Consequence-of-SOP-and-training-records-during-audit

Introduction 

Ultimately, every person in a company is accountable for the quality of its products and services. 

company can best achieve its business purposes by establishing and managing robust quality systems with their essential quality documents including standard operating procedures (SOPs)and top management should provide the training and suitable encouraging environment to foster teamwork both within and across organizational units for employees to improve entireprocesses. 

It is binding for all organizations alike to establish, manage and monitor their entire controlled systems through integral standard operating procedures (SOP), training and other quality documents to provide high-quality products and services to fully satisfy expectations during any kind of regulatory auditor demand to ensure processes and involved stack holders are enougheducated to handle the system. 

Entire organization systems together constitute the key quality systems focused on fulfilling quality requirements, whereas quality assurance is focused on providing confidence that quality requirements are fulfilled. The quality systems must be appropriate with the company business objectives and business model. Effective and resourceful quality systems can promote timely registration of drugs by eliminating reprocess or rework and reduced waste with overall financial and productivity benefits to the company. 

Interlinking between SOP and training 

Generally, the SOP consists of the scope of process of establishing, agreement and approved by a nominated hierarchy body and they provide for use, rules, guidelines or characteristics for activities or their results with a view to promote transparency, consistency, reproducibility, interchangeability and to facilitate communication and implementing standards through provide effective training to the involved stockholder to evaluate process robustness. Therefore, standards are the ultimate result of a standardization activity and within the context of quality systems consist of quality documents or training related to the quality systems. 

Meanwhile, whole manually activity to become very crucial job for all employee at the time of represent data in front of auditor because SOP must be either subject to regulations or it must address a task important within process quality systems or between training systems and other functional units. Functional, operational and quality systems related SOPs should generallycover the following topics in order to capture the core functional team activities and processes: 

Definition, format, content, compilation, indexing, annexure, format, review, approval, training, effectiveness, versioning control, distribution and archiving and revision of SOP and again follow up same procedure and same paper documents repository in storage area. Finally, shredding and incinerating of record procedure also painful. 

While on the other hand every employee must have been initiation and maintenance manually document of personnel training records files including content of curriculum vitae, job description, training records and personal and professional development plan, certificates for the quality prospective and always readiness for auditing purpose anytime. Finally, left or absconded employee file has been stored up to product life cycle may lead hectic pressure with routine job. 

While preparation of sites for regulatory inspections or coordination and management of regulatory inspections organization need to maintain with quality management system including SOP management, education and training and auditing, document management system including archives, data management.  

Benefits of Doc control & TMS System 

The significance of properly established and managed with integral well-written SOPs and other quality documents with effective measurement of training for the achievement of company business objectives cannot be ignored and SOP effectiveness and training imparting are very corelative subject for life science industries. They serve as a permit to success by assisting thecompany to achieve high-quality processes, procedures, systems, and people, with eventual products and services and enhancement of the following: 

  • Customer satisfaction, and therefore, customer constancy and repeat business andrecommendation 
  • Timely registration of drugs by eliminating waste and the no need for rework, 
  • Operational results such as revenue and profitability, 
  • Alignment of processes with achievement of better process quality results, 
  • Understanding and inspiration of employees toward the company quality policy and business points 
  • Actively participate in continual productivity and quality improvement initiatives,  

Conclusion: 

Quantum levels of quality are essential to achieve company business objectives. Quality, a source of competitive advantage, should remain a symbol of company products and services. It is an essential basic requirement. Quality does not only relate only to the end products and services company provides but also relates to the way the company employees to do their job and the work processes they follow to produce products or services. Though “QEdge” provide to the client very enormous solution for “SOP/Doc management” and Training management”processes should be as efficient as possible and continually improving according to compliance of various guideline. Our powerful and easy processing solution for both concern SOP life cycle as well as training management throughout involved employees and organization constitute the most important resource for improving quality. Each employee in all organizational units is responsible for ensuring that their work processes are efficient and continually improving.