Quality Assurance and Quality Control...

Quality Assurance and Quality Control  In present day environment, ‘Quality’ is the focus area for the management of every organization for achieving the success. Quality plays a substantial role on the bottom line of the organization. Two terms related to quality that are frequently being used in the Total Quality Management (TQM) and different quality related standards such as ISO 9001 etc. are ‘Quality Assurance’ (QA) and ‘Quality Control’ (QC). Both QA and QC are the part of one circle under quality management techniques. QA concentrates on defect prevention while QC deals with the detection. This is shown in Fig 1. Fig 1 Circle of QA and QC  The terms of QA and QC are closely related to each other. Both the terms also have the same objectives.  In fact both QA and QC complement each other. They are so interlinked and inter-dependent that many persons find it difficult to distinguish them. QA is process oriented and focuses on defect prevention, while QC is product oriented and focuses on defect identification. There exists a lot of confusion in many organizations with respect to these two terms and the activities associated with them. The intended purpose of both QA and QC is to make the product defect free and ensure that it conforms to the requirements of product specifications. In fact both of these terms have got common objective. However the approach to achieve the objective is different. The route followed by both is also different for achievement of the objective. QA still has QC at its core to control the quality of service/product, but it goes beyond mere testing or inspection to also consider related activities or processes (such as training, document control and audits) that may be resulting in defects further down the line. Both QA and QC are essential for an...

Standard Operating Procedures...

Standard Operating Procedures  Standard operating procedure (SOP) is defined as the established or prescribed methods to be followed routinely for the performance of designated operations or in designated situations. It is a document consisting of step by step information on how to execute a task. It is a set of written instructions that document a routine or repetitive activity which is followed by an organization. In a manufacturing organization, an SOP is the step by step production line procedures used to run a process for producing a product as well to train employees. The existence of documented procedures enhances the value of an organization. It shows that the organization is a professional organization which is process driven, rather than top management driven. Process driven organizations create a higher level of confidence amongst the customers. The development and use of SOPs provides individuals with the information to carry out the operations correctly and always in the same manner. By helping to perform a job properly, SOP facilitates in maintaining the quality control and quality assurance processes besides consistency in the quality and integrity of a product or end result. SOPs are intended to be specific to the organization or facility whose activities are described. They describe the activities necessary to complete tasks in accordance with industry regulations, process discipline, local laws or even just organizational own internal standards. The details in an SOP standardize the process and provide step-by-step how-to instructions that enable anyone within the organization to perform the task in a consistent manner. The SOP document serves as an instructional resource that allows employees to act without asking for directions, reassurance, or guidance. The step-by-step written procedure can also help to hold the employees accountable because employee expectations are documented and their actions...

System audits and the process of auditing...

System audits and the process of auditing  System audits are one of the key management tools for achieving the objectives set out in the policy of the organization. A system audit is a disciplined approach to evaluate and improve the effectiveness of a system. Audits are carried out in order to verify that the individual elements within the system are effective and suitable in achieving the stated objectives. The system audit also provides objective evidence concerning the need for the reduction, elimination and most importantly, prevention of non conformities. The results of these audits can be used by the management for improving the performance of the organization. System audits are carried out by the trained auditors who can be organization own staff or staff of an external auditing agency or independent professional auditors. They are carried out by looking up for objective evidence. Definition System audit is defined as “A systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.” System audit is also defined as “A systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.”  Audit objectives  System audits are usually carried out for the following objectives. To evaluate the organization system against a system standard To determine the conformity or non conformity of the system elements with the specified requirements To determine the effectiveness of the implemented system in meeting the specified objectives To offer an opportunity for improvement in the system To meet statutory and regulatory requirements In the latest approach to the systems audit, the auditors are expected to go beyond mere auditing for the compliance by focusing on risk,...