Welcome to QSI’s API Standardization Conference Newsletter (Exploration & Production)

Updates from the President

Bud Weightman snapshotI recently attended the American Petroleum Institute’s 2019 Summer Standardization Conference held in New Orleans, LA the week of June 24th. My main focus was on the following:

  • SC18 – Committee on Quality
  • API Monogram / APIQR Forum
  • SC20 – Supply Chain Management

Editorial Note

Some of the information in this version was previously published in the QSI Newsletter from the 2019 Winter Conference, all new information is color coded in green.

Important Changes

The following important changes are coming (click the link below to jump to section):


Honorable Mentions

  1. Austin Freeman
  2. Rick Faircloth

SC18 – Subcommittee on Quality

  1. Changes to the API Monogram Program
  2. API Spec. Q1, 9th Edition, Addendum 2
  3. When Product Specifications Change
  4. API Composite List
  5. API Spec. Q1, 10th Edition and ISO 9001:2015
  6. API Spec. Q2, Revision
  7. API Product Audit Questions
  8. Current Revisions of API Agreements
  9. Table of API Advisories
  10. Report from the API Monogram Program Board

SC20 – Subcommittee on Supply Chain Management

  1. 12 June Technical Session
  2. SC20 Document Matrix
  3. APIQR Quality Management System Registration Program for SC20 Service Standards
  4. SC20 Audits and Audit Nonconformities
  5. SC20 Document Revision Levels
  6. Future standards revisions or new releases

Citing of API Documents

Linkage of the Aforementioned Citing’s to Q1

Joining API Committees

API Licensing and Certification Activities

Important API Websites

Remember to Document Your Gap Analyses!

2020 API Winter Standardization Conference

Our Reputation.

Bud Weightman, President of QSI, is an international management systems expert involved with management and technical systems for over 40 years. As President of QSI, Bud is involved with the industry committees responsible for emerging requirements, including: revision of API specifications, leading various API Task Groups, and lead auditor for the accreditation of SEMS Audit Providers through the Center for Offshore Safety. Bud’s experience includes working with ISO 9001, ISO 14000, and OHSAS 18000 management systems, as well as industry-specific certification schemes such as API Q1 and Q2, AS9100, ASME systems, and numerous other standards.

ISO 9001:2015
API Spec. Q1
API Spec. Q2
API Lead Auditor

Learn the latest. Stay competitive with training.

 


Honorable Mentions

Austin Freeman

Dr. Austin Freeman, BP’s Technical Authority for Well Equipment, has been selected by the U.S. Celebration of World Standards Day Planning Committee as the 2019 recipient of the prestigious Ronald H. Brown Standards Leadership Award.

For more information, see the story at ANSI.org.

 

Rick Faircloth

On June 26th Rick Faircloth was awarded a Citation of Appreciation award from API. This award is API’s version of a lifetime achievement award. Presenting the award was Mr. Erik Milito, API Director of Upstream and he had the following comments.

Mr. Erik Milito, right, and Rick Faircloth, left

“Rick has long been appreciated for his skills as a consensus builder and is recognized for his leadership, technical skills, and significant contributions to the standardization program of the American Petroleum Institute. The API, its Committee on Standardization of Oilfield Equipment and Materials and the international petroleum and natural gas industry thank Rick for his lasting contributions.

“The American Petroleum Institute (API) recognizes Rick Faircloth for the leadership he has generously provided as Chairman of the Subcommittee on Supply Chain Management and his more than 35 years of service to the Committee on Standardization of Oilfield Equipment and Materials in Subcommittees 6, 18 and 20.

“During Rick’s tenure the Subcommittees have advanced work on several key documents covering castings, forgings, offshore bolting, quality and supply chain. Rick has also been a leader in chairing API’s task group on pipeline valves for 20 years, one of API’s most widely used standards, supporting worldwide safe and sustainable operations. And from this document, the industry has benefited from supporting documents on subsea valve operations, actuators and HPHT.”

Rick was also presented an award for his 40 years of participation with API standards development.


Subcommittee 18 Overview

Changes to the API Monogram Program

Here are some questions to consider with regards to the upcoming changes:

  • Are you prepared for the upcoming changes to the API Monogram Program?
  • Did you understand the changes required by API Spec. Q1, 9th Edition, Addendum 2? See API Spec. Q1, 9th Edition, Addendum 2 herein.
  • Have you made the required changes? The implementation date has passed; the date was 1 June 2019. If you have not implemented, then you are in nonconformance with your endorsed agreement with the API.
  • Are you aware that audits of licensees have gone from every 3 year to every year? See Changes to the API Monogram Program herein.
  • Are you aware that the API Monogram Program and APIQR agreements have been revised? See Section Current Revisions of API Agreements herein.

Here are the changes:

API Spec. Q1, 9th Edition, Addendum 2

API Spec. Q1, 10th Edition (inclusion of applicable ISO 9001:2015 requirements that are new to Q1)

New Product Specification Checklists

Read more: When Product Specifications Change

API Monogram Program Annual Audits

  • The API will be moving an annual audit system. Previously the audit was a licensing audit to an API Product Specification and API Spec. Q1 and was conducted every 3 years.  Based upon the number of suspensions and cancellations occurring to licensees, the API has instituted an annual audit system.
  • The plan will address:
    • A 3-year license renewal (this part hasn’t changed)
    • Annual surveillance audits, limited in scope
    • The API plans to increase resources to handle the addition demand.

Product Specification changes

  • Regular Scheduled Changes – Recommend that licensees regularly monitor the API Annual Standards Plan as part of your Management Review Process

 

What does the API Monogram mean to your bottom line financially?  Is it worth losing?

 

API Spec. Q1, 9th Edition, Addendum 2

Historic Overview

The implementation date for Addendum 2 has come and gone; the date was 1 June 2019.

What is the significance of Addendum 2?  In 2014 approximately more than 10,000 fasteners related to deepwater activities were replaced.  BSEE stated in their report that “There were QA/QC issues with second and third tier sub-contracted vendors that performed heat treatment processes and QA/QC manufacture, design, and material properties (hardness) issues with the bolts for effective subsea operation”.

The cause of the failure was related to hydrogen induced stress corrosion cracking due to hydrogen embrittlement.

BSEE further stated “The quality management system (QMS), which met the industry standards and certification programs, qualified and audited only first-tier level suppliers and not others in the supply chain. BSEE is encouraging industry to develop an improved quality management standard that addresses multiple tier subcontractors and promoting failure reporting involving critical safety equipment.

This is the catalyst that began the work to formulate the Addendum 2 changes to Q1.

For further reading, please read:

Supply Chain Risk

In addition to the information published by BSEE, there are other inherent supply chain risks; some examples are shown below:

Fasteners

Fastener failures have been an issue for decades; during the 1980’s industries such as the Nuclear and Aerospace Industries, including other realized the issues.  In circa 1990, the Fastener Quality Act was passed.

Fastener Quality Act (FQA) 15 U.S. Code 5401 / 15 CFR 280, Subchapter J (*) – Originally Published circa 1990
Issue: substandard, mismarked, misrepresented, and counterfeit fasteners; a threat to public safety

Remember that API Specs 20E and 20F could be used for contractual compliance.  See the SC20 Document Matrix herein.

Distributors

Traditionally some metallic metal distributors have had involvement with a variety of service companies such as heat treatment suppliers, mechanical testing suppliers and nondestructive examination suppliers.  However, distributors do not always have purchasing requirements for these activities.

Distributors could also include distributors of castings and forgings.  Sometimes original equipment manufacturers or their 1st tier suppliers do not identify purchasing requirements related to the original casting or forging supplier, such as but not limited to:

  • Weld repairs
  • Heat treatment
  • Mechanical testing
  • Nondestructive examination
  • Calibration activities for the above processes

Remember that API Standard 20J and 20H, including Specs 20A, 20B and/or 20C could be used for contractual compliance.  See the SC20 Document Matrix herein.

Machine Shops

Depending upon the original equipment manufacturer or their 1st tier suppliers, sometimes machine shops would be engaged to provide finished product.  Purchasers of machining services do not always consider activities such as purchasing activities related to material suppliers (see “Distributors” above), not to mention other outsourced activities such as coating or plating.

Remember that API Standard 20M could be used for contractual compliance.  See the SC20 Document Matrix herein.

Counterfeit Products

Counterfeit products have been identified through the US Department of Defense and the Aerospace industries as being a risk.  In fact, AS9100 D, “Quality Management Systems – Requirements for Aviation, Space, and Defense Organizations” has a section entitled “Prevention of Counterfeit Parts”.

The following product types represent the most counterfeited products:

  • Spare/replacement kits from vendors other than the Original Equipment Manufacture
  • Elastomer – “O” rings, seals
  • Welding Materials
  • Rod
  • Wire
  • Flux
  • Small piping products
  • Slings
  • Hooks
  • Cables

There are multiple publications related to counterfeit products on the internet.

Remember, some of the primary changes in Addendum 2 include:

  • The definition of supply chain
  • Ensuring that controls are in place for all supply chain levels
  • Identification of the words “product, component or activities”

The more tiers in your supply chain, the more your risk increases.

API Spec. Q1, Addendum 2, Training

Join us for API Spec Q1, 9th Edition, Addendum 2, Training to discuss the implications of adding these changes into your QMS.
Register Today!

 

When Product Specifications Change

The API will allow a company to be audited to a new revision of an API Product Specification prior to the revision effectivity date if the licensee feels they have implemented the changes and are ready for the audit.  In other words, in the case of API Spec. 5CT, the new revision is the 10th Edition which is dated June 2018; however, the date of effectivity is July 1, 2019.  If a company feels they have implemented the changes, they can request an audit to the new edition prior to the effectivity date.

API Composite List

The API Composite List webpage has been modified to provide more information.

Q1, 10th Edition & ISO 9001:2015

SC18 Task Group 2 has the responsibility to review the ISO 9001:2015 document and identify the changes that will be incorporated to API Spec. Q1. TG2 has held several meetings and began their efforts on Q1, 10th Edition changes.  It is anticipated that it will be complete sometime in 2019; however, the completion date will depend upon the new motions that were identified, voted upon and agreed to; the following new work items will be part of TG2’s responsibility.

Popular Software Apps for Compliance

Which software apps do most companies value to effectively track their quality management system?

♦  Document Control

♦  NCR & CAPA

♦  Competency & Training

♦  Calibration & Maintenance

♦  Change & Risk Management

The actions include *(1):

  1. Evaluating the scope of API Spec. Q1 to determine whether or not the document can be opened up to other types of organizations other than manufacturers. Reason: to provide a means of using Q1 in other than manufacturing specific applications.
  2. Compare the ISO 29001 *(2) and/or ISO DIS 29001 *(3) content to identify the differences between API Spec. Q1 and Spec. Q2. Reason: *(4)
  3. Evaluate the ISO DIS 29010 *(3 & 5) content related. Reason: *(4)

*Notes:

  1. The above wording has been provided at a high-level. The actual SC 18 Meeting Minutes will contain the actual language subcommittee leaders choose to use.
  2. The title of ISO 29001 is, Petroleum, petrochemical and natural gas industries — Sector-specific quality management systems — Requirements for product and service supply organizations
  3. DIS stands for Draft International Standard.
  4. To provide input to the US voting member for ISO TC 67, Materials, equipment and offshore structures for petroleum, petrochemical and natural gas industries operating management system standard for the petroleum, petrochemical and natural gas industries
  5. DIS 29001 will be related to Operating management systems for Oil and Gas Companies

API Spec. Q2, Revision

Q2 remains in the revision process.  The revision should be completed soon and the revised document should be submitted for ballot sometime this year.

Currently the Task Group is working with the International Association of Drilling Contractors and is attempting to set up beta site audits with volunteer drilling companies.

API Product Audit Questions

API product questions are in the process of being revised to better engage auditors in directly posing questions to the licensees.  The old methods of asking questions directly out of the product specifications will be totally discontinued.

The new method will focus on:

  • The specific products licensed to the licensee as published in the licensee’s scope on the API Composite list
  • Areas such as:
    • Design
    • Materials
    • Welding
    • Pressure Testing
    • Coating / Painting
    • Marking
    • Preparation for Shipment
    • Documentation
    • Facility Requirements
    • Normative Annexes

Input for the focus areas is received from the API Product Specification subcommittees.  This new methodology allows the auditor to be directly engaged and provides more flexibility.

Also remember that all API Product Specifications have a relationship to API Spec. Q1.  Essentially this means that the applicable product specifications are providing a bit more detail on some Spec. Q1 requirements.  Remember, this doesn’t mean that the product specs replace Q1 requirements, but supplement them.

The following is an illustration of how specific API Spec. Q1 sections are interrelated with product specifications:

Q1 Requirement Product Specification Requirement
Acceptance Criteria

  • 5.4.3 Design Acceptance Criteria
  • 5.6.2 Purchasing Information
  • 5.7.1.3 Process Control Documents
  • 5.7.1.5 Validation of Processes for Production and Servicing
  • 5.7.7.2 In-process Inspection and Testing
  • 5.8 Control of Testing, Measuring, and Monitoring Equipment
  • 5.10.3 Manufacturing Acceptance Criteria
  • Design Criteria
  • Material Specification Criteria
  • Visual Criteria
  • Dimensional Criteria
  • Hardness Testing Criteria
  • Nondestructive Examination Criteria
  • Welding Criteria
  • Heat Treating Criteria
  • Test Criteria
  • Coating and Plating Criteria
4.3.2.2 Personnel Competence Quality Control Personnel Qualifications

  • Nondestructive Examination Personnel
  • Visual Examination Personnel
  • Welding Inspectors
  • Welder Qualification
4.4.3 Control of Documents Like words shown in the spec. such as:

  • Manufacturer’s written specification
  • Procedure
  • Operating Manual
  • Instruction
  • Manufacturer Instructions
  • Quality Control Instructions
  • Manufacturer’s documented instructions
4.4.4 Use of External Documents in Product Realization Normative References
4.5 Control of Records
  • Quality Control Records
  • Documentation
  • Record
  • Retention
5.4 Design and Development Design and Material Requirements
5.7.1.5 Validation of Processes for Production and Servicing Specific requirements for processes such as:

  • Heat Treating
  • Welding
  • Nondestructive Examination
5.7.3 Identification and Traceability Identification, Traceability, Serialization
5.7.6 Preservation of Product
  • Preservation Requirements
  • Packaging Requirements
  • Shipping Requirements
5.7.7 Inspection and Testing Visual and dimensional inspection, nondestructive examination, welding inspection, drift testing, hydrostatic testing
5.7.8 Preventive Maintenance Maintenance Requirements
5.8 Control of Testing, Measuring, and Monitoring Equipment
  • Calibration Procedure
  • Calibration Intervals
  • Controls for Specific Types of Equipment
  • Calibration Frequency
Annex A, Application of the API Monogram Annexes, Application of the API Monogram

Current Revisions of API Agreements

Be sure to visit the following API webpages for updates to program agreements.  As an example, the following have specified requirements for performing “ethics” training.

Note:   See the Table of API Advisories below, particularly Advisory #7.

Table of API Advisories

The following table was extracted from API’s website for your information; please check the website for the current updates.

Advisory Scope
Advisory #1: API Procedures Concerning Communications with Third Parties, June 2, 2016
Advisory #3: Recognition and Authority of Management Representative, April 13, 2016
Advisory #6: Design and Development Exclusion under the API Monogram Program, May 10, 2019
Advisory #7: Code of Conduct for API Monogram Licensees, APIQR Certified Organizations and Program Applicants, April 13, 2016; including

  • API Code of Ethics & Code of Conduct Poster
Advisory #9: Recognition and Authority of Published Standards, November 8, 2016
Advisory #10: Invoicing and Payment Terms for API Invoices, March 22, 2019
Advisory #11: API Monogram Manufacturing Requirements, Manufacturing Capabilities, and updated Licensing Agreement, May 7, 2018

Report from the API Monogram Program Board

A report was given by Dr. Austin Freeman, BP of the API Monogram Program Board.  Here are the highlights:

  • Information about API Quality Registrar’s activities:
    • APIQR will phase out management system certification to OAHAS 18001, “Occupational health and safety management systems-Requirements with guidance for use” by 2021
    • APIQR does not intend to perform management system certifications to ISO 45001, “Occupational health and safety management systems-Requirements with guidance for use”
  • Information about upcoming implementation due dates of API Product Specifications:
    • API Spec. 5CT, “Specification for Casing and Tubing”, Tenth Edition, Includes Errata 1 (2018) and Errata 2 (2019) is due to be implemented by 1 July 2019
    • API Spec. 6A, “Specification for Wellhead and Tree Equipment”, Twenty-First Edition, Includes Errata 1 (2019) is due to be implemented by 1 November 2019

See the section herein “Remember to Document Your Gap Analyses!


Subcommittee 20 Overview – Subcommittee on Supply Chain Management

12 June Technical Session

A Technical Session was presented on June 12th at the 2018 Summer Conference. SC20 was invited to give presentations on the SC20 service standards to familiarize attendees and subcommittee chairpersons with these activities.

The following presentations were given:

Standard Title Presented By
SC20 API Upstream Standard Development – Supply Chain Management Rick Faircloth – SC20 Chairman; Cameron, a Schlumberger Company, Valves & Measurement
20D Nondestructive Examination Services for Equipment Used in the Petroleum
and Natural Gas Industry
Neal Ferguson – SC20 Vice Chairman, Element
20H Heat Treatments Services – Batch Type for Equipment Used in the
Petroleum and Natural Gas Industries
Joel Russo, Chairman, Technip FMC
20J Qualification of Distributors of Metallic Materials for Use in the
Petroleum and Natural Gas Industries
Jason Price, Fastenal
20M Qualification of Suppliers of Machining Services for Use in the
Petroleum and Natural Gas Industries
Bud Weightman, TG Chairman, Qualified Specialists International

These presentations are available on the API SC20 webpage and are available for download.

SC20 Document Matrix

API Spec. / Standard Title Notes *Specification
(Eligible for API License)
**Standard
(Eligible for QMS Certification)
# of Companies Licensed / Registered Comments
20A* Carbon Steel, Alloy Steel, Stainless Steel, and Nickel Base Alloy Castings for Use in the Petroleum and Natural Gas Industry NA X NA 6D, 25th Edition contains a referenced to 20A

14 audit nonconformities

20B* Open Die Shaped Forgings for Use in the Petroleum and Natural Gas Industry NA X NA 29 8 audit nonconformities
20C* Closed Die Forgings for Use in the Petroleum and Natural Gas Industry NA X NA 15 58 audit nonconformities
20D** Nondestructive Examination Services for Equipment Used in the Petroleum and Natural Gas Industry NA NA X 0 APIQR is developing a registration program / 48 copies of the standard have been sold as the date of this publication

A revision is being considered to include UT Phased Array for in situ bolding.  This change is being considered as a result of subcommittee activities for Spec. 16A and reference to API Standard 53.

20E* Alloy and Carbon Steel Bolting for Use in the Petroleum and Natural Gas Industries NA X NA 38 84 audit nonconformities
20F* Corrosion Resistant Bolting for Use in the Petroleum and Natural Gas Industries NA X NA 18
20G** Qualification of Welding Suppliers for Equipment Used in the Petroleum and Natural Gas Industry Out for Ballot NA X NA Tentative publication Q3 or Q4, 2019
20H** Heat Treatment Services – Batch Type for Equipment Used in the Petroleum and Natural Gas Industry NA NA X 1 APIQR is developing a registration program / 65 copies of the standard have been sold as the date of this publication
20J** Qualification of Distributors of Metallic Materials for Use in the Petroleum and Natural Gas Industries NA NA X 2 APIQR is developing a registration program / 30 copies of the standard have been sold as the date of this publication

Table 2 for 20J is being updated

20L** Qualification of Non-Metallic Seal Suppliers for Equipment Used in the Petroleum and Natural Gas Industry NA NA X 0 Published 2018; 20L is referenced in Spec. 16A

APIQR is developing a registration program / 12 copies of the standard have been sold as the date of this publication

20M** Qualification of Suppliers of Machining Services for Use in the Petroleum and Natural Gas Industries NA NA X 1 APIQR is developing a registration program / 18 copies of the standard have been sold as the date of this publication
20N** Heat Treatment Services – Continuous Furnace for Equipment Used in the Petroleum and Natural Gas Industry Final Draft NA X NA
20P** Qualification of Suppliers for Plating and Coating used in the Petroleum and Natural Gas Industries Ready for Ballot NA X NA Ready for ballot
20R** Qualification of Suppliers of Subsurface electronics for use in the Petroleum and Natural Gas Industry Under Development NA X NA
20S** Subject matter: Additive Manufacturing New Committee Motion NA X NA
APIQR Quality Management System Registration Program for SC20 Service Standards

You will see in the comments section that numerous SC20 API Standards have been sold.  Each row explains the number of standards sold, with a total of 176 documents sold.  Why is this important?

The count is a result of APIQR’s survey to determine the level of interest in the SC20 Service Standards based upon this information

SC20 Audits and Audit Nonconformities

The comments in the SC20 Document Matrix identify the number of audit nonconformities tracked by the API between the periods of January 2018 through May 2019.

SC20 Document Revision Levels

Check one of the following sources for document revision level:

Future standards revisions or new releases

The following documents will be moving towards a revision.

API Spec. / Standard Title Date
20C* Closed Die Forgings for Use in the Petroleum and Natural Gas Industry 2020
20D** Nondestructive Examination Services for Equipment Used in the Petroleum and Natural Gas Industry 2019
20G** Qualification of Welding Suppliers for Equipment Used in the Petroleum and Natural Gas Industry 2019
20H** Heat Treatment Services – Batch Type for Equipment Used in the Petroleum and Natural Gas Industry 2020
20N** Heat Treatment Services – Continuous Furnace for Equipment Used in the Petroleum and Natural Gas Industry 2019
20P** Qualification of Suppliers for Plating and Coating used in the Petroleum and Natural Gas Industries 2020
Citing of API Documents

The API reported that API documents have been cited in 4,785 federal, state and international regulations.

What impact could this have on your quality management system?
An association could easily be drawn between the quality management system and:

  • The identification and evaluation of statutory and/or regulatory documents as specified by Q1, section 4.4.4 Use of External Documents in Product Realization
  • Whether or not statutory and regulatory requirements have been considered in processes such as design input, product realization and purchasing

 Linkage of the Aforementioned Citing’s to Q1

Q1 Section Wording
3.1.13
legal requirement
…statutory or regulatory
3.1.5
compliance
…regulation or regulatory body
3.1.9
design validation
…regulatory requirements
3.1.14
Management
…legal
4.1.5 Communication
4.1.5.1 Internal
…legal
4.4 Documentation Requirements
4.4.1 General
…legal
4.5 Control of Records …legal
5 Product Realization
5.1.2 Determination of Requirements
…legal
5.2 Planning …legal
5.4.2 Design and Development Planning …legal
5.6.1.2 Initial Supplier Evaluation—Critical Purchases …legal
6.5 Management Review
6.5.2 Input requirements
…legal
Joining API Committees

Related to the API specifications and standards, from time to time I hear questions about “why did API do that?”  Well, the bad news is that the API didn’t do anything.  Changes come from voting or balloted decisions.  The changes are a result of the “industry’s” needs.

Please get involved!

It’s important for licensed companies, including quality management system registered companies to participate in the API Standardization Activities.  While any position within a company may attend, typically, a company’s Quality and Engineering Departments participate.

There are typically 2 API Standardization Conferences a year; 1 conference in winter (typically towards the end of January) and 1 conference in the summer (typically towards the end of June).  In addition to this, depending upon the API Exploration and Production subcommittees, numerous work groups and task groups are available for participation that perform subcommittee directed work in between conferences.

The location of the winter conferences typically occur in Texas, while the summer conferences may be located in other (typically) oil and gas producing areas such as Louisiana, Canada, Colorado  Venues for the conferences can be found on API’s Events website which also shows the 2020 Exploration and Production Winter Standards Meeting in Ft. Worth Texas; January 20, 2020 to January 24, 2020.

API Licensing and Certification Activities

Here are some interesting statistics:

Number of Registrations
2018 2019
2343 Monogram only
646 APIQR only
546 Dual Customers

 

Number of Licenses / Licensees
2018 2019     
6261 6006 Licenses
3910 3566 Licensees

 

% of Spec.
US 19%
China 37%
India 4%

 Important API Websites

Remember to Document Your Gap Analyses!

Based upon all the upcoming changes to API documents, it is extremely important that you remember to document your gap analyses.

QSI’s expert consulting services conducts open, yet structured, gap analyses and involves input from senior level management and other key personnel – no matter your type of product, service, or industry. Read more…

While it may seem that this is business as usual, companies licensed under an API product specification or who have a quality management system certification are obliged to follow API Spec. Q1, Clause 4.4.4, Use of External Documents in Product Realization which states:

When API product or other external specification requirements, including addenda, errata, and updates, are used in the design or manufacture of the product, the organization shall maintain a documented procedure for the integration of these requirements into the product realization process and any other affected processes.”

In other words, this means a consideration whether or not:

  • gap analysis will need to be performed to document the differences between the previous and the new revisions.
  • A determination will need to be made as to whether or not the changes to any product specifications represent a risk to your existing design and/or current quality management system (i.e., a risk assessment to Q1, Section 5.3) and whether or not changes need to be made.
  • If the changes present a risk, then a risk assessment will need to be documented.
  • If changes are to be made, a management of change will need to be implemented with regards to the impact the revised specification will have upon your quality management system and related documentation.
  • Upon making all the changes, relevant personnel will need to be trained; the training will need to be documented and training effectiveness will have to be determined.
  • Subsequently all the changes will have to be implemented.

QSI offers a variety of software applications and supporting documentation to help keep your QMS in compliance, regardless of upcoming revisions to industry standards or specs. Our applications include:

You can customize the applications to meet your company’s needs, no matter your company’s size. View a comprehensive list of all software applications here.


Be aware that the API Monogram Program Licensing Requirements have been revised; you can view them here.

Keep your eyes open for document changes on API’s website at:

2020 API Winter Standardization Conference

Don’t forget to register for the 2020 API Winter Standardization Conference.

Date: Week of January 20, 2020 to January 24, 2020
Location: Omni Fort Worth Hotel, Fort Worth, Texas
Register: See API Events Calendar (Registration Coming Soon)