Create Your Consulting Invoice for Quality Assurance Effortlessly

Consulting invoice for Quality Assurance

[Music] hi I'm Brian Kerman the chief quality and safety officer at Kerman Consulting and you are watching our video series on ISO 90001 and Quality Management Systems in any operation in our previous episode we discussed what quality is and what it means within a business or operation including development of a quality management system and ISO 901 certification in this episode we are going to explain the structure of a quality management system and how to properly develop a functioning quality program within an operation as part of this explanation we are going to look at the differences between quality control and quality assurance actions within a quality management system throughout this episode I will point out how this all connects to ISO 90001 iso90001 is an internationally recognized voluntary certification program for Quality Management Systems ISO 9001 is not required but is a highly respected standard to which we can Benchmark our discussions on Quality [Music] Systems okay quality management systems are commonly referred to by the acronym qms and quality assurance is commonly referred to to an industry as QA likewise quality control is commonly referred to as QC we will use these designations interchangeably as we unpack their roles and how they all fit together ISO is the name of an independent non-governmental organization which develops International standards called The International Organization for standardization no organization is required to have a quality management system or a quality Department by regulation and many organizations run without a highly structured system in place for achieving correctness in operations furthermore for organizations that choose to implement a qms there is no requirement for development of an ISO 90001 program or to be certified at all that is entirely a business decision lastly a qms does not require a QA or QC department whether or not the company is ISO 901 certified in fact there is no fixed definition for either QA or QC so if either of these are new Concepts that is not problematic even if you are familiar with one or both of these types of departments we will cover Advanced ways to think about these roles and their value in a quality management [Music] system as we stated in our first episode quality is the degree of Excellence found within a service or product product through planning or procedure and a quality management system is the set of people actions interactions and improvements that an organization under goes to achieve that correctness the qms includes organized corrections to errors documented changes and follow-up reviews undertaken to adjust operations and the organization over time so that conditions needed for conforming outputs are properly maintained and altered where necessary for very small organizations the qms tasks may be performed by the person in charge of all decision-making or it may be the person in charge of operations that also addresses the quality management system for mid to large size organizations often a point is reached where the needs of overseeing the quality management system take up so much time and effort that leadership and operations can no longer devote the proper amount of attention to Quality actions while also addressing the other functions of operations such as executive business planning sales finances Human Resources it maintenance and repair it is F this reason that dedicated quality departments exist and one of the immediate benefits of the creation of a quality department is that it can function independently of those other areas of the business that we just mentioned and that independent nature can help keep the focus on quality instead of profit or other business pressures once a business decides to add a quality Department then the responsibility and roles of that department can be defined to include the repeated actions to achieve conforming products and services it is fundamental to note however that the best quality systems establish quality in every aspect of the business and again here we look at executive business planning sales finances Human Resources it maintenance and repair while quality teams act as the guide rails to help focus and maintain the [Music] systems if an organization has determined that a quality management system is necessary for operations and a dedicated quality position or department has been created and empowered to oversee that system we can then start to see the distinction between quality control and quality assurance the simplest way to think about a quality control employee is a line Checker with a clipboard in a Factory or a reviewer of a service call transcript for a service provider where operational employees are responsible for performing the tasks to manufacture a product in a factory the occurrence of errors in production are not often apparent to The Operators themselves QC Personnel or a quality department is responsible for determining how frequently checks of operations and the finished outputs of operation are needed to confirm correctness Q QC need to have knowledge of what the proper checks are that need to take place and identify the equipment and tools that are needed to conduct those checks QC may only require that a person is familiar with the product or service and can visually or audibly confirm that the basic conditions for correctness exist as a result operational employees May convert to a QC role or switch between operations and QC as part of a job the only requ requirement for a properly functioning quality control is that the operational employee cannot perform the quality control check on their own work lastly when we are thinking in terms of an ISO 90001 program there are no specific requirements for quality control actions limits or departments only that the organization can demonstrate effective control during operations and confirmation of correctness is achieved for final products and services effective organizations have a strong understanding of their processes and are able to identify robust quality control parameters to improve their process [Music] control the quality assurance function focuses on systemic processes and therefore quality assurance Personnel are typically tasked with the more advanced project management and documentation tasks of a quality management system or ISO night 2001 program and this would include the creation of schedules and coordinating with internal Personnel in other departments or external stakeholders both the QA tasks and the QC tasks are necessary to confirm correctness of the products and services and we would not ordinarily expect to see a quality control personnel with a clipboard observing the procurement employees purchasing materials for operations as an example this task of observing the procurement employee purchasing materials would be more appropriately assigned to a quality assurance employee or a QA Department quality assurance would be associated with the setting of meetings reviewing maintenance schedules and maintenance records performing traceability or calibration checks for measuring devices overseeing a laboratory performing internal Audits and confirming corrective and preventive actions have been performed properly quality assurance roles are generally more technically demanding and fre quently organizations will require years of specific related work experience and college or Advanced degrees for personnel engaged in QA work and for overseeing QA departments in the context of iso 901 there are not specific requirements for Quality controls however there are required quality assurance actions such as planning risk assessment training internal audit corrective and preventive actions and facilitating management review as a result result it is very common for a company that runs an ISO 9001 compliant program to have a quality assurance [Music] manager with our definitions in place for QA and QC we can immediately see the blurring into one big collection of actions to determine correctness if an employee oversees a laboratory as a lab manager but takes time during the operational day to go out to a processing line to visually inspect products being manufactured they are acting as both QA and QC conversely where a quality control operator reviews service records for a company but is also tasked with setting up trainings for the service team based on the observations of those reviews that person is acting as both QC and QA and it is here that we see a breakdown in the importance of distinction between a quality assurance and Quality Control Function except that the collection of quality assurance and quality control makes up our quality management system some organizations choose to have a quality assurance department and quality control checks are managed by operations and periodically by QA techs that may be out in operational areas other organizations may have a team of qct techs that report directly to upper management and the operations manager or director sets schedules and HR May oversee training in large complex operations designations of a QA department and a QC Department may be present together a good example of a company with a QA and QC Department would be a facility that has multiple production lines where product sampling evaluation and statistical process controls are used to determine conformance to specifications and where a separate testing laboratory is maintained to test incoming and outgoing material as part of operational controls in such a scenario the laboratory manager may take the designation of quality assurance manager and oversee planning functions and trainings while a line check supervisor takes the designation of quality control manager and oversees the inspections sampling and statistical process controls on the [Music] lines the pursuit of quality is a positive role in a business focused on efficiency excellence and Improvement however it's important to be aware that the quality management system itself and the QA QC or combined QA QC Personnel are political actors in an organization they have power biases and may get along with or conflict with other departments as part of their roles this tension may be Amplified for businesses that have chosen to implement an ISO 90001 program program because they have identified a need to pass an ISO 901 certification audit as part of maintaining key business relationships it is crucial that all companies with Quality Management Systems of any configuration have strong organizational leadership strong leadership will ensure that the Quality Personnel or departments are empowered to act independently from the areas of the organization they oversee and do not themselves become a source of conflict or paralysis within the organization which would interfere with quality outputs in our next episode we are going to look at critical quality metrics and key performance indicators as drivers of Quality Management Systems quality control functions and quality assurance functions thank you for watching for more videos please visit our website at cerman consulting or follow us on YouTube [Music]