Introduction into the New Quality Management System – API Q1 9th Ed.

Suresh Chaugule
 Agenda
• What is a QMS?
• Why a New QMS?
• Overview on Revised API – Q1 Requirements
• How to Access New QMS Folder?
• QMS Implementation Plan – Schedule
• Employee Involvement
• Question & Answer Session
• Suggestion / Recommendation
 What Is QMS?
Quality Management System

Business Management System

• For planning and executing business processes

• To meet customer requirements
 4.1 General Requirements
• The organization shall establish, document, implement, and
maintain at all times a quality management system for all
products and servicing provided for use in the petroleum and
natural gas industry………shall measure the effectiveness and
improve………
• Quality Policy
• Quality Objectives
• Planning
• Communication (internal and external)
 Quality Policy
• Top management must create a
documented and approved quality policy
that;
• fits the organization
• includes continuous improvement and
• incorporates quality objectives
• Communicated and understood at all levels
 Quality Objectives
• Declaration of Quality Objectives:
• QA/QC
– Improve On-Time Delivery by 10%.
– Reduce Customer Complaints (NCR’s) by 5%.
– Increase Internal Audits by 10%.
• Engineering: Implement new part numbering
system for Gate Valves (Target – end of year).
– Upload design files in Syteline system (Target – end of
year for project after 2005).
• Purchasing: To have Vendors to 95% to 100% on-
time delivery with correct documentation.
 Quality Policy
• The Quality Policy of Worldwide Oilfield Machine,
Inc. Is to meet or exceed the quality standards
expected by our customer by providing the finest
quality products and services as we become the
premier supplier of Well Control System and
Products.
• WOM, Inc. is committed to comply with the
requirements of industry regulated bodies (API
Q1and ISO 9001:2008) by showing continual
improvements to the effectiveness of the Quality
Management System.
4.2 Management Responsibility
• Top management shall ensure the availability of
resources essential to establish, implement,
maintain, and improve the quality management
system.
• Responsibility and Authority
• Management Representative
Organization Capability
• Provision of Resources
• Human Resources
– Personnel competence
– Training and awareness
• Work Environment
4.2 Documentation Requirements
• Quality Manual
• Procedures
• Control of Documents (internal and external)
• Control of Records
Sect. 5 Product Realization
• 5.1 Contract Review
– Determination and Review of Requirements
• 5.2 Planning
• 5.3 Risk Assessment and Management * new
• 5.4 Design and Development
• 5.5 Contingency Planning * new
– Planning output
Sect. 5 Product Realization – cont.
• 5.6 Purchasing **
– Control, Supplier eval, reevaluation, records, outsourcing
& verification of purchased product
• 5.7 Production and Servicing **
– Process control docs, capability documentation, validation
of processes, traceability, product status, customer
property, product preservation, storage, Inspection &
testing (in-process and final) and preventive maintenance
Sect. 5 Product Realization – cont.
• 5.8 Calibration
• 5.9 Product Release
• 5.10 Control of Nonconforming Product
– Release under concession
– Customer notification
– MOC Implementation & Notification * new
Sect. 6 – QMS Monitoring, Measurement Analysis &
Improvement
• 6.1 QMS Monitoring, Measurement Analysis &
Improvement
• 6.2 Monitor and Measure
– Customer Satisfaction, Internal Audit, Audit review
and Closure, Process evaluation
• 6.3 Analysis of Data
• 6.4 Improvement
– Corrective action & preventive action
Sect. 6 – QMS Monitoring, Measurement Analysis &
Improvement – cont.
• 6.5 Management Review
• effectiveness of actions resulting from previous
management reviews;
• results of audits
• changes that could affect the quality
management system, including changes to legal
and other applicable requirements (such as
industry standards);
• analysis of customer satisfaction, including
customer feedback
Sect. 6 – QMS Monitoring, Measurement Analysis &
Improvement – cont.
• 6.5 Management Review
• process performance
• results of risk assessment
• status of corrective and preventive actions
• analysis of supplier performance
• review of the analysis of product conformity,
including nonconformities identified after
delivery or use
• recommendations for improvement.
– Output requirements
Overview of Documented Q.M.S

INTENT
Quality Policy
Quality Objectives

Level –I
QM Procedures Quality Manual WHAT?

Level – II
P- Procedures
Procedure HOW?
WHY?
Level – III
(WI - Document
Work Instruction / WOM
Specification
Level - IV
Records / Forms PROOF
 Why a New QMS ?
• API Spec Q1 – Revised Edition
– Process Based Management System
– Risk Based Management System
• Missing co-relation between processes and reference
documents in previous QMS
• Missing Roles and Responsibilities
 Overview on API Spec Q1
• Specification For QMS Requirements for
Manufacturing Organizations for Petroleum & Natural
Gas Industry
• Requirements for organization that manufactures
products or provide manufacturing – related processes
for use in petroleum and natural gas industry
Changes in API Q1 – 9th Edition
Competency & Risk Assessment & Contingency
Training of Personnel Management Planning
(HR) (All Departments) (All Departments)

Design Overview /
Service Quality Planning
Validation
(RRS) (QA)
(Engg)

Preventive Supply Chain Management of

Maintenance Control Change
(Manufacturing) (Purchasing ) (Top Management)
 Competency of Personnel
• Most of the organization doing this in one form or
another
• Spec Q1 requires more formal approach
• Particularly interested in skill assessment and
development of training matrices to ensure a
competent
 Risk Management
• Risk Assessment and Management is a major
component in Spec Q1
• Spec Q1 ask us to create a formalize process to identify
and document risk (potential & real)and then develop
an action plans designed to communicate, mitigate &
control these risks
• Goal is to reduce or avoid exposure to loss
 Contingency Planning
• Disruption Prevention
• Actions required for significant risk
• Assignment of responsibility and authority
• Internal & External Communication
 Design Review
• Design Review is very straight forward
• This requirement deals with the verification &
validation of product and process
• One item of note is we see the risk assessment
function identifies in the design process
 Supply Chain Controls
• Supply Chain Controls are imperative
• In most cases organizations have some process in place
• Spec Q1 requires much more formal and documented approach to
supplier management
Develop methods to classify and qualify suppliers
Assess and identify critical suppliers
Verify that QMS is in place for internal requirement
Track and report supplier performance Metrix

• Ultimately our goals are here to minimize potential disruptions to

operations and maximize cost savings
 Quality Planning
• Designed to document the procedures, resources, processes and
activities that identify and control the quality requirements of product
• Q1 requires organization to clearly define; document and measure
items associated with the production process
• Quality plans should include :
• Compliance to customer requirement
• Control of subcontractors
• Identification of requirements for acceptance
• Identification and control of risk
• Required deliverables and related records
• Plans need to be documented and approved and when required by
contract, communicated with customer
 Preventive Maintenance
• Spec Q1 requires detailed, site specific maintenance
schedules, procedures and training
• Maintenance procedure should include
» Preventive Maintenance
» Use History Logs
» Critical Spare Parts
» Controls for Equipment Integrity
 Management of Change
• Management of Change program is used to
demonstrate an organization’s commitment toward
due diligence in risk mitigation efforts
• This shall include communication with internal and
external parties
How to Access QMS Files & Folders?
• New QMS Folder
\\magnummail\wom\PDF Specs\New Quality Manual System\API Level I\QA Procedures PDF

• Level I (Quality Manual /QM- Procedures)

\\magnummail\wom\PDF Specs\New Quality Manual System\Level I - QM Procedures

• Level II (Process / P- Procedures)

\\magnummail\wom\PDF Specs\New Quality Manual System\Level II P- Procedure\P Procedures

• Level III (Work Instruction / WOM Specification)

\\magnummail\wom\PDF Specs\New Quality Manual System\Level III WI

• Level IV (QA Forms)

\\magnummail\wom\PDF Specs\New Quality Manual System\Level IV
 Next Steps
• Review timeline for implementation
• Conduct Training on the standard
• Procedure training and use
• Execute implementation plan and timeline
QMS Implementation Plan - Schedule
Milestones Due Dates Status
1. Define Quality Policy 6-1-2014 Done
2. Define Departmental Measurable Quality 1-31-2015 Pending (Overdue)
Objective
3. Prepare & Review QM / PM Procedures 2-11-2015 Pending
4. Prepare Departmental Work Instruction On-going Covered for majority of
Activity department
5. Document / Record Control 2-12-2015 Pending
6. Training 2-13-2015 Pending
7. Internal Audit 2-20-2015 Pending
Employee Involvement Through

– Leadership
– Determination
– Resilience
– Commitment
– Engagement
Question & Answer