API Specification Q1 9th Edition Training

Welcome to the Training!

Trainer Name:

Teevakaren Battumalai <Teeva>

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 Safety First!

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 We need
a
Break!

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Please silence your cell phones
and close your computers.
E-mails can be checked during the break!

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What will you learn?
What is API Specification Q1 9th Edition all about?

What are the goal, scope and applicability of API Specification Q1 9th
Edition?

What are the benefits of API Specification Q1 9th Edition?

What are the key changes from the 8th Edition?

What is the transition plan?

What are the key requirements, and structure of API Specification Q1 9 th

Edition?

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5,
issue
How this course is built up

Introduction
Group activities

Brainstorming
Terminology and Concepts

Theoretical input

Key Changes and

Requirements Reflection

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 How to Contribute Today

Illustration coming Illustration coming

Learning new things is demanding, but fun Active participation

Illustration coming Illustration coming

There are no stupid questions Benefit from sharing experiences

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 INTRODUCTION

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Scope
Specification for QMS requirements for Manufacturing
Organizations for the Petroleum and Natural Gas Industry:
Manufacturer of products,
Manufacturing-related services under a product
specification (Heat Treatment, Threading &
Testing)

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 Scope Exclusion

Limited to:
 5.4 Design and Development
 5.7.1.2 Servicing
 5.7.1.5 Validation of Processes for Production and Servicing
 5.7.5 Customer-supplied Property
 5.8 Control of Testing, Measuring, and Monitoring
Equipment

 Basis for claiming exclusions is to be identified!

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Group Discussion….
Scope Exclusion

Discuss in your group and determine the clauses

that can be excluded in your company’s QMS
What are the justifications?
Present your work to the class

 15 mins

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 Overview

 Represents a major change and shift in quality management

for oil and gas equipment manufacturers
 Introduces over 85 new clauses and 5 entirely new sections
including
– Risk Assessment and Management
– Contingency Planning
– Product Quality Plan
– Preventive Maintenance
– Management of Change

 All API Spec Q1 systems must be in compliance by June-2014

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 Key API Spec Q1 9th Edition
Transition Highlights
 June through November 2013
– API will conduct audits to API Spec Q1 8th edition.
 December 2013 through May 2014
– API will conduct all audits to the API Spec Q1 9th Edition. Findings during
this time will be categorized as "concerns" with no additional follow-up
required.
 March 2014
– Organizations applying for API Spec Q1 9th Edition will be issued
nonconformities based upon API Spec Q1 9th Edition requirements.
 June 2014
– All API Monogram Licenses and API Spec Q1 registered organizations must
conform to API Spec Q1 9th Edition requirements.
 June 2014
– All API Spec Q1 registered organizations must complete a "conformance
matrix" and sign a declaration of conformance and submit both to API by
June 1, 2014.
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 Highlights of API Spec Q1
9th Edition
 No longer follows ISO 9001:2008 structure, but meets ISO 9001
requirements
 Term "Control Feature" no longer used
 27 Required Documented Procedures
 More Control over Outsourced Processes
 Risk Assessment and Management
 Contingency Planning
 Determine Supplier Criticality
 Product Quality Plans
 Designated Storage Areas for Material and Product
 Physical condition of Warehoused Parts and Material
 Preventive Maintenance Plan for Manufacturing Equipment
 Management of Changes (MOC)
 Internal Audits include Outsourced Activities

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 Goal of API SPEC Q1 9th Edition

Continual improvement

Emphasize defect prevention

Minimize variation and waste

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 Benefits of API Spec Q1 9th Edition
standard

 Used by internal or external parties to

assess ability to meet requirements
 Structured in a way to minimize the
likelihood of nonconformity
 Promotes reliability in the manufacturing
sector of petroleum and natural gas industry
 Promotes the integration of a Process
Approach

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 Benefits of API Spec Q1 9th Edition
Certification
 Meet oil and gas industry and customer
demands for API certified or licensed
products
 Increase revenues and overcome your
competitors
 Increased product credibility due to API
Spec Q1 certification and monogram license
 Improve operations and reduce risks within
your organization

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 API Spec Q1 Structure
General
Section 1 Scope Exclusion

Section 2 Normative references Latest edition of referenced document apply (ISO 9000)

ISO 9000 applies

Section 3 Terms, Definitions, and Abbreviations
Definitions in Q1 apply for identical terms

4. Quality Management System

Section 4-6 Requirements 5. Product Realization
6. Monitoring, Measurement, Analysis, Improvement

Annex A Use of API Monogram by Licencees

Annex B Cross-reference from API Q1 9 th Ed to API Q1 8th Ed

Annex C Cross-reference from API Q1 8th Ed to API Q1 9th Ed

Bibliography

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 Overview of the API Monogram
Program
 API Monogram is a registered
certification mark owned by API
 Authorized for licensing by API Board
of Directors
 Applied to products manufactured
under QMS that meets API Q1
 Licenses issued only after on-site
audit verified that QMS meets API
Q1 and product satisfy applicable
API product specification

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 TERMINOLOGY AND CONCEPTS

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 Management System

Management System – system to establish policy and objectives

and to achieve those objectives
ISO 9000, 3.2.2

Quality Management System - management system to direct

and control an organisation with regard to quality
ISO 9000, 3.2.3

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 Policy & Objectives

Quality Policy – overall intentions and directions of an

organisation related to quality as formally expressed by top
management
ISO 9000, 3.2.4

Quality Objectives – something sought, or aimed for, related to

quality
ISO 9000, 3.2.3

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Process

An activity that transforms inputs into outputs

What are the factors that can affect

the successful performance of
an activity?

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Process
People

Materials

Output
Methods

Monitor and
Equipment Measure
Effectiveness

Environment
Apply
changes /
corrections
Inputs
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Procedure

Specified way to carry out an activity or a process

ISO 9000, 3.4.5

Organization’s documented method for performing an activity under

controlled conditions to achieve conformity to specified requirements
API Q1, 3.1.18

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 Corrective & Preventive Action
Correction
Action to eliminate a detected nonconformity

ISO 9000

Corrective Action
Action to eliminate the cause of a detected nonconformity or other
undesirable situation
ISO 9000

Preventive Action
Action to eliminate the cause of a potential nonconformity or other
undesirable potential situation
ISO 9000

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 Conformity

Conformity
Fulfilment of a requirement

ISO 9000

Nonconformity
Non-fulfilment of a requirement
ISO 9000

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 DAC and MAC

Design Acceptance Criteria

Defined limits placed on characteristics of materials, products, or
services established by the organization, customer, and/or applicable
specifications to achieve conformity to the product design

API Q1, 3.1.8

Manufacturing Acceptance Criteria

Defined limits placed on characteristics of materials, products, and
services established by the organization to achieve conformity to the
manufacturing or service requirements

API Q1, 3.1.15

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Group Discussion….
DAC and MAC

Discuss in your groups and provide examples of

DAC and MAC in your company
Present your work to the class

 10 mins

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Other Terms and Definitions
 Acceptance Criteria
Specified limits of acceptability applied to process or product
characteristics.

API Q1, 3.1.1

 Acceptance Inspection
Demonstration through monitoring or measurement that the product
conforms to specified requirements

API Q1, 3.1.2

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Other Terms and Definitions
 Critical
That deemed by the organization, product specification, or customer as
mandatory, indispensable or essential, needed for a stated purpose or
task, and requiring specific action
API Q1, 3.1.6

 First Article
Representative sample of a product, component, or output from a process
used to verify that prescribed activities have satisfied the requirements as
specified by the organization
API Q1, 3.1.11

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Other Terms and Definitions
 Outsource
Function or process that is performed by an external supplier on behalf of
the organization

API Q1, 3.1.16

 Preventive Maintenance
Planned action to minimize the likelihood of equipment failure and
unscheduled interruptions

API Q1, 3.1.17

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Other Terms and Definitions
 Risk
Situation or circumstance that has both a likelihood of occurring and a
potentially negative consequence
API Q1, 3.1.19

 Service
Performance of an activity by one function or organization for another

API Q1, 3.1.20

 Servicing
Product maintenance, adjustment, repair, and/or on-site installation when
installation is required by applicable product specifications
API Q1, 3.1.21

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 KEY CHANGES AND REQUIREMENTS

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 4.1.5 Communication

4.1.5.1 Internal
Internal communication process ensure that:
b) Results of data analysis communicated at
relevant functions and levels

Group discussion:
1. What data needs to be collected and analyzed?
2. How the output of these analysis be communicated?
3. Who it should be communicated to?
15 mins

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 4.1.5 Communication

4.1.5.2 External
External communication process address:
d) Providing information required by product
quality plans and subsequent changes to
plans (when required by contract)

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 4.2.3 Management Representative

MR has responsibility and authority that

includes:
c) Ensuring initiation of actions to minimize
the likelihood of the occurrence of
nonconformities

Group discussion:
1. What are the other responsibilities of the QMR?
5 mins

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 4.3.2 Human Resources

4.3.2.2 Personnel Competence

Evidence for personnel competence
determination recorded and maintained

Group discussion:
1. Establish the key steps in personnel competence and
training process?
15 mins

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 4.3.2 Human Resources

4.3.2.3 Training and Awareness

b) Ensure that customer-specified training
and/or customer-provided training (when
required) is included in training program

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 4.4 Documentation Requirements

4.4.1 General
QMS documentation include:
b) A quality Manual that includes:
3) Identification of processes that
require validation
e) Identification of legal and other applicable
requirements

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 4.4.2 Procedure

All procedures referenced within API Spec Q1

are established, documented, implemented
and maintained

NOTE 1
A single document can address requirements of one or more
procedures.

NOTE 2
A requirement for documented procedures can be satisfied by
more than one document.

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 4.4.3 Control of Documents

Procedures, work instructions and forms

required by QMS are controlled

4.5 Control of Records

Records including those from outsourced

activities are established and controlled to
provide evidence of conformity

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 5.2 Planning

Planning of product realization shall

address:
c) Legal and other applicable requirements
d) Contingencies based on risk assessment
g) Management of change (MOC)

Planning output shall be updated as

changes occur

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 5.3 Risk Assessment

Maintain documented procedure

Identify and control risk associated with
impact on product quality and delivery
Identify techniques, tools and their
application for risk identification,
assessment and mitigation
Risk associated with product delivery
Risk associated with product quality
Maintain records
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 5.3 Risk Assessment
Risk assessment associated with product delivery
include
a)Facility/equipment availability and maintenance
b)Supplier performance and material availability/
supply

Risk assessment associated with product quality

include
a)Delivery of nonconforming product
b)Availability of competent personnel

Records maintained
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 5.3 Risk Assessment

The output of risk assessment may be used

in the development of contingency plans

Risk assessment can be an activity

associated with corrective and/or
preventive action

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Risk Register
Mitigation
Area/
Current Risk Risk
Activity/ Risk Impact S O RPN
Controls level
Process Action PIC Date

S - Severity O – Occurrence RPN – Risk Priority Number RPN = S x O

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Risk Identification and Assessment
- Sample
Current Risk Controls Mitigation
Area/
Risk
Activity/ Risk Impact S O RPN
Prevention Detection level Action PIC Date
Process

Suppliers Cannot • Disruption to 4 • New Supplier • Ongoing 2 8 M Supplier XX XX-

deliver production Assessment supplier Audit XX
raw • Cannot based on performance program
material deliver to established monitoring
customer criteria and
assessment
Quality • Disruption to
issues production
Financial • Disruption to
trouble production
• Cannot
delivery to
customer

S - Severity O – Occurrence RPN – Risk Priority Number RPN = S x O

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 Risk Assessment Criteria –
Severity Rating

SEVERITY (S) EXAMPLE RATING

Catastrophic Customer operation shutdown 5

Major Disruption Customer operation temporarily stopped 4

Moderate Disruption to customer operation but no stoppage 3

Disruption
Minor Disruption Slight inconvenience to customer operation 2

No effect No discernible effect 1

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 Risk Assessment Criteria –
Occurrence Rating

OCCURRENCE
EXAMPLE RATING
(Likelihood)

Most Likely The most likely result of the risk being realized 5

Possible Has a good chance of occurring and is not unusual 4

Conceivable Might occur at sometime in future 3

Remote Has not been known to occur after many years 2

Inconceivable Is practically impossible and has never occurred 1

Probability of Occurrence = Likelihood

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 Risk Assessment Criteria –
Risk Matrix
OCCURRENCE SEVERITY (S)
(Likelyhood) 1 2 3 4 5

5 5 10 15 20 25
4 4 8 12 16 20
3 3 6 9 12 15
2 2 4 6 8 10
1 1 2 3 4 5

High
Medium

Low

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 Mitigation / Risk Control Criteria

RPN DECRIPTION ACTION

15-25 HIGH A HIGH RPN requires immediate action to control
risk to customer. Actions taken must be
documented on the risk assessment form including
date for completion.
5-12 MEDIUM A MEDIUM RPN requires a planned approach to
control risk to customer and apply temporary
measure if required. Actions taken must be
documented on the risk assessment form including
date for completion.
1-4 LOW A LOW RPN may be considered as acceptable and
further reduction may not be necessary. However,
if the risk cannot be resolved quickly and
efficiently, control measures should be
implemented.

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Workshop….
Risk Assessment and Management
Brainstorm in your groups to identify risks
associated with the activity or process assigned
Assess the identified risks based on impact to
product quality and delivery
Determine risk mitigation and controls based on the
assessment results
Present your work to the class

45 mins

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 5.4 Design and Development

5.4.1 Design and Development Planning

Design and development activities
performed at different locations within
organization, procedure shall identify
controls required

5.4.2 Design and Development Inputs

Input include the following as applicable:
g) Results from risk assessments
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Group Discussion….
Design and Development

Discuss in your groups on how risk assessment

results can be used as input for design and
development
Present your work to the class

 15 mins

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 5.4 Design and Development

5.4.3 Design and Development Outputs

Outputs include identification of, or
reference to, products and/or components
deemed critical to the design

5.4.6 Design and Development Validation

and Approval
Completed design approved after validation

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 5.5 Contingency Planning

5.5.1 General
Maintain Documented procedure
Address risk associated with impact on
product quality and delivery
Based on assessed risks
 Output documented and communicated to
relevant personnel
Updated

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 5.5 Contingency Planning
5.5.2 Planning Output
At minimum include
a) Actions required in response to significant
risk scenarios to mitigate effects of
disruptive incidents
b) Identification and assignment of
responsibilities and authorities
c) Internal and external communication
controls

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Contingency Planning
Area/
Responsible
Activity/ Risk Reaction Plan Other Alternatives
Person
Process

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Workshop….
Contingency Planning

Brainstorm in your groups to establish contingency

planning based on risks identified in the risk
assessment workshop
Present your work to the class

30 mins

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 5.6 Purchasing

5.6.1.1 Procedure
a)Determine criticality of activities or
products
c)Type and extent of control based on
criticality
e)Maintain list of approved suppliers and
scope of approval

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Workshop….
Critical and Noncritical Purchases
Brainstorm in your groups and determine critical
and noncritical purchases made by your company
Explain how you determined criticality of purchases
Present your work to the class

30 mins

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 5.6 Purchasing

5.6.1.2 Initial Supplier Evaluation-Critical

Purchases
Criteria for initial evaluation of critical
suppliers

5.6.1.3 Initial Supplier Evaluation-Noncritical

Purchases
Criteria for initial evaluation of noncritical
suppliers

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 5.6 Purchasing

5.6.1.4 Supplier Reevaluation

For all suppliers, 5.6.1.3 apply

5.6.1.6 Outsourcing
Maintain records of outsourced activities

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Workshop….
Initial Evaluation and Reevaluation
Brainstorm in your groups and determine the
criteria for initial evaluation and reevaluation of
critical and noncritical purchases made by your
company
Present your work to the class

30 mins

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 5.7.1.1 Production

Documented procedure address:

b)Product quality plan implementation (when
applicable)
c)Ensuring design requirements and related
changes are satisfied (when applicable)
d)Process control documents

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 5.7.1.2 Servicing

Documented procedure address:

d)Ensuring identification and traceability are
maintained throughout the servicing
process
f)Process control documents

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 5.7.1.3 Process Control Documents

Include
API product specifications
Required customer’s hold or witness points

5.7.1.4 Process Realization

Capability Documentation
Include
 Maintain evidence of capability to meet
product requirements

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 5.7.2 Product Quality Plans
When required by contract …….develop PQP that specifies QMS
processes and resources to be applied to product

Address at minimum
a)Description of product to be manufactured
b)Required processes and documentation including inspections, tests
and records
c)Identification and reference to control of outsourced activities
d)Identification of each procedure, specification, or other document
referenced or used in each activity
e)Identification of required hold, witness, monitor and document
review points

PQP and any revision documented, approved and communicated to

customer
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 5.7.2 Product Quality Plans

Also referred as
–Quality Plan (QP)
–Inspection and Test Plan (ITP)
–Manufacturing Process Specification (MPS)
–Process Control Plan (PCP)
–Quality Activity Plan (QAP)

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Workshop….
Product Quality Plan
Brainstorm in your groups to develop a PQP for a
new contract awarded to your company
Present your work to the class

30 mins

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 5.7.4 Product Inspection/Test
Status
Ensure only product that meets
requirements are released

5.7.6.2 Storage and Assessment

 Use designated storage areas or stock
rooms
 Interval of stock assessment appropriate
to product/part assessed
 Results of assessment maintained
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 5.7.7.3 Final Inspection and Testing
Performed based on product quality plan
and procedures to validate and document
conformity

5.8 Control of Testing, Measuring

and Monitoring Equipment
 Verify equipment from external source
 Maintain equipment registry including
unique identification

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 5.7.8 Preventive Maintenance
Maintain Documented procedure

Identify requirements for

a) Type of equipment to be maintained
b) Frequency
c) Responsible personnel

Maintain records

Can be based on risk, system reliability, usage history,

experience, industry recommended practices, relevant codes
and standards, OEM guidelines, or other applicable
requirements

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 Preventive Maintenance Plan

2014
Service
No Equipment Frequency
Checklist
1 2 3 4 5 6 7 8 9 10 1 1
1 2

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Workshop….
Preventive Maintenance
Brainstorm in your groups to identify key
equipment for preventive maintenance
Establish a Preventive Maintenance plan for the
identified key equipment
Present your work to the class

30 mins

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 5.10.2 Nonconforming Product

 Address NC product by one or more of the

following:
b) re-grade for alternative applications
c) Release under concession
d) Reject or scrap

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 5.11 Management of Change

5.11.1 General
Maintain MOC process
Integrity of QMS maintained when changes
planned and implemented
Identify potential risks associated with
change
Identify required approvals prior to
introduction of change
Maintain records of MOC activities
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 5.11 Management of Change
5.11.2 MOC Implementation

Use MOC process for the following that may

negatively impact product quality
a)changes in the organization structure,
b)changes in key or essential personnel,
c)changes in critical suppliers and/or
d)changes to procedures including those
resulting from corrective and preventive
actions
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 5.11 Management of Change

5.11.3 MOC Notification

Notify relevant personnel, including

customer when required by contract, of the
change and residual or new risk due to
changes that have been either initiated by
organization or requested by customer

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Workshop….
Management of Change
Brainstorm in your groups and discuss how MOC
process can be implemented to the kind of changes
assigned to your group (5.11.2 a-d)
Present your work to the class

30 mins

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 6.2.1 Customer Satisfaction
 Records of the results of customer
satisfaction information maintained.

6.2.2 Internal Audit

6.2.2.1 General
 Outsourced activities performed onsite
subject to internal audits

6.2.2.2 Performance of Internal Audit

 All QMS processes audited before claiming
conformance to API Spec Q1
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 6.3 Analysis of Data

 Data analysis outputs include information

relating to:
c)Nonconformities and product failures after
delivery or use
f)Quality objectives

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 6.4.2 Corrective Action

Procedure identify requirements for:

g)MOC when corrective actions require new
or changed controls within the system

 Records identify activities performed to

verify effectiveness of corrective actions
taken.

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 6.4.3 Preventive Action

Procedure identify requirements for:

g)MOC when preventive actions require new
or changed controls within the system

 Records of activities for control of potential

process nonconformities maintained.

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 6.5 Management Review

6.5.2 Input Requirements

Input include as a minimum:
e) Process performance
f) Results of risk assessment
h) Analysis of supplier performance

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Workshop….
Establish Documented Procedures
Brainstorm in your groups and establish
Documented Procedures for Risk Assessment and
Management, Contingency Planning, Preventive
Maintenance and Purchasing
Present your work to the class

30 mins

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