Quality Corner

Annual Audits Coming for the API Monogram Program

2/28/2019

Is your API-Certified Facility affected by the new Monogram Program Auditing update? Previously, facilities were able to apply for a Monogram License only and a re-certification audit would occur every three years if the company did not apply for a quality registration (ISO 9001, API Q1, API Q2, ISO 14001, or OHSAS 18001). The facility still had to meet the requirements of API Q1 as required by the Monogram Program but would not be audited every year, saving in audit costs by API. Things have changed.

As industry leaders demand more consistent products and stricter surveillance programs on manufacturers, API and its standards committees have answered the call by implementing annual audits for all facilities under their licensing programs.

What does this mean for your facility?

Only those with a Monogram Licenses that are not registered with a quality standard will be affected. This also depends on where the license expiration falls in the calendar year. If your Monogram License expires on or before June 30th, 2019, the annual audits will not begin until 2022. If your license expires after June 30th, 2019, the rule will go into effect immediately. If your license expires in 2020, the annual audits will begin after the renewal audit that same year and the same rule applies in the year 2021. Here is a chart to assist with determining what audit cycle your facility may fall under:

How to prepare

This new program change will mean more accountability from the industry and more pressure to maintain a quality program throughout the lifecycle of the certification. In times past, a majority of facilities with only a Monogram License that were audited every 3 years failed their audit and were required to be re-audited by API. Not only did this result in further audit costs, but also a suspension of the license during the long process of scheduling a re-audit and determining if responses to non-conformances met the expectations and requirements of the program.

Facilities will now have to maintain their programs every year. In theory, this was supposed to occur and companies should have maintained compliance with API Q1 at all times when they possessed an active Monogram License. In reality, many quality management system fell apart during this three-year time period and were only held accountable by either a surprise API audit or industry peers filing complaints about product non-conformances.

Now that annual audits will be conducted for all API-licensed and registered facilities, companies will need to be in regular preparedness for an API Audit or face the consequences of a suspension or worse, a canceled license and the long process of reapplying. Yes, this is a positive step for the Oil & Gas industry but it’s going to require more attention and costs to maintain quality and product licenses.

Click for the official API Announcement Letter

CLICK for more information about Capstone Quality Services, LLC and to set up a free consultation on how our services can help your company achieve its certification objectives.

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Analysis: ISO 9001: 2008 Transition to ISO 9001: 2015

12/3/2018

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ISO 9001 is the world's most recognized management system standards and is currently being used by over a million companies and organizations throughout the world. This standard provides guidance and tools for organizations to ensure that their products and services consistently meet customer’s requirements and that quality is consistently improved over time. Regardless of size, industry, or language this standard can be followed in order to improve the management system structure and ensure deliverability of product or service to customers. This standard is based on many quality management principles including the continual improvement, process approach, motivation and implication of top management and customer-driven focus.

Throughout this guide, we will walk you through various sections of ISO 9001 to compare and contrast the new 2015 edition in order to better your understanding of how to prepare your system for your next audit.

Benefits of ISO 9001 Quality Management

Increases your competitiveness within your industry.
Demonstration of this standard by attaining a certificate of compliance will win business for your organization.Helps meet your customer’s needs and increase customer satisfaction and retention.
Employees of your organization will feel more engagement and therefore improve their efficiency and internal processes.
Improved operational performance will reduce errors and increase profits.
Increases in efficiencies that will save you and your company time, money and valuable resources.

ISO 9001-2015 transition outline

Quality Management Principles
1. ISO 9001: 2008
  1. Customer Focus
  2. Leadership
  3. People involvement
  4. Process approach
  5. System approach to management
  6. Continual improvement
  7. Factual approach to decision-making
  8. Mutually beneficial supplier relationships
2. ISO 9001: 2015
  1. Customer Focus
  2. Leadership
  3. Engagement of People
  4. Process approach
  5. Improvement
  6. evidence=based decision-making
  7. Relationship management
Integration with other ISO Standards
1. Annex SL Framework, ISO 9001: 2015 has 10 clauses with compliance requirements covered by clause 4 to clause 10. ISO 14001: 2015, ISO 27001: 2013 and ISO 45001 follow the same framework making the integration of ISO 9001: 2015 easily integrated with these other standards. This also ensures a better structured PDCA (see chart).

The Context of the Organization
1. Use SWOT (Strengths, weaknesses, opportunities, threats) and PESTLE (political, economical, social, technological, legal and environmental) analysis if required. Both of these acronyms and management tools can assist you when considering your vision, mission, strategic direction and intended outcome of your QMS. ISO 9001: 2015 is an approach to a unified management system that integrates your business and functions into a system rather than a stand-alone document.
External issues and internal issues
1. Identification of internal and external issues that affect your organization are critical to your current success and continual improvement. These can be positive or negative but the effect on your organization is critical to understanding how your business evolves over time. After the identification of these factors, determine whether or not there are risks and/or opportunities related to these issues. Review these factors often to keep your company relevant and topical.
Interested Parties
1. Identify interested parties and stakeholders in your company (suppliers, customers, or competitors. What is their needs and expectations and impact on your business if these needs and expectations are not fulfilled.
Documented information
1. Control of documents and control of records of ISO 9001: 2008 are now combined as documented information and there isn’t a major change in the expected compliance. You may decide if a documented procedure is required or not depending on your organization’s needs. It is important however to ensure version control on documents, control on creation, approval, distribution, and changes to documents. Identify retention period, location, disposal or archival mechanism of records, etc.
Quality Objectives
1. Ensure that quality objectives include objectives covering process/service/product non-conformity and customer satisfaction. Continue using SMART - Specific, measurable, achievable, realistic and time bound quality objectives determined at relevant functions and levels within the organization.
Quality Policy
1. Your quality policy can be made available to relevant interested parties and you may determine the method for this communication. Management also should be responsible for the distribution of this quality policy to the employees of the organization and more importantly, that the employees understand and follow this policy.
Quality Manual
1. ISO 9001:2015 has removed the requirement of having a quality manual in order to replace the documented oriented approach is replaced with a performance-oriented approach. Why have a quality manual if it is only opened during your annual QMS audit? If however your QM is a live document and is continually used to improve your organization and referenced throughout the year then by all means keep the manual.
QMS Awareness
1. Your organization shall ensure employees are aware of the quality policy and relevant objectives. The integration throughout your organization is important and for employees to take ownership of the policies and procedures. This ensures greater effectiveness and usefulness of your QMS.
Fewer Prescribed Requirements
1. There are fewer prescribed requirements and ISO 9001: 2015 edition is no longer a document-oriented approach. The focus is on performance and achievement. The new addition lets you and your company decide the level of complexity.
Mandatory Procedures and Standard Operating Procedures
1. Six mandatory documented procedures required in ISO 9001: 2008 are now optional and include the following: control of documents, control of records, control of nonconformity, internal audit, corrective actions and preventive actions. The decision now lies with your organization on whether or not to document these procedures. If your organization determines not to document these, make sure it is justified and if having them or not having them is a positive or negative for your business.
Exclusions
1. ISO 9001: 2008 used the word “exclusion” while ISO 9001: 2015 uses the phrase “requirements that cannot be applied.” ISO 9001: 2008 allows exclusions under product realization requirements if they cannot be applied and if doing so doesn’t interfere with its ability or responsibility to meet customer and legal requirements. ISO 9001: 2015 has a similar approach but is open to all clauses throughout the standard. When taking this approach, be sure to consider the scope of your organization and provide ample justification for any exclusions.
Risk and Opportunity
1. Risk-based thinking is a new concept with ISO 9001:2015 and refined planning process replaces preventive action. This requires identification of risk and opportunities, planning, and review. There is no requirement to perform a risk assessment but the suggestion to do so is still important. This allows your organization to identify actions to mitigate these risks, review the actions taken and ensure they are effective. Risk identification also encompases preventative actions which is not a requirement but still recommended.
Process Approach
1. Ensure you implement process approach effectively. In ISO 9001: 2015 QMS, process-based management gets more prominence with the identification of processes in the organization. Input, responsibility, authority, accountability, required knowledge, procedure/execution steps, process output, identification of process effectiveness evaluation parameters, monitoring of those parameters/indicators and risks related to the process are all important.
Change Management
1. Changes that affect your product or service quality, customer satisfaction or business performance must be executed under a controlled environment and to ensure you have a planned approach for any changes within your organization.
Suppliers
1. The word “supplier” has been replaced with a new terminology of “External Provider” and includes outsourced processes as well. There is no major change in the compliance of suppliers except the terminology.
External Property
1. External property replaces earlier customer property clause and it now also includes supplier/service provider property along with customer property.
2. This external property to be handled carefully to prevent it from any damage and records to be retained in case it is found unsuitable for use.
3. External property is now replacing customer property clause and includes supplier/service provider property and customer property. External property is to be handled carefully to prevent damage.
Outsourced Process/Service Providers
1. More controls over the effectiveness of outsource service providers are required in the new edition of ISO 9001 because this business process is becoming more prevalent and important within the global manufacturing world.
Leadership
1. The role of leadership and top management has changed in order to incorporate employees of an organization in a more robust and effective way. The term Management Representative is no longer a mandatory position with the intention of having more employees take ownership of the organizational awareness around the management system. Top management (defined as a person or group of people who directs and controls an organization at the highest level) can fulfill this role or delegate this to one or more individuals. Top Management is now expected to take a more hands-on approach to the QMS in order to create awareness for the policy, objectives, communication, processes, risk and opportunity, internal audits, management reviews, and evaluation of QMS effectiveness and efficiency.
Work Environment
1. Within ISO 9001: 2008, physical work was only considered. In the new edition, both social and psychological conditions have been applied to work as well and are considered.
Management Review Meeting
1. Management review meeting become management review. The formal meeting is not always required.

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API Certification: The Step-by-Step Application Guide

11/27/2018

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Where do I begin? Should I hire a consultant? Do I have the time and resources to get my facility certified? How much money will this process take? These are just a few questions that most quality managers and owners ask themselves when deciding on a quality management system standard for their business. This can be a confusing and difficult time for anyone in leadership. Often, this seemingly monumental task leads to inaction on what could be a great business opportunity. Throughout these steps and available resources listed below, I will explain the process of how your oil & gas company can become certified with the American Petroleum Institute to API Q1, API Q2, ISO 9001: 2015, OHSAS 18001, ISO 14001, API Std 18LCM (API Standard 18 for Life-Cycle Management) or an API Monogram product license. Within this guide, you will understand the proper documentation, pricing, and resources to get your organization certified with the most prestigious oil & gas certification body in the world.

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Taking part in the American Petroleum Institute’s Certification Program is one of the most important steps in elevating your oil & gas business to the next level of quality by placing your company on the world stage via the API Composite List.

Currently, there are nearly 5000 certified facilities in over 80 countries worldwide belonging to both the API Monogram and American Petroleum Institute Quality Registrar (APIQR) programs. These companies range from small mom-and-pop shops to large, multinational corporations. While the process is long and seemingly unending, it is entirely possible to become one of these prestigious companies by following this guide.

Questions to Consider Before Applying

The American Petroleum Institute covers many types of standards for specific oil & gas equipment and quality registrations of varying management systems. It is important to understand these categories and how they can help your company when making the decision to apply. Here are a few questions to consider:

Is my facility/company a manufacturer or a service provider?
Are there important environmental or health and safety requirements I want covered under a management system?
What products are my company currently manufacturing? CLICK for a list of API Monogram Licenses.
What products or services would I like my facility to produce in the future?
Does my facility have a validated design package?
What are my suppliers requiring?
What are my customers requesting of me in terms of certifications?
Can I afford to apply for certification? Or more importantly, can I afford not to attain a certification?
Where does my facility currently meet certain industry requirements?

Not only will an API Certification assist your company with global recognition and opportunities in expanding to other markets, these standards are powerful tools in organizing your manufacturing productivity. It may seem like more paperwork but quality management systems can be written in a meaningful and easy-to-use manner that is both beneficial to your company and your customers alike.

Prerequisites to Applying

Listed below are important prerequisites to implement and follow before applying for a certification with API. Timelines are an important component to consider when applying for certification because of audit scheduling and the extra work when implementing a quality system within your business.

Implementation and maintenance of a quality management system that meets the requirements of API Spec Q1, API Q2, OHSAS 18001, ISO 14001, and ISO 9001 for at least four months.
Conducted a full system internal audit to the applicable standard(s) within the past 12 months.
Conducted a management review to the applicable standards within the past 12 months.
Validated design package if applying for a Monogram License.
Own an updated copy of applicable standards. CLICK for subscription or purchasing options.
Completed the proper documentation:
1. Questionnaire (these questions will be listed within the application in MyCerts).
2. Quality Manual written to the applicable standard and its most up-to-date version.
3. Completed Conformity Matrix CLICK.

Quality Consultants for the Oil & Gas Industry
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API Application Timeline:

The application, documentation, and fees are submitted through MyCerts and a quality associate at API reviews the material within 30 days. If the application is accepted, it will be automatically placed in the audit set-up queue. If there are discrepancies within the submitted documentation material, the application will be returned to the applicant with non-conformances or requests for further information. After the application is sent to the audit-setup queue, various local auditors to the facility’s location are contacted in order to coordinate schedules and audit ability. An auditor is chosen and contacts the facility in order to schedule the audit.

MyCerts Application Portal

From application acceptance to the actual facility audit could take from 3-5 months depending on auditor availability. Once the audit is conducted, the facility has 60 days to respond to all findings, if any. Those responses are submitted to a quality associate at API and the associate will have 30 days to review the audit and findings in order to submit this information to the Licensing Registration Committee (LRC) for a seconding review. Once the audit review reaches the LRC they will conduct their review within three business days and either accept or reject the report. If accepted, the facility’s account will be changed to active status within the Composite List and the physical certificates will be mailed within two weeks.

Fees for APIQR
(plus the cost of an audit)

API Q1 - $3,000 for the application fee and $3,000 annual fee once certified.
API Q2 - $3,000 for the application fee and $3,000 annual fee once certified.
ISO 9001: 2015 ed. - $2,000 for the application fee and $2,000 annual fee once certified. ISO 9001 is included with Q1 and Q2 at no additional cost.
ISO 14001 - $2,500 for the application fee and $2,500 annual fee once certified. When included with another registration like API Q1, API Q2, OHSAS 18001 and ISO 9001 the fee for ISO 14001 is only $2,000.
OHSAS 18001 - $2,500 for the application fee and $2,500 annual fee once certified. When included with another registration like API Q1, API Q2, OHSAS 18001 and ISO 9001 the fee for OHSAS 18001 is only $2,000.
API Std 18LCM - $3,000 for the application fee and $3,000 annual fee once certified.

Fees for API Monogram Licensing
(plus the cost of an audit)

1st License - $5,000 for the application fee and $5,000 annual fee once certified.
2nd License - $3,500 for the application fee and $3,500 annual fee once certified.
Each Additional License - $2,000 for the application fee and $2,000 annual fee once certified.

These outlined steps are essential building blocks to becoming an API Certified company which brings immense benefit to you and your business. We hope that this brief outline will assist you in your endeavor to attain a registration or product license in the near future. Feel free to ask us a question either by submitting a comment below or reaching out to us (CLICK).

Now, show your suppliers and future customers around the globe that you meet the API Standards within your manufacturing capabilities!

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