Developing a common understanding of the way we view Quality Assurance and Quality Control within an EASA Centric World?
Sharing a view - Steve Bentley CEO of Sofema offers his take on how we interpret the terms QA & QC
Introduction - Is there a difference between EASA/FAA & ISO? Interpretation of Quality Assurance & Quality Control?
Well yes but first let's start with this interpretation (not mine) - Quality Glossary Definition: Quality assurance/quality control (QA/QC)
» Quality assurance and quality control are two aspects of quality management.
» While some quality assurance and quality control activities are interrelated, the two are defined differently.
» Typically, QA activities and responsibilities cover virtually all of the quality system in one fashion or another,
» While QC is a subset of the QA activities.
» Also, elements in the quality system might not be specifically covered by QA/QC activities and responsibilities but may involve QA and QC.
So is it clear now?
Well not to me lets take the EASA viewpoint
» QA is the responsibility of the Quality Manager - Independent assessment of the integrity of the entire organization “Compliance with Internal process & Procedures & Compliance with external Regulatory obligations”
» QC is the effective delivery of the organizational process
o Means the Product or
o Service
o To deliver QC the business process must work correctly therefore the owner of the business process (totally NOT the Quality Manager) is responsible for effective delivery
So QC is nothing to do with the Quality Manager?
» Correct - but not we are talking about EASA not FAA & Not ISO
Is the EASA system better?
My contention is yes
o If the business owner is directly responsible for the outcome you have accountability
o If the QA process is totally independent - there is no conflict or vested interest in protecting the assessment
o If QA identifies a shortfall it becomes a finding (corrective action)
o The Business Area Owner is responsible to
» Correct the issue
» Identify why it happened (not just Root Cause but Direct Cause / Contributing Cause & Root Cause)
» Put in place mitigations
o Such behavior is correct because the owner has (or should have) the capacity to fix what they manage / control
Case Study
A well-known Airline employed within the Quality Department two groups of Staff one group called Quality Assurance and the other Group Quality Control
Both QA and QC would perform “audits” and provide findings to the business area owner
» Do you see the difference? - No? - Neither did the business owner who was in-undated with findings from both QA & QC
» What is the purpose of the QC process to simply provide findings (we have QA for this !)
» Such a structure means that the Quality Manager through the QC department is effectively controlling (or trying to control) the business area and in effect, the business own) - source for conflict? - You bet
» When I told the Quality Manager he should relinquish the QC role and “empower” the business area owner, he was aghast!
o Not because he did not agree with my interpretation - rather he saw it as a dilution of his “power”
So Where is QC in an EASA Compliant Organisation?
» Simply it is “embedded” within the organizations delivery process
o Consider the Nominated Person is ultimately “responsible”
» Manpower
» Process
» Procedures
» Standards
» Competence
» Training
» With such a relationship then the organization flourishes, people have the correct understanding of roles of responsibilities
» The business area owner does not have people telling him or her what to do rather what is wrong
» An effective QA system will stand by to provide support and guidance not to attempt to exhibit control
So there is no room for an Independent QC Group
» Of course, there is BUT - it should report to the business area owner so that the role of this group is within the control of the business area.
o In this way the Business Area owner optimizes process and procedures with the support of the QC role - not at their instruction
Quality Control Definition (Again not mine)
Quality control can be defined as "part of quality management focused on fulfilling quality requirements." While quality assurance relates to how a process is performed or how a product is made, quality control is more the inspection aspect of quality management.
Final Comments for EASA (mine)
Please consider that Quality Assurance is all about Compliance with Rules
» External - Regulations
» Internal - Process & Procedures
Please Consider that Quality Control is all about Product or Service Integrity - Delivery to the highest order under the control of the Business Area Owner
Next Steps
Sofema Aviation Services (SAS) www.sassofia.com and Sofema Online (SOL) www.sofemaonline.com provide both regulatory compliant and vocational training related to EASA / FAA /UAE GCAA / OTAR. Please contact team@sassofia.com
