMEA on regular basis and in case of customer / internal
claims, issues.
12. In case of PCPA conducted; walk the production floor and verify that the controls listed on the
PFMEA/PCP are in place and being used. Complete the Process Control Plan Audit Checklist
as part of the audit of the production process.

8.0 PROCEDURE

PFMEA is a structured analytical tool to assure that potential failure modes of the process have
been considered and addressed – on critical characteristic(s) as minimum - to reduce risk of product
non-conformity.

8.1 General Process:

NPD project related parts: PFMEA development process starts in the production preparation phase
in parallel with R&D product development process;

1) SQPM share with supplier and SQE project product specific requirements such as supplier
quality deliverables and PPAP submission level requirement.
2) SQE may collect similar parts potential failure mode, the source would be:

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If this is a copy, unless otherwise specified, it is uncontrolled. You must verify the revision before use.
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 Author: Jasson Zhang Approved by (if required): Jeff Wagner Original released date: 03/31/2017
Function: Global Supplier Quality Valid for – if other than resp. function: Nilfisk Doc. Number: QMS-6-070144
Language: English Document type: Work Instruction Rev. Number: 02
Process Failure Mode and Effect Analysis Effective date: 02/09/2018
Pages: 9

 Lessons learned on similar products/parts

 Similar products Warranty data (e.g.: TFR, NPD TFR)
 Customer claims (e.g.: SCAR/8D) on similar parts
3) Supplier identify a cross-functional team (e.g.: Manufacturing, Engineering, Quality, Service, etc.)
for PFMEA.
4) Supplier initiate PFMEA that shall include critical error prevention and error detection ideas and
consider any lessons learned from previous projects.
5) Supplier develops PFMEA and updates it - as needed - for the different project build events
considering the feedback from Nilfisk. Submit PFMEA for evaluation to SQE.
6) Supplier defines TOP 10 High RPN risk area and address action plan to reduce them. Supplier
submit action plan to SQE for evaluation.
7) Supplier ensures that the current process controls and results of the recommended actions on
the PFMEA are listed in the PCP.
8) SQE evaluate the submitted PFMEA and give feedback to supplier at all project stages. Monitor
actions to TOP 10 High RPN risk area and evaluate if they are effective.
9) SQE evaluates and approves supplier PFMEA and inform SQPM and supplier. SQE update
document status in NPD PPAP list that stored at Nilfisk SharePoint.
10) SQE uploads approved Pilot/Production PFMEA to SharePoint as part of PPAP documentation
package according to PPAP SOP and inform SQPM, and update in PPAP list
11) Supplier maintains PFMEA, through life of the product and informs SQE in advance in case of
changes according to SRM requirements.

Non-NPD project related parts (e.g.: Sourcing projects): In case the part identified to be
approved with PPAP process and the part is technical approved by Nilfisk R&D, then SQE requires
from supplier to submit PFMEA together with other PPAP documentation based on PPAP
submission level requirement. SQE evaluates PFMEA together with other documents and makes
disposition based on PPAP SOP. Nilfisk SQE may verify the PFMEA together with other PPAP
documentation at supplier’s production facility.

8.2 PFMEA instructions - Header

Part Number (A): Enter the name and number of the system, subsystem or component for which
the process is being analysed.

Part Name (B): Enter description of the system, subsystem or component mentioned in Part Number
field.

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 Author: Jasson Zhang Approved by (if required): Jeff Wagner Original released date: 03/31/2017
Function: Global Supplier Quality Valid for – if other than resp. function: Nilfisk Doc. Number: QMS-6-070144
Language: English Document type: Work Instruction Rev. Number: 02
Process Failure Mode and Effect Analysis Effective date: 02/09/2018
Pages: 9

Supplier (C): Enter name of the supplier who submit the PFMEA.

Team (D): Enter the team members responsible for developing the PFMEA.

Rev. (E): Enter the actual revision of the system, subsystem or component mentioned in Part
Number field.

Process responsibility (F): Enter organization, and department or group who is process design
responsible.

FMEA Number (G): Enter alphanumeric string which is used to identify the PFMEA document. This
is used for document control.

Prepared by (H): Enter the name and contact information including the company of the team leader
responsible for preparing the PFMEA.

Date-Orig. (I): Enter the date when the original PFMEA was completed.

Date-Rev. (J): Enter the date when the PFMEA was updated.

8.3 PFMEA instructions - elements

Process Function/ Requirements (a): List the process function that corresponds to each process
step or operation being analysed. The process function describes the purpose or intent of the
operation. If there are multiple process functions being analysed with respect to a given operation,
each should be aligned on the form with its respective “Requirements” to aid in the development of
the associated failure modes. Furthermore, list the requirements for each process function of the
process step or operation being analysed. If there are multiple requirements for each process
information. If there are multiple requirements with respect to a given function, each should be
aligned on the form with the respective associated failure modes in order to facilitate the analysis.

Potential Failure Mode (b): Potential failure mode is defined as the manner in which the process
could potentially fail to meet the process requirements. List the potential failure mode(s) for the
particular operation in terms of the process requirement(s). Potential failure mode(s) should be
described in technical terms, not as a symptom noticeable by the customer.

Potential Effect(s) of Failure (c): Potential effects of failure are defined as the effects of the failure
mode as perceived by the customer(s). The effect of the failure should be described in terms of what
the customer might notice or experience, remembering that the customer may be an internal
(operations, locations) as well as the ultimate End User. If the failure mode could impact safety or
cause noncompliance to regulations, this should be clearly identified in the PFMEA. In order to
determine the Potential Effect(s), the following questions should be asked:

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If this is a copy, unless otherwise specified, it is uncontrolled. You must verify the revision before use.
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 Author: Jasson Zhang Approved by (if required): Jeff Wagner Original released date: 03/31/2017
Function: Global Supplier Quality Valid for – if other than resp. function: Nilfisk Doc. Number: QMS-6-070144
Language: English Document type: Work Instruction Rev. Number: 02
Process Failure Mode and Effect Analysis Effective date: 02/09/2018
Pages: 9

1. Does the Potential Failure Mode physically prevent downstream processing or cause
potential harm to equipment or operators?
2. What is the potential impact on the End User?
3. What would happen if an effect was detected prior to reaching the End User?

Sev (d): Severity(S) is the value associated with the most serious effect for a given failure mode.
Score all the Potential Effect(s) of Failure based on the table in 8.4.1 section.

Class (e): This column may be used to highlight high priority failure modes or causes that may
require additional engineering assessment. This may also be used to classify any special product or
process characteristics (e.g., critical, key, major, significant) for components, subsystems, or
systems that may require additional process control.

Potential Cause(s) of Failure Mode (f): Potential cause of failure is defined as an indication of how
the failure could occur, and is described in terms of something that can be corrected or can be
controlled. Identify and document every potential cause for each failure mode. This should be
detailed as concisely and completely as possible. Separating the causes will result in a focused
analysis for each and may yield different measurement, controls, and action plans. There may be
one or more causes that can result in the failure mode being analysed.

Occur (g): Occurrence is the likelihood that a specific cause of failure will occur. This likelihood of
occurrence ranking number has a relative meaning rather than an absolute value. Score all the
Potential Cause(s) of Failure Mode based on the table in 8.4.2 section.

Current Process Controls (h): Current Process Controls are descriptions of the controls that can
either prevent to the extent possible, the cause of failure from occurring or detect the failure mode
or cause of failure should it occur. There are two types of Process Controls to consider:

1. Prevention: Eliminate (prevent) the cause of the failure or the failure mode from occurring,
or reduce its rate of occurrence. For example: SPC
2. Detection: Identify (detect) the cause of failure or the failure mode, leading to the
development of associated corrective action(s) or countermeasures. For example:
Dimension measuring

Detect (h): Detection is the rank associated with the best detection control listed in the Controls
column. Detection is a relative ranking within the scope of the individual FMEA. In order to achieve
a lower ranking, generally the planned detection control has to be improved. When more than one
control is identified, it is recommended that the detection ranking of each control be included as part
of the description of the control. Assume the failure has occurred and then assess the capabilities of
all “Current Process Controls” to prevent shipment of the part having this failure mode. Use scoring
based on the table in 8.4.3 section

R.P.N.: Once the team has completed the initial identification of failure modes and effects, causes
and controls, including rankings for severity, occurrence and detection, they must decide if further
efforts are needed to reduce the risk. It is the team’s responsibility to look at the information, decide
upon an approach, and determine how to best prioritize their risk reduction efforts which best serve

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If this is a copy, unless otherwise specified, it is uncontrolled. You must verify the revision before use.
6
 Author: Jasson Zhang Approved by (if required): Jeff Wagner Original released date: 03/31/2017
Function: Global Supplier Quality Valid for – if other than resp. function: Nilfisk Doc. Number: QMS-6-070144
Language: English Document type: Work Instruction Rev. Number: 02
Process Failure Mode and Effect Analysis Effective date: 02/09/2018
Pages: 9

their organization and customers. One approach to assist in action prioritization has been to use the
Risk Priority Number:

RPN = Severity x Occurrence x Detection

This value can range between 1 and 1000.

Recommended actions (k): If the RPN>100, it is need to determine actions to decrease this score.
The intent of any recommended action is to reduce rankings in the following order: severity,
occurrence, and detection.

1. To Reduce Severity Ranking: Only a design or process revision can bring about a reduction
in the severity ranking.
2. To Reduce Occurrence Ranking: Process and design revisions may be required. A
reduction in the occurrence ranking can be effected by removing or controlling one or more
of the causes of the failure mode through a product or process design revision.
3. To Reduce Detection Ranking: The preferred method is the use of error/mistake proofing.
A redesign of the detection methodology may result in a reduction of the detection ranking.
Generally, improving detection controls requires the knowledge and understanding of the
dominant causes of process variation and any special causes. Increasing the frequency of
inspection is usually not an effective action and should only be used as a temporary measure
to collect additional information on the process so that permanent preventive/corrective
action can be implemented.

Responsibility and Target Date (l): Enter the name of the individual and organization responsible
for completing each recommended action including the target completion date. The process-
responsible team leader is responsible for ensuring that all actions recommended have been
implemented or adequately addressed.

Actions Taken (m): After the action has been implemented, enter a brief description of the action
taken.

Sev, Occ, Det, R.P.N. (n): After the preventive/corrective action has been completed, determine
and record the resulting severity, occurrence, and detection rankings. Calculate the record the RPN.
All revised rankings should be reviewed. Actions alone do not guarantee that the problem was solved
(i.e., cause addressed), thus an appropriate analysis or test should be completed as verification. If
further action is considered necessary, repeat the analysis. The focus should always be on
continuous improvement with a priority of highest risk.

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7
 Author: Jasson Zhang Approved by (if required): Jeff Wagner Original released date: 03/31/2017
Function: Global Supplier Quality Valid for – if other than resp. function: Nilfisk Doc. Number: QMS-6-070144
Language: English Document type: Work Instruction Rev. Number: 02
Process Failure Mode and Effect Analysis Effective date: 02/09/2018
Pages: 9

8.4 PFMEA ranking tables

8.4.1 Severity ranking table

Effect of Failure Severity (Customer effect)
Potential failure mode affects safe machine operation without
warning or noncompliance with government regulations
Fails to meet Safety or
Regulatory Requirements Potential failure mode affects safe machine operation with
warning or noncompliance with government regulations
Machine inoperable with severe damages. Does not affect
safety
Machine inoperable. Does not affect safety or machine
operable with direct impacts that could drive Critical
Loss or degradation of
characteristic performance below 3 sigma LT.
Primary Function
Extensive damage to user / customer property
Machine operable but a reduced level of performance or direct
impact that could drive a Critical characteristic performance
below 2 sigma LT.
Light damage to user / customer property
Machine operable but loss or degradation of auxiliary
functions
Secondary Function
Appearance or audible noise that definitely will annoy
customers (more than 75%)
Appearance or audible noise that will annoy heavily most
customers (between 50% and 75% of customers)
Appearance or audible noise, item does not conform and
Annoyance
noticed by many customers (between 25 % and 50%)
Appearance or audible noise, item does not conform and
noticed by discriminating customers (< 25%)
No effect No discernible effect
Severity (Manufacturing-Assembly
Rank Examples
Effect)
Liquid gas reservoir explosion.Unexpected machine start May endanger operador (machine or assembly)
10
moving.Electrical shock to the customer without warning
Brakes malfunction
May endanger opperador (machine or assembly)
9 Inconsistent steering
with warning
Slippery surface
Severe motor and harness overheat that destroys both
100% of product may have to be scrapped, line
8 components without fire. Bad company image and high
shutdown or stop ship.
Warranty cost!
Vac motor does not work. Warranty cost.
a portion of the production run may have to be
Worn / damaged carpet
7 scrapped, deviation from primary process including
Very noticeable scratch on wall / floor
decreased line speed or added man power
Low vacuum level creates poor drying operation.
100% of production run may have to be reworked
6 Warranty cost.
off line and accepted.
Light scratch on wall / floor. Lightly damaged carpet
Total or partial loss of display indicators. Warranty cost.
Rattle loud noise that does not affect machine a portion of the production run may have to be
5
performance but makes very uncomfortable to work with reworked off line and accepted.
the machine
100% of production run may have to be reworked
4 annoying whistling of medium intensity
in station before it is processed.
a portion of the production run may have to be
3 Part of the Decals sticks out after few months
reworked in-station before it is processed.
Slight inconvenience to process, operation or
2 Lost of shine; color not totally constant.
operator.
1 no dicernible effect.

8.4.2 Occurrence ranking table

Occurrence
Likelihood of Occurrence
(incidents per item / % Fail Rate Rank
Failure (Design Life/reliability of item/vehicle)
machines)
Very High New technology/desing with no history 1 in 2 + 50% 10
Failure is inevitable in new design, new application or change in
1 in 3 30% 9
duty cycle or ambient conditions
Failure is likely in new design, new application or change in duty
High 1 in 8 12% 8
cycle or ambient conditions
Failure is uncertain in new design, new application or change in
1 in 20 5% 7
duty cycle or ambient conditions
Frequent failures associated with similar designs or in design
1 in 80 1.25% 6
simulation and testing
Occasional failures associated with similar designs or in design
Moderate 1 in 400 0.25% 5
simulation and testing
Isolated failures associated with similar designs or in design
1 in 2.000 0.05% 4
simulation and testing
Only isolated failures observed associated with almost identical
1 in 10.000 100 ppm 3
design simulation and testing
Low
No failures observed associated with almost identical design
1 in 100.000 10 ppm 2
simulation and testing
Very Low Failure is eliminated through preventive control 1 in 1.000.000 1 ppm 1

COMPANY CONFIDENTIAL
If this is a copy, unless otherwise specified, it is uncontrolled. You must verify the revision before use.
8
 Author: Jasson Zhang Approved by (if required): Jeff Wagner Original released date: 03/31/2017
Function: Global Supplier Quality Valid for – if other than resp. function: Nilfisk Doc. Number: QMS-6-070144
Language: English Document type: Work Instruction Rev. Number: 02
Process Failure Mode and Effect Analysis Effective date: 02/09/2018
Pages: 9

8.4.3 Detection ranking table

Detection
Detection PFMEA Reference Ranking
%
Absolute Uncertainty No current process control; cannot detect or is not analyzed. 10 0
Very Remote failure mode and/or error (cause) is not easily detected. 9 0.01
Failure mode detection post-processing by operator through visual/tactile/audible means. Inspection
Remote 8 0.3
item is not declared in a document (traveler sheet, work instruction)
Failure mode detection in-station by operator through visual/tactile/audible means or post-processing
Very Low through use of attribute gauging (go/no-go, manual torque check/clicker wrench, etc). Inspection item 7 0.7
declared in document (traveler sheet, work instruction)
Failure mode detection post-processing by operator through use of variable gauging or in-station by
Low 6 0.9
operator through use of attribute gauging (go/no-go, manual torque check/clicker wrench, etc).
Failure mode or error (cause) detection in station by operator through use of variable gauging or by
Moderate automated controls in-station that will detect discrepant part and notify operator (light, buzzer, etc.). 5 0.95
Gauging performed on setup and first-piece check (for set-up causes only).
Failure mode detection post-processing by automated controls that will detect discrepant part and
Moderately High 4 0.99
lock part to prevent further processing.
Failure mode detection in-station by automated controls that will detect discrepant part and
High 3 0.999
automatically lock part in station to prevent further processing.
Error (cause) detection in-station by automated controls that will detect error and prevent discrepant
Very High 2 0.9999
part from being made.
Error (cause) prevention as a result of fixture design, machine design or part design. Discrepant parts
Almost Certain 1 0.99999
cannot be made because item has been error-proofed by process/product design.

9.0 RECORDS
 PFMEA format - Nilfisk PPAP forms QMS-2-070058 (or supplier template)

10. REVISION LOG

Section Rev Description Of Change Review Reviewe Approve Approved
. date d by: date by:

All 01 Original Release (Initial Version) 03/13/2017 Laszlo Vilimi 5/19/2017 Jeff Wagner

All 02 GSQE replaced with SQE in document; 01/23/2018 Laszlo Vilimi 02/09/2018 Jeff Wagner
added AIAG standard as reference;
Added detailed information about the
template elements

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