API Spec Q1 9th Edition Training Slides-R1

 

API Specification Q1 9th Edition Training Welcome to the Training!

Trainer Name: Teevakaren Battumalai

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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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SAFER, SMARTER, GREENER 

 

What will you learn? What

is API Specification Q1 9th Edition all about?

What

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

Slide DNV GL © 2013 5,

issue  

How this course is built up Introduction

Group activities

Brainstorming Terminology and Concepts

Theoretical input Key Changes and Requirements

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Reflection

 

How to to Contribute Contribute Today Illustration coming

Learning ne new th things is is de demanding, bu but fu fun

Illustration coming

There are no stupid questions DNV GL © 2013

Illustration coming

Active pa participation

Illustration coming

Benefit from sharing experiences

 

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   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 

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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



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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. 13

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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

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

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 Minimize

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defect prevention

variation and waste

 

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 likelihood of nonconformity

minimize

the

 Promotes

reliability in the manufacturing sector of petroleum and natural gas industry

 Promotes

Approach

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the

integration

of

a

Process

 

Benefits of API Spec Q1 9 th Edition Certification  Meet

oil and gas industry and customer demands for API certified or licensed products

 Increase

revenues competitors

 Increased

and

overcome

your

product credibility due to API

Spec Q1 certification and monogram license  Improve operations and reduce risks within your organization 17

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API Spec Q1 Structure Section 1 Scope

Section 2 Normative references

General Exclusion

 

Latest edition of referenced document document apply (ISO 9000)

ISO 9000 applies

Section 3 Terms, Definitions, and Abbreviations

Definitions in Q1 apply for identical terms

Section 4-6 Requirements

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 8 th Ed to API Q1 9th Ed

Bibliography 18

4. Quality Management System 5. Product Realization 6. Monitoring, Measurement, Analysis, Improvement

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Overview of the API Monogram Program  API

Monogram is a registered certification certificatio n 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 specificatio specification n

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TERMINOLOGY AND CONCEPTS

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Management System

Management System – System – system to establish policy and objectives and to achieve those objectives ISO 9000, 3.2.2

Quality Management System 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 – 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 Objectives – 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

Methods

Equipment

Environment

Inputs

Output

Monitor and Measure Effectiveness

Apply changes / corrections

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



10 mins

your work to the class

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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 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 includes:

and

authority

that

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 require validation

of

processes

that

e) requirements Identification of legal and other applicable

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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 required by QMS are controlled

and

forms

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 changes occur

shall

be

updated

as

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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/equipmen a) Facility/equipmentt availability and maintenanc maintenance e b)Supplier b) Supplier performance and material availability/ supply Risk

assessment associated with product quality

include a)Delivery a) Delivery of nonconfo nonconforming rming product b)Availability b) Availability of competen competentt 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 associated with preventive action

can be an corrective

activity and/or

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Risk Register Area/ Activity/ Process

S - Severity

Mitigation Risk

Impact

O – Occurrence

S

Current Risk Controls

RPN – Risk Priority Number

O

RPN

Risk level

RPN = S x O

Action

PIC

Date

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Risk Identification and Assessment - Sample Area/ Activity/ Process Suppliers

Current Risk Controls Risk

Impact

Cannot deliver raw material

• •

Disruption to production Cannot deliver to customer

Quality issues

•

Disruption to production

Financial trouble

•

Disruption to production Cannot delivery to customer

•

S - Severity

O – Occurrence

S

4

Prevention •

New Supplier Assessment based on established criteria

Detection •

Ongoing supplier performance monitoring

Mitigation O

R PN

Risk level

2

8

M

and assessment

RPN – Risk Priority Number

RPN = S x O

Action

PIC

Supplier Audit program

XX

Date XXXX

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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

Disruption to customer operation but no stoppage

3

Minor Disruption

Slight inconvenience to customer operation

2

No effect

No discernible effect

1

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Risk Assessment Criteria – Occurrence Rating OCCURRENCE (Likelihood)

EXAMPLE

RATING

Most Likely

The most likely result of the risk being realized

5

Possible Conceivable

Has a good chance of occurring and is not unusual Might occur at sometime in future

4 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 (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

SEVERITY (S)

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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

45 mins

your work to the class

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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 responsibilities and authorities c) Internal controls

and

external

of

communication

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Contingency Planning Area/ Activity/ Process

Risk

Reaction Plan

Other Alternatives

Responsible Person

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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 products c)Type and criticality

criticality  criticality  extent

of

of

activities

control

based

or on

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 Purchases Criteria

for

Supplier initial

Evaluation-Critical

evaluation

of

critical

suppliers 5.6.1.3 Initial Supplier Evaluation-Noncritical Purchases Criteria

for initial evaluation of noncritical

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

PQP and any revision documented, approved and communicated to

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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 requirements are released

that

meets

5.7.6.2 Storage and Assessment  Use

designated storage areas or stock rooms  Interval of stock assessment appropriate to product/part assessed

 Results 72

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

Can

records

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 No

Equipment

Frequency

Service Checklist

1

2

3

4

5

6

7

8

9

10 10

1 1

1 2

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Workshop…. Preventive Maintenance Brainstorm

in your groups to identify equipment for preventive maintenance



key

Establish key a Preventive identified equipment Maintenance plan for the

Present

30 mins

your work to the class

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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

change Identify required approvals introduction of change

prior

with to

Maintain 78

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 a) changes in the organization structure, b)changes b) changes in key or essential personnel, c)changes in critical suppliers and/or c)changes d)changes d) changes to procedures including those resulting from corrective and preventive

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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

30 mins

your work to the class

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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 subject to internal audits

onsite

6.2.2.2 Performance of Internal Audit  All

QMS processes audited before claiming

conformance to API Spec Q1 82

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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

30 mins

your work to the class

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