Mdsap audit checklist (fda)
Use this mdsap audit checklist to assess how aligned is the company’s qms with that of mdsap. this digitized mdsap template is based on the us fda’s mdsap qms internal assessment checklist.
What does this form include?
This form contains 50 sections:
MDSAP Quality Manual -Section 1
1.1 Quality Management System – Scope
- 1.1.1 Is objective evidence available to demonstrate that each site has defined, planned, and implemented MDSAP QMS quality management system?
- 1.1.2 Has each site improved the effectiveness of its QMS through the use of quality objectives, audit results, analysis of data, corrective and preventive actions, and management review?
- 1.1.3 Has each site identified the processes needed to implement MDSAP throughout the organization?
- 1.1.4 Have criteria and methods been established to ensure that the operation and control of these processes are effective?
- 1.1.5 Has a quality manager been appointed with defined responsibility and authority for ensuring that the management system related to quality is implemented?
- 1.1.6 Are processes measured, monitored, and analyzed with appropriate actions taken to achieve planned results and continual improvement?
PROCEDURE MDSAP QMS P0002 – Document Control and Approval ProcedurePROCEDURE MDSAP QMS P0007 – Contro
1.2 Quality Management System Documented information
- 1.2.1 Are documents required for the quality management system properly controlled and managed?
1.2.2 Has each site implemented the MDSAP QMS P0002 in the following aspects:
1.2.3 Has the established MDSAP Quality Manual been implemented, including:
1.2.5 Has each site implemented the MDSAP QMS P0007 in the following aspects:
MDSAP Quality Manual – Section 5.1 Leadership and Commitment
2.1.1 Has the RAC demonstrated commitment to the QMS development and improvement by:
2.1 –Leadership and Commitment
- a. Communicating to the staff the importance of meeting customer as well as regulatory & legal requirements?
- b. Communicating the established quality policy and quality objectives?
- c. Conducting management reviews?
- d. Ensuring availability of necessary resources?
MDSAP Quality Manual – Leadership - Section 5.1.2 Customer Focus
2.2 Leadership - Customer Focus
- 2.2.1 Does top management ensure that customer requirements are determined and met with the goal to achieve customer satisfaction?
- 2.2.2 Are customers and stakeholders kept informed?
MDSAP Quality Manual – Leadership- Section 5.2 PolicyMDSAP QMS F0001.1 QMS Policy and Objectives
2.3 Leadership - Policy
- 2.3.1 Is there an established quality policy?
- 2.3.2 Has top management ensured that the quality policy is communicated and understood within each site?
- 2.3.3 Is the quality policy included in the document control process?
MDSAP Quality Manual – Leadership - Section 5.3 Organizational roles, responsibilities and authoritie
2.4 Leadership - Responsibility and Authority
- 2.4.1 Are functions and their interrelations within each site defined and communicated?
- 2.4.2 Are responsibilities and authorities defined?
- 2.4.3 Is an individual appointed who has the responsibility and authority for ensuring QMS establishment, implementation, and maintenance?
MDSAP Quality Manual – Section 6. PlanningMDSAP QMS F0001.1 QMS Policy and Objectives
3.1 Planning - Strategic and Quality Planning
- 3.1.1 Are there established quality objectives?
- 3.1.2 Is quality management system planning carried out to meet the requirements of the quality management system and the quality objectives?
- 3.1.3 If applicable, is there evidence that the integrity of the quality management system is maintained during changes?
PROCEDURE MDSAP QMS P0014 – TrainingMDSAP Quality Manual – Support – Section 7.1 Resources, Section 7
4.1 Support – Resources, Competence and Awareness
- 4.1.1 Is objective evidence available to demonstrate that the MDSAP site has adequate infrastructure needed to implement the quality management system and to maintain its effectiveness?
- 4.1.2 Has the MDSAP site available resources to enhance customer satisfaction by meeting customer requirements?
- 4.1.3 Are personnel performing work affecting quality competent on the basis of appropriate education, training, skills, and experience?
- 4.1.4 Has the MDSAP site determined the necessary competence for personnel performing activities affecting product quality?
- 4.1.5 Are personnel who have been assigned QMS responsibilities qualified and deemed competent based on skills, experience, and education & training requirements?
MDSAP Quality Manual – Support - Section7.4 Communication
4.2 Support – Internal Communication
- 4.2.1 Is there communication between various levels and functions with respect to the processes of the management system?
5.1 Operation – Operational planning and control
- MDSAP Quality Manual – Operation, Section 8.1 Operational planning and controlMDSAP Audit Procedures and FormsMDSAP Assessment Procedures and FormsMDSAP products and services: Assessment documentation, audit reports and manufacturer certificates
- 5.1.1 Has the MDSAP site planned and developed the processes needed for their products and services?
- 5.1.2 Is objective evidence available to demonstrate that the MDSAP site’s management ensures that the MDSAP staff uses defined procedures for performing work, for assuring work is reproducible, and for maintaining information integrity?
MDSAP Quality Manual – Operation, Section 8.6 Release of products and servicesMDSAP Audit Procedures
5.2 Operation – Release of Product and Services
- 5.2.1 Does MDSAP measures and monitors product and services characteristics to verify that product and services requirements have been met?
- 5.2.2 Is there objective evidence that product and services acceptance criteria have been met?
- 5.2.3 Do records identify the person authorizing release of the products and services?
- 5.2.4 Are all specified activities performed before product release and service delivery?
- 5.2.5 If there are instances in which all specified activities have not been performed before product release or service delivery, has a relevant authority, or as appropriate the customer, been informed and approval gained?
PROCEDURE MDSAP QMS P0009 – Nonconformity and Corrective ActionMDSAP Quality Manual – Operation, Sect
5.3 Operation – Control of Non-conforming outputs
- 5.3.1 Does each MDSAP site- ensure that a non-conforming output is identified and controlled to prevent unintended use or delivery?
5.3.2 Has each MDSAP site implemented the MDSAP QMS P0009 in the following aspects:
MDSAP Quality Manual – Performance Evaluation, Section 9.1.1 GeneralPROCEDURE MDSAP QMS P0004 – Risk
6.1 Performance Evaluation and Improvement – General
- 6.1.1 Is objective evidence available to demonstrate that MDSAP has defined, planned, and implemented the monitoring and measurement activities needed to assure conformity and to achieve improvement?
- 6.1.2 Are suitable methods used to measure and monitor these key processes?
- 6.1.3 Are the intended purposes of the key processes quantified by process parameter specifications, by specifications for the product output of the process or by some other means?
PROCEDURE MDSAP QMS P0011 – Complaints and/or Customer FeedbackPROCEDURE MDSAP QMS P0004 – Risk Manag
6.2 Performance Evaluation and Improvement – Monitoring, measurement, analysis and evaluation - Customer Satisfaction - Complaints & Feedback
- 6.2.1 Are complaints properly documented, investigated and resolved?
- 6.2.2 Is feedback other than complaints properly documented and reviewed for opportunities to improve processes, services and work products?
6.2.3 Has each MDSAP site implemented the MDSAP QMS P0011 in the following aspects:
MDSAP Quality Manual – Performance Evaluation, Section 9.1.3 Analysis and EvaluationPROCEDURE MDSAP Q
6.3 Performance Evaluation and Improvement – Analysis and Evaluation
- 6.3.1 Does MDSAP analyze data to determine the suitability and effectiveness of the quality management system?
- 6.3.2 Does MDSAP analyze data to identify improvements that can be made?
- 6.3.3 Does MDSAP analyze data to provide information on customer satisfaction?
- 6.3.4 Does MDSAP analyze data to provide information on conformance to product and services requirements?
- 6.3.5 Does MDSAP analyze data to provide information on trends?
PROCEDURE MDSAP QMS P0008 – Internal AssessmentPROCEDURE MDSAP QMS P0013 – Continual ImprovementPROCE
6.4 Performance Evaluation and Improvement - Monitoring, measurement, analysis and evaluation - Internal Assessment/Audit and Continual Improvement
- 6.4.1 Are internal audits systematically conducted to monitor and determine compliance with the requirements of the MDSAP quality management system?
6.4.2 Has each MDSAP site implemented the MDSAP QMS P0008 in the following aspects:
PROCEDURE MDSAP QMS P0005 – Management Responsibility and Management ReviewPROCEDURE MDSAP QMS P0013
6.5 Performance Evaluation and Improvement - Management Review
- 6.5.1 Does top management review the quality management system at planned intervals (at least annually), to determine the fitness and effectiveness of the quality system in achieving the stated quality objectives?
- a. Does management review include management as well as the quality system manager?
6.5.2 Do management reviews include at a minimum:
6.5.4 Are management reviews recorded to include:
PROCEDURE MDSAP QMS P0009 – Nonconformity and Corrective ActionPROCEDURE MDSAP QMS P0013 – Continual
6.6 Performance Evaluation and Improvement - Improvement – Nonconformity and Corrective Action
- 6.6.1 Does each MDSAP site identify, document, investigate, track and correct the causes of non-conformances?
6.6.2 Has each MDSAP site implemented the MDSAP QMS P0009 in the following aspects:
- a. Identifying non-conformities, including those contained in customer complaints?
- b. Investigation to examine the extent?
- c. Determining the root cause of non-conformity to prevent recurrence?
- d. Determining and implementing corrective actions needed?
- e. Implementing corrective actions appropriate to the magnitude of the problem?
- f. Recording results of corrective actions?
- g. Reviewing corrective actions taken to determine their effectiveness?
- h. Stopping work if necessary until the non-conformance is addressed?
- i. Approval of by the initiator’s immediate manager of the correction action?
- j. Closing the corrective action when there is objective evidence that the action is completed and effective?
- 6.6.3 Do procedures require that processes/services/work products will not be used until the problem is resolved and verified by the appropriate manager and quality system manager?
- 6.6.4 For corrective actions initiated due to complaints, are customers contacted to confirm their concerns have been met prior to closing corrective actions?
- 6.6.5 Do procedures ensure relevant information on corrective actions is reviewed during audits and submitted for management review?
6.7 Performance Evaluation and Improvement - Improvement - Continual Improvement
- PROCEDURE MDSAP QMS P0013 – Continual ImprovementMDSAP Quality Manual – Improvement, Section 10.3 Continual Improvement
- 6.7.1 Is the site engaged in continual improvement of its work products, processes and services according to an established procedure?
- 6.7.2 Analysis of Data: Are appropriate data collected and analyzed to determine quality management system suitability and effectiveness, and to identify possible improvements?
6.7.3 How are data analyzed to provide information and identify opportunities for improvement on:
6.7.6 How is continual improvement of the quality management system facilitated through use of:
Comments/Recommendations
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