SKILL DEVELOPMENT TRAINING INTERNSHIP REPORT I n t e r n a t i o na l R e q u i r e m e n ts no good M a n u f a ctu r i ng P r a ct i c e s
GMP FOR STANDARD MANAGEMENT FOR QUALITY SYSTEM Prepared by LAVANYA D asper205c22ug205che033 5 th Semester OCTOPER,2024 205 K A V E RY A R T S & S C I E N C E C O LL E G E PERIYAR UNIVERSITY
INTERNSHIP REPORT CONTENT: Standard operating procedure for Quality system Prepare Validation protocol and report for equipment/utilities flow chart for quality attributes Project Quality Risk Management as per Process flow Prepare Internal Audit report
Standard operating procedure for Quality system DEFINITION; Standard operating procedures or SOPs are written step- by-step procedures that quality control (QC), quality assurance (QA), and production units use in order to assure the accuracy and precision of the quantitative experimental results and materials that they generate and provide in support of other units.
Standard operating procedures(SOP); 5 Essentials for Every SOP; Keep a Clear User Viewpoint. You should always be thinking about your end user when you write an SOP. ... Format Clearly. As well as being careful with language, process documentation should always use intuitive formatting. ... Keep Scope in Mind. ... Observe Roles and Impacts. ... Seek Authority and Approval.
Quality Management System DEFINITION; ISO 9001 is a standard that defines the requirements for a Quality Management System (QMS) . It helps businesses and organizations be more efficient and improve customer satisfaction. The primary focus of the ISO 9001 standard is to meet customer requirements and strive to exceed customer expectations .
BENEFIT OF STANDARD OPERATING PROCEDURES Business-growing steps are outlined clearly so that the entire team can establish a routine to help scale. Without needing higher-up approval on every action, overall organization productivity, efficiency, and time-saving get a major boost. Onboarding new employees, contractors, and customers are done quickly, so those experiencing the organization both internally and externally have a positive and valuable experience. Reoccurring tasks can be mapped out, freeing up mental space and streamlining any sort of process, from onboarding to content management. An organization can deliver consistent results across the board, which builds client trust and a good reputation. The entire team does not end up relying on one particular person to make decisions and develop processes. SOPs ensure compliance and safety of the entire team when everybody abides by the same rules and no two people complete the same task in a vastly different way.
Disadvantages to (SOP); Potential Drawbacks Lack of Flexibility: SOPs can sometimes be too rigid, limiting employees' ability to adapt to unexpected situations or innovate. Time-Consuming Development: Creating detailed SOPs can be time-consuming and resource-intensive, especially for smaller businesses with limited staff. Resistance to Change: Employees may resist following new SOPs, particularly if they feel the procedures are unnecessary or overly complex.