EN 9136:2018

Aerospace series - Root cause analysis and problem solving (9S Methodology)

1.1   General
The objective of any organization, as part of continual improvement, is to reduce the number of issues (i.e. undesirable conditions, defects, failures) and to minimize their impact on quality, delivery performance, and cost.
This includes having processes in place to detect and eradicate significant and recurrent issues, which implies having well identified problems, a common understanding of their impact and associated root causes, and having defined and implemented adequate actions so that these problems, including similar issues will not happen again.
1.2   Purpose
Propose a methodology to improve the way escapes and issues are managed, including communication between all parties [e.g. engineering, Materials Review Board (MRB), manufacturing, manufacturing engineering, supplier, customer] to reduce their impact, contain them as far upstream as possible, and prevent recurrence (i.e. ensure the right measures are taken at the right location and at the right time).

Luft- und Raumfahrt - Ursachenanalyse und Problemlösung (9S-Methodik)

1.1 Allgemeines
Im Rahmen der kontinuierlichen Verbesserung ist es das Ziel jeder Organisation, die Anzahl von Problemen (d. h. unerwünschte Zustände, Defekte, Ausfälle) zu verringern und ihre Auswirkungen auf die Qualität, erbrachte Leistung und die Kosten zu minimieren.
Dies beinhaltet auch verfügbare Prozesse zur Erkennung und Beseitigung erheblicher oder wiederholt auftretender Probleme, was eine präzise Identifikation von Problemen, ein gemeinsames Verständnis ihrer Auswirkungen und der entsprechenden Grundursachen sowie die Definition und Implementierung geeig¬neter Maßnahmen zur Vorbeugung gegen ein erneutes Auftreten dieser und ähnlicher Probleme erfordert.
1.2 Zweck
Vorstellung einer Methode zur Verbesserung der Handhabung von Abweichungen und Problemen, ein-schlie߬lich Kommunikation zwischen allen Beteiligten [z. B. Konstruktion, Materials Review Board (MRB), Produktion, Produktionstechnik, externer Anbieter, Kunde], um deren Auswirkungen zu verringern, sie so früh wie möglich zu korrigieren und ein wiederholtes Auftreten zu verhindern (d. h. sicherzustellen, dass die richti¬gen Maßnahmen am richtigen Ort zur richtigen Zeit ergriffen werden).

Série aérospatiale - Analyse de cause racine et résolution de problème (9S méthodologie)

1.1   Généralités
L'objectif de toute organisation, dans le cadre d'une amélioration continue, consiste à réduire le nombre des problèmes (notamment les états de fonctionnement indésirables, les défauts, les pannes), et à minimiser leur impact sur la qualité, les performances et les coûts.
Cela implique d'avoir des procédures en place pour détecter et éradiquer les problèmes importants et récurrents, et donc de bien identifier les problèmes, bien comprendre leur impact et leurs causes fondamentales, et de disposer d'actions adéquates clairement définies et établies afin que ces problèmes et tout défaut similaire ne se reproduisent pas.
1.2   Objectif
Proposer une méthodologie qui améliore la gestion des fuites et défauts, y compris par la communication entre toutes les parties concernées (soit les ingénieurs, le Materials Review Board (MRB), le fabricant, l'ingénieur de fabrication, le fournisseur, le client) afin de réduire leur impact, de limiter leurs répercussions sur les derniers échelons de la chaîne de production, et d'en empêcher la récurrence (soit garantir que les mesures idoines soient prises au bon endroit et au bon moment).

Aeronavtika - Analiza izvornih vzrokov in reševanje težav (metodologija 9S)

V okviru nenehnega izboljševanja si vse organizacije prizadevajo zmanjšati število težav (tj. neželenih pogojev, napak, okvar) in čim bolj zmanjšati njihov vpliv na kakovost, izvedbo dostave in stroške.
To vključuje tudi vzpostavitev postopkov za zaznavanje in odpravljanje večjih in ponavljajočih se težav, kar pomeni, da je treba natančno opredeliti probleme, poskrbeti za splošno razumevanje njihovega vpliva in povezanih izvornih vzrokov ter opredeliti in izvajati ustrezne ukrepe, da se takšne in podobne težave ne bodo ponovile.
Predlagati je treba metodologijo za upravljanje odstopanj in težav, vključno s komunikacijo med vsemi strankami [npr. inženiring, Odbor za pregled materialov (MRB), proizvodnja, proizvodni inženiring, dobavitelj, odjemalec], da se njihov vpliv zmanjša in čim prej zajezi ter se prepreči njihovo ponovitev (tj. poskrbi za pravilne ukrepe na pravi lokaciji in ob pravem času).

General Information

• Status: Published
• Publication Date: 30-Aug-2018
• Withdrawal Date: 29-Nov-2018
• ICS: 03.120.10 - Quality management and quality assurance
• ICS: 49.020 - Aircraft and space vehicles in general
• Technical Committee: ASD-STAN - Aerospace
• Drafting Committee: ASD-STAN/D 6/S 1 - EAQG European Aerospace Quality Group
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 16-May-2018
• Completion Date: 16-May-2018
• Ref Project: SIST EN 9136:2018 - Aerospace series - Root cause analysis and problem solving (9S Methodology)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 9136:2018
01-julij-2018
Aeronavtika - Analiza izvornih vzrokov in reševanje težav (metodologija 9S)
Aerospace series - Root cause analysis and problem solving (9S Methodology)
Luft- und Raumfahrt - Ursachenanalyse und Problemlösung (9S Methodik)
Série aérospatiale - Analyse de cause racine et résolution de problème (9S
méthodologie)
Ta slovenski standard je istoveten z: EN 9136:2018
ICS:
03.120.01 Kakovost na splošno Quality in general
49.020 Letala in vesoljska vozila na Aircraft and space vehicles in
splošno general
SIST EN 9136:2018 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 9136:2018
---------------------- Page: 2 ----------------------
SIST EN 9136:2018
EN 9136
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2018
EUROPÄISCHE NORM
ICS 03.120.10; 49.020
English Version
Aerospace series - Root cause analysis and problem
solving (9S Methodology)

Série aérospatiale - Analyse de cause racine et Luft- und Raumfahrt - Ursachenanalyse und

résolution de problème (9S méthodologie) Problemlösung (9S Methodik)
This European Standard was approved by CEN on 20 November 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9136:2018 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN 9136:2018
EN 9136:2018 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

Rationale ........................................................................................................................................................................... 4

Foreword .......................................................................................................................................................................... 4

Introduction .................................................................................................................................................................... 5

1 Scope .................................................................................................................................................................... 6

1.1 General ................................................................................................................................................................ 6

1.2 Purpose ............................................................................................................................................................... 6

2 Normative references .................................................................................................................................... 6

3 Terms and definitions ................................................................................................................................... 6

4 General Process ............................................................................................................................................... 9

4.1 Basic Principles ................................................................................................................................................ 9

4.1.1 Cultural Change ................................................................................................................................................ 9

4.1.2 Effective Communication .......................................................................................................................... 10

4.2 When to Apply a Structured Root Cause Analysis and Problem Solving Process ................. 10

4.3 Process Step Description ........................................................................................................................... 12

5 Process Steps ................................................................................................................................................. 14

5.1 Step 0 – Start Immediate Containment Actions ................................................................................. 14

5.2 Step 1 – Build the Team .............................................................................................................................. 16

5.3 Step 2 – Define Problem ............................................................................................................................. 18

5.4 Step 3 – Complete and Optimize Containment Actions .................................................................. 20

5.5 Step 4 – Identify Root Cause(s) ................................................................................................................ 21

5.6 Step 5 – Define and Select Permanent Corrective Actions ............................................................ 23

5.7 Step 6 – Implement Permanent Corrective Action and Check Effectiveness .......................... 24

5.8 Step 7 – Standardize and Transfer the Knowledge Across Business ......................................... 26

5.9 Step 8 – Recognize and Close the Team ................................................................................................ 27

6 Information and documentation ............................................................................................................ 29

6.1 Information data definition and documentation.............................................................................. 29

6.2 Forms ................................................................................................................................................................ 30

6.3 Control of records ........................................................................................................................................ 30

(informative) Acronym log ..................................................................................................................... 31

(informative) Information data definition ....................................................................................... 32

(informative) Form examples ................................................................................................................ 48

---------------------- Page: 4 ----------------------
SIST EN 9136:2018
EN 9136:2018 (E)
European foreword

This document (EN 9136:2018) has been prepared by the Aerospace and Defence Industries

Association of Europe - Standardization (ASD-STAN).

After enquiries and votes carried out in accordance with the rules of this Association, this Standard has

received the approval of the National Associations and the Official Services of the member countries of

ASD, prior to its presentation to CEN.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by November 2018, and conflicting national standards

shall be withdrawn at the latest by November 2018.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent

rights.

According to the CEN-CENELEC Internal Regulations, the national standards organisations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
---------------------- Page: 5 ----------------------
SIST EN 9136:2018
EN 9136:2018 (E)
Rationale

The objective of root cause analysis and problem solving is to not only reduce the number of issues

(i.e. undesirable conditions, defects, failures), but to minimize their impact on quality, delivery

performance, costs, and ultimately on the customer. Often big issues originate with small problems that

were discovered too late or were discovered, but were never resolved due to a lack of understanding

the actual issue(s), incorrect analysis of the root cause, and/or ineffective actions being taken.

This guidance document was created to provide a methodology for performing root cause analysis to

resolve a significant or recurrent issue [e.g. quality, On-Time Delivery (OTD), process, documentation),

as guidance within the aviation, space, and defence industry and/or when contractually invoked at any

level of the supply chain.
Foreword

In December 1998, the aviation, space, and defence industry established the International Aerospace

Quality Group (IAQG) with the purpose of achieving significant improvements in quality and reductions

in cost throughout the value stream. This organization, with representation from aviation, space, and

defence companies in the Americas, Asia-Pacific, and Europe and sponsored by SAE International,

Society of Japanese Aerospace Companies (SJAC), and AeroSpace and Defence Industries Association of

Europe -Standardization (ASD-STAN), has agreed to take responsibility for the technical content of this

document to promote best practices that would satisfy associated requirements of Aerospace Quality

Management System (AQMS) standards (i.e. 9100, 9110, 9120).

To assure customer satisfaction, aviation, space, and defence industry organizations must produce and

continually improve safe, reliable products that meet or exceed customer and regulatory authority

requirements. This includes having processes in place to detect and eradicate significant and recurrent

issues. This document standardizes methodology to perform root cause analysis and problem solving to

support these efforts. The establishment of a common methodology, for use by organizations at all

levels of the supply-chain should result in improved action plans and a standardized way of exchanging

information between organizations and external stakeholders (e.g. suppliers, partners, customers,

regulatory agencies).
---------------------- Page: 6 ----------------------
SIST EN 9136:2018
EN 9136:2018 (E)
Introduction

This document has been developed by the IAQG. In accordance with the continual improvement

requirements defined in the 9100-series standards (see Clause 8, “Measurement, Analysis, and

Improvement”), it was deemed useful to promote those industry recognized best practices for

identifying the root causes of nonconformities or undesirable conditions (including potential issues and

conditions) and implementing correction(s) and associated corrective/preventive actions. The process

described in this document was created by comparing and mixing root cause analysis and problem

solving methodologies [e.g. 7 Steps, 8D, Root Cause Corrective Action (RCCA)] used by main actors of

aviation, space, and defence industry.

Unless contractually specified, other root cause analysis processes with slightly different sequencing of

activities and/or different names of process steps may be acceptable, provided that these activities

meet the intent of this document and deliver the same outcomes (i.e. immediate protection, temporary

fix, durable solution, systemic improvement) and provides the same level of information.

Throughout this document, the words “should” and “required” indicate strong recommendations to

apply and correspond to actions that the authors of this document consider important in order to

deliver robust root cause analysis. When strict application of this document is decided by an

organization or is mandated by a customer, they shall be interpreted as an obligation to be complied

with (i.e. interpreted as “shall” and “must”).
---------------------- Page: 7 ----------------------
SIST EN 9136:2018
EN 9136:2018 (E)
1 Scope
1.1 General

The objective of any organization, as part of continual improvement, is to reduce the number of issues

(i.e. undesirable conditions, defects, failures) and to minimize their impact on quality, delivery

performance, and cost.

This includes having processes in place to detect and eradicate significant and recurrent issues, which

implies having well identified problems, a common understanding of their impact and associated root

causes, and having defined and implemented adequate actions so that these problems, including similar

issues will not happen again.
1.2 Purpose

Propose a methodology to improve the way escapes and issues are managed, including communication

between all parties [e.g. engineering, Materials Review Board (MRB), manufacturing, manufacturing

engineering, supplier, customer] to reduce their impact, contain them as far upstream as possible, and

prevent recurrence (i.e. ensure the right measures are taken at the right location and at the right time).

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

EN 9100, Quality Management Systems — Requirements for Aviation, Space and Defence Organizations

EN 9110, Quality Management Systems — Requirements for Aviation Maintenance Organizations

EN 9120, Quality Management Systems — Requirements for Aviation, Space and Defence Distributors

EN ISO 9000:2015, Quality management systems — Fundamentals and vocabulary (ISO 9000:2015)

3 Terms and definitions

Definitions for general terms can be found in EN ISO 9000 and the IAQG Dictionary, which is located on

the IAQG website. An acronym log for this document is presented in Annex A.
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
apparent cause
(also referred to as obvious cause, direct cause, or immediate cause)
event or action that immediately results in or precedes the nonconformity
Note 1 to entry: This is generally NOT the root cause.
---------------------- Page: 8 ----------------------
SIST EN 9136:2018
EN 9136:2018 (E)
3.2
containment

action to control and mitigate the impact of a problem and protect the organization and/or customer

(i.e. stop the problem from getting worse), includes correction, immediate corrective action, immediate

communication, and verification that problem does not further degrade
3.3
contributing causes

causes that by themselves would not cause the problem, but can increase the risk of the issue to occur.

Analysis for these causes generally requires taking a closer look at the existing conditions and

associated actions
3.4
correction
(also referred to as Immediate Correction)
action taken to eliminate a detected nonconformity
[SOURCE: EN ISO 9000:2005, 3.6.6, modified]

Note 1 to entry: A correction can be made in conjunction with a corrective action.

Note 2 to entry: For product nonconformity, correction might be understood as reworking the part, accepting

the nonconformance through concession process, or scrapping the product.

Note 3 to entry: For a system issue, it may include correcting the paper work or issuing a new purchase order.

Note 4 to entry: For a delivery issue, it may include revising to air transportation instead of delivering product

by truck or ship, increasing production rate, etc.
3.5
corrective action

action taken to eliminate the cause of a detected nonconformity or other undesirable situation to

prevent recurrence
[SOURCE: EN ISO 9000:2005, 3.6.5, modified]

Note 1 to entry: A correction can be made in conjunction with a corrective action.

Note 2 to entry: Corrective action may address all types of causes (i.e. apparent, contributing, root causes).

3.6
immediate corrective action

action taken to eliminate, prevent, or reduce the probability of any additional nonconformances related

to the apparent cause from happening again in the short term

Note 1 to entry: These actions may be temporary and should remain in place until the root cause(s) is identified

and permanent RCCA is implemented and verified to be effective.
---------------------- Page: 9 ----------------------
SIST EN 9136:2018
EN 9136:2018 (E)
3.7
nonconformity
non-fulfilment of a requirement
[SOURCE: EN ISO 9000:2005, 3.6.2]

Note 1 to entry: It may be a nonconforming product, but may also be a late delivery, incorrect paperwork,

incorrect process [production or Quality Management System (QMS) related], etc.
3.8
preventive action

action to eliminate the cause of a potential nonconformity or other undesirable potential situation

[SOURCE: EN ISO 9000:2005, 3.6.4, modified]

Note 1 to entry: Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent

recurrence.
3.9
root cause

original event(s), action(s), and/or condition(s) generating (directly or in cascade) an actual or

potential undesirable condition, situation, nonconformity, or failure

Note 1 to entry: There is sometimes more than one root cause associated to a single nonconformity or one root

cause with multiple contributing causes.
3.10
root cause analysis

process of identifying all the causes (root cause and contributing causes) that have or may have

generated an undesirable condition, situation, nonconformity, or failure
3.11
Root Cause Corrective Action
RCCA
(also referred to as Permanent Corrective Action)

action implemented to address the root cause(s) and contributing cause(s) of the undesirable condition,

situation, nonconformity, or failure; action taken to prevent recurrence
3.12
Root Cause Corrective Action (RCCA) Effectiveness Verification

action taken to verify that the planned corrective action(s) have prevented recurrence of the identified

root cause or contributing causes, and have consequently eradicated the problem

Note 1 to entry: This may include auditing, monitoring of specific metrics, or any other reporting

methodologies.
3.13
Root Cause Corrective Action (RCCA) Implementation Verification
action taken to verify that the planned actions were taken as scheduled

Note 1 to entry: This includes specific actions, milestones, completion dates, and responsibilities.

---------------------- Page: 10 ----------------------
SIST EN 9136:2018
EN 9136:2018 (E)
4 General Process
4.1 Basic Principles

a) In many instances, organizations and their suppliers do not provide adequate root cause analysis

and problem solving results because:

— no clear criterion exists for an acceptable corrective action plan; organizations are satisfied

when they no longer receive defective parts;

— the organization continues to accept inadequate corrective action plans as priority is given to

schedule versus quality;

— organizations (internal/external) do not have a root cause analysis mind set; people don’t

know or understand the process and/or have not been effectively trained.

b) A robust root cause analysis and problem solving process should provide visibility of the following

information:

— how the issue is managed and communicated between all stakeholders (e.g. engineering, MRB,

suppliers, customer);
— how it is ensured that the actual root cause(s) has been identified;

— how it is ensured that the right measures are taken at the right location, at the right time, and

by the right individuals;

— how containment actions taken to protect the customer and production efforts are identified

and managed.
c) Problem solving approaches can be summarized as:

— Reactive Mode – solving the abnormality that has occurred; gathering and analysing data aims

to provide customer protection and associated countermeasures;

— Proactive Mode – analysing failures and looking for product, process, or system improvements;

— Preventive Mode – putting in place solutions before an undesirable condition, defect, or failure

occurs.
4.1.1 Cultural Change

Cultural change is generally required to progress from a “reactive” mode to “proactive” and/or

“preventive” modes.
a) Examples of traditional behaviours:
— quick fix;
— not taking adequate time for analysis;
— going from one crisis to another;
— looking for the guilty party – “Who did that?”
---------------------- Page: 11 ----------------------
SIST EN 9136:2018
EN 9136:2018 (E)
— blaming or transferring responsibility;
— generate laundry list of solutions to firefight the symptoms;
— narrow focus taken to address the immediate problem;

— focus on performance metrics/measures (e.g. sales, profits) with hope that processes will

improve by themselves.
b) Expected “systems thinking” behaviour to get “systemic solutions”:
— understanding that many factors contribute to a complex situation;

— fully understanding the actual problem and then addressing the systemic root cause(s);

— permanently fixing and improving performance;
— seeking total understanding of the process – “How did that happen?”

— taking time to understand the big picture; to dialogue and elicit diverse perspectives before

applying the solution;
— focusing on improving processes; actually effecting process performance.
4.1.2 Effective Communication

The behaviour of all process performers and stakeholders are key factors of success in the application

of a robust root cause analysis and problem solving process.
Effective communication is mandatory:

— Within the organization where the problem originated, and between process performers and

stakeholders of the supply chain to ensure effective root cause analysis and corrective action

implementation.

— Between supplier and customer to immediately stop the problem from getting worse, ensure full

understanding of the problem, and verify that implemented solutions are satisfactory.

NOTE The conditions where the customer must be notified should be established and documented. If the

conditions cannot be specified with tangible trigger points, then direction should be given for how to evaluate

each situation to ensure the customer is kept informed, as appropriate.
4.2 When to Apply a Structured Root Cause Analysis and Problem Solving Process

Launching a formal root cause analysis and problem solving process should always be considered, when

an issue (undesirable conditions, defects, and failures) is detected and the cause is unknown or

inconclusive (not obvious). The decision to apply or not apply the process should be made at the

appropriate level of management within the company based on the level of risk and whether the risk

associated is acceptable or not, using a rational decision making process and maintaining records of

significant decisions.
The process should always be applied, if one or more of these conditions exist:
— safety impact (product/personal);
---------------------- Page: 12 ----------------------
SIST EN 9136:2018
EN 9136:2018 (E)
— product strength, performance, and/or reliability issue;
— high impact on production/maintenance operations:

— stop the production/maintenance line; prevent next operation to occur satisfactorily, etc;

— regulatory authorities and/or customer dissatisfaction;
— costs issue (generated to the customer or the organization);
— disruption of supplier’s process or customer's operations.
— repetitive problems to one part or similar activities/processes;
— difficulty to detect;
— customer request;
— significant quality or QMS issue;

— complex problem that cannot be solved without assistance of other people than those located

where the problem occurred.

Generally speaking, the impact of an issue and the frequency of its occurrence should always be

considered when deciding to launch or not launch a formal root cause analysis (see Figure 1).

---------------------- Page: 13 ----------------------
SIST EN 9136:2018
EN 9136:2018 (E)
Key
1 Not required
2 Optional
3 Recommended
4 Mandatory
5 Customer request shall always take precedence
X Frequency
Y Impact

Figure 1 — Applying a structured root cause analysis and problem solving process depending on

the impact and frequency of a problem
4.3 Process Step Description
The process is described in nine steps by S0 to S8 (see Figure 2).
---------------------- Page: 14 ----------------------
SIST EN 9136:2018
EN 9136:2018 (E)
Figure 2 — Root cause analysis general process mapping

The criticality of the problem should be determined, based on evaluation of the risk(s) it generates,

taking into consideration the following elements: the severity of the issue (i.e. its impact on the

business, the product, and/or the customer) its detectability, its probability to occur, etc.

This document defines the elements for each of the nine process steps:
a) objective(s) of the step;
b) output(s) of the step;
c) what are the associated actions for this step;
d) why this step is necessary and the potential risk if no action is taken;
e) when does the activity take place;
f) who are the principle process performers and applicable stakeholders;

g) how to manage this process step so that it is effective, including providing some proposed tools to

be used;
h) communication aspects to take into consideration;
i) specific Items to be considered.
---------------------- Page: 15 ----------------------
SIST EN 9136:2018
EN 9136:2018 (E)
5 Process Steps
5.1 Step 0 – Start Immediate Containment Actions

a) Objective: To mitigate the impact of the problem, to protect customer operations and the

organization (i.e. stop the problem from getting worse), and verify that the situation does not

deteriorate until the root cause and contributing causes are known.

b) Output: Immediate containment actions defined and implemented; customer protected.

c) What: Actions required to protect the customer and the organization from negative impacts

associated to the problem.

d) Why: If the problem that has been identified is having an impact on the customer or organization,

the situation will continue to deteriorate, especially if no action is taken. This justifies a

development and deployment of a containment plan.

e) When: As soon as the problem is detected and perceived impact on customer or organization

operations is suspected.

NOTE For most critical cases and/or to be in line with customer/regulatory requirements, immediate

containment action may be required within one business working day of detection or less.

f) Who: Should be assigned to an individual or organization, as appropriate.

g) How: Launch immediate preliminary analysis to understand the problem and its immediate impact;

ensuring adequate focus on the effects of the problem, not its cause(s).
Depending on the results of this analysis:

— identify and isolate defective parts or data, and perform immediate containment and/or

correction, as required;

— identify apparent cause and perform immediate corrective action to eliminate, prevent, or

reduce the probability of any additional nonconformances from happening and/or escaping in

the short term.
Typical immediate containment actions may include:
— immediate suspension of Work-in-Progress (WIP);
— stop deliveries;
— recall product (still within the organization or already delivered);

— strengthen associated quality assurance/inspection processes (i.e. inspections, checks, tests);

“Build the wall higher”;
— conduct inventory checks and segregate defective parts;

— temporary update and/or reinforcement of processes, instructions, activities, and documents;

particularly in the case of QMS deficiencies.
Identify immediate/potential risk for affected parts if not detected.
---------------------- Page: 16 ----------------------
SIST EN 9136:2018
EN 9136:2018 (E)

Determine criticality based on the facts and information available at this time (may evolve at future

steps once there is a better understanding of the problem and associated conditions):

— Can the team assess criticality?

— If not, who should be contacted (e.g. customer, design office, type certificate ho

...