SOP for Quality Assurance Policy

 SOP for Quality Assurance Policy

Quality assurance policies are to ensure that routine and continuous quality improvement is an essential, and fundamental part of our organization. Controlling change will aim for continuous improvement in the quality of all aspects of its work as part of its determination to help to get achieve the highest possible standards. 

The objective of this SOP

The objective of the Quality Assurance Policy is to ensure that continuous improvement through a process of self-evaluation and a prepared plan of action. The Quality Assurance Policy and related procedures will be applicable to all employees. The management of the process will be through the existing organisational structure. Respective managers will initiate procedures within their teams and put together and agree on action plans that will help form both individual and corporate development plans of the organisation.

The procedure for Quality assurance policies

The quality assurance procedures will be Prepared on the basis of a process of regular self-evaluation by teams in different departments, internal audits and observations, including employer and client feedback.

The approaches will are seeking for the perspectives and perceptions of beginners and different stakeholders who receive, gain from and choose our training solutions.

Wherever appropriate, the procedures will develop to the identification of quality standards and performance indicators against which performance can be measured, evaluated and upgraded.

Responsibility for Implementation of Quality assurance policies

All the personnel – managers, trainers and helper staff shall be responsible for the implementation of the Quality Assurance Policy.

The Quality assurance Manager is responsible and accountable for an annual review of the policy and also responsible for all to engage positively in that review and ensure implementation.

Quality Assurance policies Focus

To motivate continuous improvement withinside the quality of all personnel training programs and related improvement, making education a recreational activity and through continuous improvement, growing learner retention and the success of learning objectives.

To develop and maintain training programs that will be appropriate across the entire recruitment activity and provide training related to techniques, processes, and structures that will become capable to perform their roles at a higher standard.

Also, provide to collect information and feedback from all interactions with our clients and newly joined personnel that enables continuous updates and improvements to our development solutions.

To develop and establish quality standards and monitoring procedures for providing a supportive and accessible range of services to all newly joined personnel.

The quality assurance department is responsible to review regularly the performance, training, and needs of all employees.

To involve and motivate continual professional development and to conduct the training and development to personnel from Joining, induction, GMP, On Job responsibility, and throughout their employment.

To monitor and evaluate performance and developmental needs through regular one to one reviews and make a training matrix, the same needs to implement as per proposal throughout their employment 

Feedback from customers and stakeholders

Customer feedback will be pursued, reviewed, and execute when relevant to the improvement of the quality of any developmental solution.

Quality assurance needs regular reviews with a customer that will provide feedback that will feed into improvements and changes to our development tools.

The quality of our development programs is dependent on the training of quality policies and applying techniques that we have to educate colleagues and down the team, once they are back in their workplace they will explore, develop, deliver and support a range of processes that will support and encourage learners to apply actions stemming from our development solutions. These initiatives and activities will be regularly reviewed.

  • Quality objectives – The minimum quality standards, which may be set by management, customers, or government regulatory agencies like the FDA.  
  • The quality management system – Includes all policies and procedures to ensure quality requirements are met, including both QA and QC.
  • Quality Assurance: All planned and systematic activities that are designed to ensure quality requirements are met.  
  • Quality Control (QC): Operational activities that are used to verify quality requirements. In most cases, this refers to quality inspections. 
  • Quality Control Audit: An independent examination of your Quality System processes to ensure they are performing as required. Internal audits are done by the company, while external audits are done by an outside agency and regulatory auditors.

The quality plan should include but not be limited to:

An introduction describing the background and need for quality assurance, outlining its scope, activities, and deadlines, as well as quality requirements.

  • Each job title is involved in quality, including responsibilities and required qualifications.
  • An organizational chart showing each role, including external vendors.
  • Document and Data Control
  • Cleaning and Hygiene
  • Supplier standards are required (such as ISO 9001:2015).
  • Process Monitoring
  • Pest Control
  • Personnel Monitory
  • Area Monitoring
  • List of qualified suppliers.
  • Testing parameters, performance standards, and acceptance criteria.
  • Procedures for getting feedback, both internally and from customers.
  • QC procedures.
  • Audit procedures.
  • Training requirements, including job-specific training.
  • Policy on corrective and preventative actions and required notifications.
  • Stability Control
  • Continuous process Improvement-Change Control, Deviation, Failure, Investigation
  • Market Complain and Product recall
  • Risk assessment

MANAGEMENT RESPONSIBILITY

  • Initiate action to prevent the occurrence of work or services of nonconformity.
  • Identify and record any quality problems.
  • Initiate, recommend, or provide solutions.
  • Verify the implementation of solutions.
  • Control further processing, delivery, or installation of non-conforming work until the deficiency or unsatisfactory condition has been corrected.

DOCUMENT CONTROL

  • Document and Data Control procedures are available in all activities where operations essential to the effective functioning of the quality system are performed.
  • All obsolete documents are promptly removed from all points of issue or use

MATERIAL INVENTORY CONTROL

All purchasing documents shall contain data clearly describing the material or services, including where applicable:

  • The type, class, style, grade, or other precise identification of items purchased.
  • The title or other positive identification, and applicable issue dates of specifications, drawings, process requirements, inspection instructions, and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment and personnel.
  • The title, number, and issue of the quality system standard to be applied to the product.
  • The Project Manager shall review and approve purchase documents for adequacy of specified requirements prior to release.

PROCESS CONTROLS

  • SOPs for all activities shall be standardized and clearly mention the procedure of executing the activity to ensure that an acceptable level of quality is maintained at all times. The instructions and procedure shall also specify for equipment, materials, skills, and working environments required to comply with applicable standards, codes, and quality plans.
  • Monitoring and control of the process and work characteristics during the execution of the process.
  • Clear identification of the required approval of processes.

INSPECTION AND TESTING

  • All inspection and testing activities are performed in accordance with the quality plan and documented procedures.
  • Ensure specifications and drawing conformance by the use of established process monitoring and control methods.
  • Ensure that all required inspections and tests have been completed and necessary reports have been received and verified before the finished work is released to the client.
  • Identify and correct any nonconforming work.

CONTROL OF NONCONFORMING ACTIONS AND CORRECTIVE ACTIONS:

Nonconforming: work shall be reviewed in accordance with documented procedures.

The nonconforming work may be:

  • Reworked to meet the specified requirements.
  • Accepted with or without repair
  • Reused for alternative applications
  • Rejected, torn out, scrapped and new work performed.
  • Where required by the contract, the proposed use or repair of the nonconforming work to specified requirements shall be reported for a concession to the client or his representative.
  • The description of nonconformity that has been accepted, and repairs, shall be recorded to denote the actual
    condition.
  • Repaired and reworked work shall be re-inspected in accordance with documented procedures.

Corrective Action: shall establish, document, and maintain procedures for:

  • Investigate the cause of nonconforming work and the corrective action needed to prevent a recurrence.
  • Analyzing all processes, work operations, concessions, quality records, service reports, and customer complaints to detect and eliminate potential causes of nonconforming work.
  • Initiating preventive actions to deal with problems in relation to the risks encountered.
  • Applied controls to ensure that corrective actions are taken and their effectiveness.
  • Implementing and recording changes in procedures resulting from corrective actions

AUDITS

  • Internal Quality Audits. The Quality Unit shall carry out internal audits to verify whether the quality
    activities comply with planned arrangements and to determine the effectiveness of the quality system.

RECORDS

  • To establish procedures for identification, collection, indexing, filing, storage, maintenance, and disposition of quality records.
  • Quality records are to be maintained to demonstrate the achievement of the required quality and the effective operation of the quality system.

TRAINING

  • To identify the training needs of all personnel performing activities affecting quality during the execution of the activity.
  • Personnel performing specific assigned tasks shall be qualified on the basis of appropriate education, training, and experience.
  • Records of training shall be maintained on each individual training.

 

 

 

 

About Abha Maurya

Abha is the Author of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in the pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, and Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008, and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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