MDSAP Audit Checklist (FDA)

• Site

• Conducted on

  Date

• Prepared by

• Location
  Address

1.1 Quality Management System – Scope

• MDSAP Quality Manual -Section 1

• 1.1.1 Is objective evidence available to demonstrate that each site has defined, planned, and implemented MDSAP QMS quality management system?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 1.1.3 Has each site identified the processes needed to implement MDSAP throughout the organization?

  Yes

  No

  N/A

• 1.1.4 Have criteria and methods been established to ensure that the operation and control of these processes are effective?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 1.1.6 Are processes measured, monitored, and analyzed with appropriate actions taken to achieve planned results and continual improvement?

  Yes

  No

  N/A

1.2 Quality Management System Documented information

• PROCEDURE MDSAP QMS P0002 – Document Control and Approval Procedure
  PROCEDURE MDSAP QMS P0007 – Control of Quality Records Procedure
  PROCEDURE MDSAP QMS P0015 – Naming Convention of Electronic Record Policy
  MDSAP Quality Manual – Section 7.5 Documented information

• 1.2.1 Are documents required for the quality management system properly controlled and managed?

  Yes

  No

  N/A

• 1.2.2 Has each site implemented the MDSAP QMS P0002 in the following aspects:

• a. Developing, reviewing and approving documents for adequacy before they are issued?

  Yes

  No

  N/A

• b. Reviewing, updating as necessary?

  Yes

  No

  N/A

• c. Re-approving changed documents to ensure adequacy prior to use?

  Yes

  No

  N/A

• d. Identifying and maintaining the current revision of documents?

  Yes

  No

  N/A

• e. Ensuring current documents remain legible, readily identifiable and retrievable?

  Yes

  No

  N/A

• f. Identifying and controlling documents of external origin?

  Yes

  No

  N/A

• g. Notifying staff of new, revised or cancelled documents?

  Yes

  No

  N/A

• h. Archiving superseded or obsolete documents?

  Yes

  No

  N/A

• i. Preventing unintended use of obsolete documents retained for any purpose?

  Yes

  No

  N/A

• 1.2.3 Has the established MDSAP Quality Manual been implemented, including:

• a. Scope of quality system, details and exclusion justifications?

  Yes

  No

  N/A

• b. MDSAP QMS Procedures?

  Yes

  No

  N/A

• c. Sequence and interaction of processes or reference to them?

  Yes

  No

  N/A

• 1.2.4 Are records properly managed and controlled?

  Yes

  No

  N/A

• 1.2.5 Has each site implemented the MDSAP QMS P0007 in the following aspects:

• a. Identification?

  Yes

  No

  N/A

• b. Recording and error correction?

  Yes

  No

  N/A

• c. Electronic record identification and back up?

  Yes

  No

  N/A

• d. Access?

  Yes

  No

  N/A

• e. Retention?

  Yes

  No

  N/A

• f. Disposal?

  Yes

  No

  N/A

• g. Archiving?

  Yes

  No

  N/A

• 1.2.6 Do the record control procedures cover reports, correspondence, and technical records, i.e. collection reports, analytical worksheets, equipment data recordings, etc.?

  Yes

  No

  N/A

• 1.2.7 Do record control procedures cover quality records such as procedures, audit reports, corrective action reports, and management reviews?

  Yes

  No

  N/A

2.1 –Leadership and Commitment

• MDSAP Quality Manual – Section 5.1 Leadership and Commitment

• 2.1.1 Has the RAC demonstrated commitment to the QMS development and improvement by:

• a. Communicating to the staff the importance of meeting customer as well as regulatory & legal requirements?

  Yes

  No

  N/A

• b. Communicating the established quality policy and quality objectives?

  Yes

  No

  N/A

• c. Conducting management reviews?

  Yes

  No

  N/A

• d. Ensuring availability of necessary resources?

  Yes

  No

  N/A

2.2 Leadership - Customer Focus

• MDSAP Quality Manual – Leadership - Section 5.1.2 Customer Focus

• 2.2.1 Does top management ensure that customer requirements are determined and met with the goal to achieve customer satisfaction?

  Yes

  No

  N/A

• 2.2.2 Are customers and stakeholders kept informed?

  Yes

  No

  N/A

2.3 Leadership - Policy

• MDSAP Quality Manual – Leadership- Section 5.2 Policy
  MDSAP QMS F0001.1 QMS Policy and Objectives

• 2.3.1 Is there an established quality policy?

  Yes

  No

  N/A

• 2.3.2 Has top management ensured that the quality policy is communicated and understood within each site?

  Yes

  No

  N/A

• 2.3.3 Is the quality policy included in the document control process?

  Yes

  No

  N/A

2.4 Leadership - Responsibility and Authority

• MDSAP Quality Manual – Leadership - Section 5.3 Organizational roles, responsibilities and authorities

• 2.4.1 Are functions and their interrelations within each site defined and communicated?

  Yes

  No

  N/A

• 2.4.2 Are responsibilities and authorities defined?

  Yes

  No

  N/A

• 2.4.3 Is an individual appointed who has the responsibility and authority for ensuring QMS establishment, implementation, and maintenance?

  Yes

  No

  N/A

3.1 Planning - Strategic and Quality Planning

• MDSAP Quality Manual – Section 6. Planning
  MDSAP QMS F0001.1 QMS Policy and Objectives

• 3.1.1 Are there established quality objectives?

  Yes

  No

  N/A

• 3.1.2 Is quality management system planning carried out to meet the requirements of the quality management system and the quality objectives?

  Yes

  No

  N/A

• 3.1.3 If applicable, is there evidence that the integrity of the quality management system is maintained during changes?

  Yes

  No

  N/A

4.1 Support – Resources, Competence and Awareness

• PROCEDURE MDSAP QMS P0014 – Training
  MDSAP Quality Manual – Support – Section 7.1 Resources, Section 7.2 Competence and Section 7.3 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?

  Yes

  No

  N/A

• 4.1.2 Has the MDSAP site available resources to enhance customer satisfaction by meeting customer requirements?

  Yes

  No

  N/A

• 4.1.3 Are personnel performing work affecting quality competent on the basis of appropriate education, training, skills, and experience?

  Yes

  No

  N/A

• 4.1.4 Has the MDSAP site determined the necessary competence for personnel performing activities affecting product quality?

  Yes

  No

  N/A

• 4.1.5 Are personnel who have been assigned QMS responsibilities qualified and deemed competent based on skills, experience, and education & training requirements?

  Yes

  No

  N/A

• If yes, describe how the organization:

• a. Determined the necessary requirements:

• b. Provided training to satisfy competency needs:

• c. Evaluated effectiveness of competence training:

• d. Ensured that personnel are aware of their role in the QMS:

• e. Maintained appropriate records of education, training, skills, and experience:

4.2 Support – Internal Communication

• MDSAP Quality Manual – Support - Section7.4 Communication

• 4.2.1 Is there communication between various levels and functions with respect to the processes of the management system?

  Yes

  No

  N/A

5.1 Operation – Operational planning and control

• MDSAP Quality Manual – Operation, Section 8.1 Operational planning and control<br>MDSAP Audit Procedures and Forms<br>MDSAP Assessment Procedures and Forms<br>MDSAP products and services: Assessment documentation, audit reports and manufacturer certificates

  Yes

  No

  N/A

• 5.1.1 Has the MDSAP site planned and developed the processes needed for their products and services?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

5.2 Operation – Release of Product and Services

• MDSAP Quality Manual – Operation, Section 8.6 Release of products and services
  MDSAP Audit Procedures and Forms
  MDSAP Assessment Procedures and Forms
  MDSAP products and services: Assessment documentation, audit reports and manufacturer certificates

• 5.2.1 Does MDSAP measures and monitors product and services characteristics to verify that product and services requirements have been met?

  Yes

  No

  N/A

• 5.2.2 Is there objective evidence that product and services acceptance criteria have been met?

  Yes

  No

  N/A

• 5.2.3 Do records identify the person authorizing release of the products and services?

  Yes

  No

  N/A

• 5.2.4 Are all specified activities performed before product release and service delivery?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

5.3 Operation – Control of Non-conforming outputs

• PROCEDURE MDSAP QMS P0009 – Nonconformity and Corrective Action
  MDSAP Quality Manual – Operation, Section 8.7 Control of nonconforming outputs

• 5.3.1 Does each MDSAP site- ensure that a non-conforming output is identified and controlled to prevent unintended use or delivery?

  Yes

  No

  N/A

• 5.3.2 Has each MDSAP site implemented the MDSAP QMS P0009 in the following aspects:

• a. Assignment of responsibility for halting work where appropriate and ensuring work resumption upon resolution of non-conformity;

  Yes

  No

  N/A

• b. Making appropriate disposition on a non-conforming output;

  Yes

  No

  N/A

• c. When necessary, notifying the customer of the non-conformance.

  Yes

  No

  N/A

• 5.3.3 Is non-conforming output corrected and subjected to re-verification after correction to demonstrate conformity?

  Yes

  No

  N/A

• 5.3.4 When non-conforming output is detected after delivery or use has started, is appropriate action taken regarding the consequences of the non-conformity?

  Yes

  No

  N/A

6.1 Performance Evaluation and Improvement – General

• MDSAP Quality Manual – Performance Evaluation, Section 9.1.1 General
  PROCEDURE MDSAP QMS P0004 – Risk Management
  PROCEDURE MDSAP QMS P0013 – Continual Improvement

• 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?

  Yes

  No

  N/A

• 6.1.2 Are suitable methods used to measure and monitor these key processes?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

6.2 Performance Evaluation and Improvement – Monitoring, measurement, analysis and evaluation - Customer Satisfaction - Complaints & Feedback

• PROCEDURE MDSAP QMS P0011 – Complaints and/or Customer Feedback
  PROCEDURE MDSAP QMS P0004 – Risk Management
  MDSAP Quality Manual –Performance evaluation – Section 9.1.2 Customer satisfaction

• 6.2.1 Are complaints properly documented, investigated and resolved?

  Yes

  No

  N/A

• 6.2.2 Is feedback other than complaints properly documented and reviewed for opportunities to improve processes, services and work products?

  Yes

  No

  N/A

• 6.2.3 Has each MDSAP site implemented the MDSAP QMS P0011 in the following aspects:

• a. Receiving, documenting and categorizing complaints and feedback about any process, internal or external, that impacts MDSAP components’ processes, services or work products?

  Yes

  No

  N/A

• b. Processing the complaint?

  Yes

  No

  N/A

• c. Determination and investigation of adverse impact?

  Yes

  No

  N/A

• d. For complaints with adverse impact, initiation of corrective action process to resolve the complaint or elevate the issue to the appropriate level for resolution?

  Yes

  No

  N/A

• e. Including complaints/feedback in audits and internal management reviews to ensure that follow-ups were effective in correcting the root causes?

  Yes

  No

  N/A

• f. Review to determine if actions taken in response to complaints or feedback were sufficient and appropriate?

  Yes

  No

  N/A

• g. Closing complaints after corrective action has been completed?

  Yes

  No

  N/A

• 6.2.4 Is complaint data tracked and trended in the CAPA system?

  Yes

  No

  N/A

• Are trending results parts of management review?

  Yes

  No

  N/A

• 6.2.5 Is customer satisfaction information recorded and monitored?

  Yes

  No

  N/A

• 6.2.6 Is customer feedback analyzed for trends and improvements?

  Yes

  No

  N/A

6.3 Performance Evaluation and Improvement – Analysis and Evaluation

• MDSAP Quality Manual – Performance Evaluation, Section 9.1.3 Analysis and Evaluation
  PROCEDURE MDSAP QMS P0013 – Continual Improvement

• 6.3.1 Does MDSAP analyze data to determine the suitability and effectiveness of the quality management system?

  Yes

  No

  N/A

• 6.3.2 Does MDSAP analyze data to identify improvements that can be made?

  Yes

  No

  N/A

• 6.3.3 Does MDSAP analyze data to provide information on customer satisfaction?

  Yes

  No

  N/A

• 6.3.4 Does MDSAP analyze data to provide information on conformance to product and services requirements?

  Yes

  No

  N/A

• 6.3.5 Does MDSAP analyze data to provide information on trends?

  Yes

  No

  N/A

6.4 Performance Evaluation and Improvement - Monitoring, measurement, analysis and evaluation - Internal Assessment/Audit and Continual Improvement

• PROCEDURE MDSAP QMS P0008 – Internal Assessment
  PROCEDURE MDSAP QMS P0013 – Continual Improvement
  PROCEDURE MDSAP QMS P0004 – Risk Management
  MDSAP Quality Manual – Performance Evaluation - Section 9.2 Internal Audit

• 6.4.1 Are internal audits systematically conducted to monitor and determine compliance with the requirements of the MDSAP quality management system?

  Yes

  No

  N/A

• 6.4.2 Has each MDSAP site implemented the MDSAP QMS P0008 in the following aspects:

• a. Implementation of responsibilities for management?

  Yes

  No

  N/A

• b. Implementation of responsibilities by the quality system manager?

  Yes

  No

  N/A

• c. Implementation of responsibilities for auditor?

  Yes

  No

  N/A

• 6.4.3 Are audits carried out by trained and qualified personnel?

  Yes

  No

  N/A

• a. Are audits conducted by people other than those who performed activities being audited?

  Yes

  No

  N/A

• b. Are records of auditor training and/or qualifications maintained and available?

  Yes

  No

  N/A

• 6.4.4 Are audits conducted in accordance with planned scope and schedules, taking into account the results of previous audits?

  Yes

  No

  N/A

• 6.4.5 Are audit findings documented on the appropriate forms and reports, according to documented procedures?

  Yes

  No

  N/A

• 6.4.6 Does management take timely corrective action on deficiencies found during audits?

  Yes

  No

  N/A

• In the event the audit discloses a problem with incorrect procedures or invalid processes, is immediate corrective action taken?

  Yes

  No

  N/A

• 6.4.7 Do follow-ups verify and document corrective action implementation and effectiveness?

  Yes

  No

  N/A

• 6.4.8 Is the final audit report, with resolutions, submitted to management for final approval?

  Yes

  No

  N/A

• 6.4.9 Is the audit closed after final approval of the audit report from management?

  Yes

  No

  N/A

6.5 Performance Evaluation and Improvement - Management Review

• PROCEDURE MDSAP QMS P0005 – Management Responsibility and Management Review
  PROCEDURE MDSAP QMS P0013 – Continual Improvement
  PROCEDURE MDSAP QMS P0004 – Risk Management
  MDSAP Quality Manual –Performance Evaluation - Section 9.3 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?

  Yes

  No

  N/A

• a. Does management review include management as well as the quality system manager?

  Yes

  No

  N/A

• 6.5.2 Do management reviews include at a minimum:

• a. Suitability of policies and procedures?

  Yes

  No

  N/A

• b. Changes that could affect the quality management system?

  Yes

  No

  N/A

• c. Outcome of recent audits?

  Yes

  No

  N/A

• d. Status of corrective and preventive actions and follow-up from prior management reviews?

  Yes

  No

  N/A

• e. Customer complaints/feedback?

  Yes

  No

  N/A

• f. Process performance?

  Yes

  No

  N/A

• g. Product conformity, including product related customer requirements?

  Yes

  No

  N/A

• h. Recommendations and opportunities for improvement?

  Yes

  No

  N/A

• i. Resources and staff training?

  Yes

  No

  N/A

• 6.5.3 Do reviews evaluate the need to change the quality management system, including quality policy and quality objectives?

  Yes

  No

  N/A

• 6.5.4 Are management reviews recorded to include:

• a. Summary of findings;

  Yes

  No

  N/A

• b. Decisions and actions related to improvement of the effectiveness and efficiency of the quality management system and its processes;

  Yes

  No

  N/A

• c. Improvements related to customer requirements;

  Yes

  No

  N/A

• d. Determination of resource needs.

  Yes

  No

  N/A

• 6.5.5 Are management reviews maintained and subsequent actions assigned, planned and monitored to completion?

  Yes

  No

  N/A

6.6 Performance Evaluation and Improvement - Improvement – Nonconformity and Corrective Action

• PROCEDURE MDSAP QMS P0009 – Nonconformity and Corrective Action
  PROCEDURE MDSAP QMS P0013 – Continual Improvement
  PROCEDURE MDSAP QMS P0004 – Risk Management
  MDSAP Quality Manual – Improvement - Section 10.2 Nonconformity and corrective action

• 6.6.1 Does each MDSAP site identify, document, investigate, track and correct the causes of non-conformances?

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

• b. Investigation to examine the extent?

  Yes

  No

  N/A

• c. Determining the root cause of non-conformity to prevent recurrence?

  Yes

  No

  N/A

• d. Determining and implementing corrective actions needed?

  Yes

  No

  N/A

• e. Implementing corrective actions appropriate to the magnitude of the problem?

  Yes

  No

  N/A

• f. Recording results of corrective actions?

  Yes

  No

  N/A

• g. Reviewing corrective actions taken to determine their effectiveness?

  Yes

  No

  N/A

• h. Stopping work if necessary until the non-conformance is addressed?

  Yes

  No

  N/A

• i. Approval of by the initiator’s immediate manager of the correction action?

  Yes

  No

  N/A

• j. Closing the corrective action when there is objective evidence that the action is completed and effective?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 6.6.5 Do procedures ensure relevant information on corrective actions is reviewed during audits and submitted for management review?

  Yes

  No

  N/A

6.7 Performance Evaluation and Improvement - Improvement - Continual Improvement

• PROCEDURE MDSAP QMS P0013 – Continual Improvement<br>MDSAP Quality Manual – Improvement, Section 10.3 Continual Improvement

  Yes

  No

  N/A

• 6.7.1 Is the site engaged in continual improvement of its work products, processes and services according to an established procedure?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• Do data include measuring and monitoring activities?

  Yes

  No

  N/A

• 6.7.3 How are data analyzed to provide information and identify opportunities for improvement on:

• a. Customer satisfaction and/or dissatisfaction?

  Yes

  No

  N/A

• b. Conformance to customer requirements?

  Yes

  No

  N/A

• c. Characteristics of processes, products, and trends of quality characteristics?

  Yes

  No

  N/A

• d. Contractors’ performance?

  Yes

  No

  N/A

• 6.7.4 Is there objective evidence available to demonstrate that the site’s management has created an environment that empowers and encourages staff to actively seek opportunities for improvement of performance in processes, services and products?

  Yes

  No

  N/A

• 6.7.5 Are processes to achieve continual improvement of the quality management system planned and managed?

  Yes

  No

  N/A

• 6.7.6 How is continual improvement of the quality management system facilitated through use of:

• a. Quality policy?

  Yes

  No

  N/A

• b. Quality objectives?

  Yes

  No

  N/A

• c. Internal Audit results?

  Yes

  No

  N/A

• d. Analysis of data?

  Yes

  No

  N/A

• e. Corrective actions?

  Yes

  No

  N/A

• f. Management reviews to include reviews of corrective action reports, audit reports, and customer feedback?

  Yes

  No

  N/A

Completion

• Comments/Recommendations

• Name and signature

  Sign