API Q2 Risk Assessment, Contingency Planning & MOC

Inquiry: Where can examples of how to implement API Q2 requirements for risk assessments, contingency planning and management of change be found? Suggestions are appreciated. Maxwell Reply: Hello Maxwell, ISO 31000 can provide some general guidance regarding  risk management terminologies and methods.  However, to fully understand what is actually required to meet API Q2 requirements for risk assessment, contingency planning and management of change (MOC), the best approach would be to consider getting actual hands on experience in these areas by working through individual and group scenarios.  This can be accomplished by attending our next API Q2 training course that (more…)

When Will ISO 9001:2015 Certifications Start To Be Issued?

Inquiry: Our company currently holds dual certifications to API Q1 and ISO 9001:2008 that are not set to expire until November 2017. When making the transition to ISO 9001:2015 and re-certifying in November 2017, will we be able to do dual certifications or will we have to do API Q1 separate from ISO 9001:2015? Thanks! Brian Reply: Hello Brian, in response to your inquiry, the timing for transitioning your existing QMS from ISO 9001:2008 to ISO 9001:2015 is dependent upon your Registrar’s timeline to begin issuing ISO 9001:2015 certifications. I highly recommend that you discuss this subject with your Registrar (more…)

API Q1, Risk Management, Contingency Planning & MOC

In the event of changes that affect the QMS or organizational structure, does API Q1 require a corrective/preventive action to be initiated to document the MOC action? Inquiry: Hi Bill, Firstly, going through the different queries on this site has been very helpful and greatly appreciated, that being said, I have still been in the grey about the whole MOC process. I know that a change in the QMS or organization structure will initiate an MOC but how do I document it? Will a risk assessment suffice? Do I have to initiate a CAPA? Also on another note, can you (more…)

ISO 9001 Audit Deferral – Force Majeure Event

Can An Audit Be Deferred Due To A Force Majeure Event? The following inquiry was received from ASQ Ask the Experts on Apr. 10, 2015: If a Force Majeure event (major storm, flood or other natural event) effects the company during the time that the annual Surveillance Audit was to be done, can the Surveillance Audit be postponed until after the conclusion of the Force Majeure period without losing ISO 9001 certification? Will the impact be 1.) Merely a certificate lapse rectified with passing the re-scheduled Surveillance Audit loss, 2.) Loss of certification requiring the next audit to be a (more…)

API Q2 Fundamentals & Practitioner Training Course

An API Q2 Fundamentals and Practitioner training course will be held in Kingwood TX from May 18, to May 21, 2015. Click this link for course details and access to the registration form. http://tinyurl.com/APIQ2TrainingApr202015 Aston Technical Consulting Services is an API-U Approved Training Provider.  Come join us! (more…)

API Q1 Risk Assessment Conformance

QUESTION: From: Fayyaz Ahmed Sent: Feb. 10, 2015 To: Q-Blog, Ask the Experts Subject: API Q1, clause 5.3, Risk Assessment and Management Fayyez Ahmed asks the following about API Q1: An organization started its transition from API Q1 8th to API Q1 9th edition during September 2013.  They still had not performed risk assessment between June -Nov 2013.  This organization was audited by the API during Jan 2014.  However, API Auditor did not issued an AAR. This organization is going to be audited during 2015, can API Auditor now issue an audit AAR because the organization did not conducted a (more…)

API Q1, Documentation Requirements

QUESTION: From: Jamil K. Sent: Dec. 11, 2014 To: Q-Blog, Ask the Experts Subject: API Q1, clause 4.4.1, sub. e., Documentation Requirements – General Jamil K. asks the following about APIQ1: API Q1, 9th Edition, requires an organization to identify legal and other applicable requirements to which it claims compliance. Please provide any insight as to what kind of items should be considered.  We manufacture manifolds, valves, chokes and control panels in the USA. RESPONSE: From: ATCS QBlog Received: Dec. 12, 2014 Hello Jamil, Thanks for contacting ATCS’s QBlog.  With regard to your question, in my professional opinion the reference (more…)

API Q1, Risk Assessment Requirement

QUESTION: From: Yusri Sent: Aug. 12, 2014 To: Q-Blog, Ask the Experts Subject: API Q1, clause 5.3, Risk Assessment Requirements Yusri asks the following questions about API Q1: API Q1, requires the organization to maintain a documented procedure for risk assessment and management.  What parameters need to be considered for determining risk and their impact on delivery and quality of product?  Should the risk assessment be performed before manufacturing, during manufacturing or after manufacturing? RESPONSE: From: ATCS QBlog Received: Aug. 14, 2014 Hello Yusri, Thanks for contacting ATCS’s QBlog.  With regard to your inquiry, it’s important to know that API (more…)

API Q1, 9th edition – Risks, Contingency Plans and MOC

QUESTION: From: Darcy K. Sent: May 10, 2014 To: ATCS – QBlog, Ask The Experts Subject: API Q1, 9th edition, Risks, Contingency Plans and MOC In regard to MOC Process, in your opinion, would it be effective to tie this into corrective and preventative actions? Any corrective or preventative actions that require changes to the QMS also require MOC, and risk assessment as well and furthermore, tying in any contingency plans that require QMS changes into the corrective and preventative action procedures? RESPONSE: From: Bill Aston, ATCS – QBlog, Ask The Experts Sent: May 13, 2014 To: Darcy K. Subject: (more…)

API Q1, 9th Edition – Critical Supplier

QUESTION: From: Joe St. J., Sent: May 1, 2014 To: ATCS – QBlog, Ask The Experts Subject: API Q1, 9th Edition, Critical Suppliers Joe St. J, asks the following about APIQ1: Hello, Our company remains in the process of transitioning to API Q1, 9th edition. While reading sections 5.6.1.2 and 5.6.1.3, one of our suppliers we purchased materials from for our final product that some of his products we deem as “critical” for our final product and other products as “non-critical“. Under Initial Supplier Evaluation – Critical Purchases, section sub. a states : “Verification that the supplier’s quality management system (more…)

API Q1, 9th Edition – Verification of Proprietary Product vs. Receiving Inspection

Muhammad I. asked the following question: API Q1, 9th edition, clause 5.6.1.2, Section b) and Sub-section iii) requires the organization to verify that supplied product conform to stated requirements when limited by proprietary, legal and/or contractual arrangements. How is this requirement different from – API Q1, 9th edition, clause 5.6.3, which states that “The organization shall ensure and provide evidence that purchased product and activities conform to specified requirements”? Are the specified requirements not the same as proprietary, legal and/or contractual arrangements? ATCS RESPONSE: Hello Muhammad, The requirements of API Q1, 9th edition, 5.6.3, are entirely different from those requirements (more…)

API Q1, 9th Ed., Quality Policy vs. Objectives

QUESTION: From: T.S. , Tercel Oilfield Sent: Jan. 20, 2014 To: ATCS – QBlog, Ask The Experts Subject: API Q1, 9th Ed., Quality policy and Objectives Am I correct in saying that Objectives should establish the highest overall expectation and direction of the Top Management and that S.M.A.R.T. Goals should then established by the different departments and personnel that are in support of achievement of the Objective? For instance, each department can have their own yet different Smart Goals but all the Goals should be designed to help the department or employees achieve the Objective established by Top Management?  For (more…)