Professional Documents
Culture Documents
Audit Date: Audit Description: Lead Auditor: Audit Team Members (if applicable): This Audit Checklist is based on the following Standards / Directives/Regulations: 21 CFR 820 (EN) ISO 13485:2003 (Medical Devices: Quality Management Systems Requirements for regulatory purpose); In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC
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4.2.1 Documentation Requirements General 5.3 Quality Policy 5.6.1 Management Review General 6.3 Infrastructure 7.3.1 Design and Development Planning 7.3.7 Control of Design and Development Changes 7.5.2.1 Validation of processes for Production and Service Provision-General 7.6 Control of Monitoring and Measuring Devices 8.3 Control of Nonconforming Product
4.2.3 Control of Documents 5.4.2 Quality Management System Planning 5.6.3 Review Output 7.1 Planning of Product Realization 7.3.3 Design and Development Outputs 7.4.2 Purchasing Information
4.2.4 Control of Records 5.5.1 Responsibility and Authority 6.1 Resource Management Provision of Resources 7.2.1 Determination of Requirements 7.3.4 Design and Development Review 7.4.3 Verification of Purchased Product 7.5.3.3 Status Identification
5.1 Management Commitment 5.5.2 Management Representative 6.2.1 Human Resources General 7.2.2 Review of Requirements Related to the Product 7.3.5 Design and Development Verification 7.5.1.1 Control of Production and Service Provision-General 7.5.4 Customer Property 8.2.3 Monitoring and Measurement of Processes 8.5.3 Preventive Action
6.4 Work Environment 7.3.2 Design and Development Inputs 7.4.1 Purchasing Process
7.5.3.1 Identification 8.1 Measurement, Analysis and Improvement-General 8.4 Analysis of Data
7.5.3.2 Traceability 8.2 Monitoring and Measurement Customer Feedback 8.5.1 ImprovementGeneral
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ISO 9001:2000 ISO 13485:2003 Q# 21 CFR 820 Audit Questions 4 Quality Management System 4.1 General Requirements 820.25 Quality System
4.1q1 Has Organization established, documented, implemented and maintained a QMS and maintained (and continually improved) its effectiveness in accordance with ISO 9001/13485 and 21 CFR 820? (Questions in section 4.1 are verified throughout the audit) Where has Organization identified the processes needed for the QMS and their application throughout the organization? (See 4.2.2) Where has Organization determined the sequence and interaction of QMS processes? (See 4.2.2) What are the criteria and methods Organization uses to ensure that the operation and control of QMS processes are effective?
Finding? Level?
(C = Critical NC, M = Major NC, R = Minor NC)
4.1q2
4.1q3
4.1q4
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4.1q5
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NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.
4.2.1q2 4.2.1q3
4.2.1q4
4.2.1q5 4.2.1q6
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4.2.1q7
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4.2.1q11
4.2.1q12
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4.2.1q14
recall / vigilance system incident reporting market complaints traceability of sold devices training spare parts technical documentation
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NOTE 1 Where the term documented procedure appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to a) the size of organization and type of activities, b) the complexity of processes and their interactions, and c) the competence of personnel. NOTE 3 The documentation can be in any form or type of medium.
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ISO 9001:2000 ISO 13485:2003 Q# 21 CFR 820 Audit Questions 4.2.3 Control of Documents 820.40 Document Controls
4.2.3q1 How are the documents required by the QMS controlled? (Documents to be reviewed throughout the audit) 4.2.3q2 Can you show me a procedure that defines the controls needed for each of the following? - review and approve documents for adequacy prior to issue? - review and update as necessary and reapprove documents? - ensure that changes and the current revision status of documents are identified? - ensure that approved changes are communicated to personnel in a timely manner? - ensure that relevant versions of applicable documents are available at points of use? - ensure that documents remain legible and readily identifiable? - ensure that documents of external origin are identified and their distribution controlled?
Auditor Name (print): Pages may be used independently.
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4.2.4q2
4.2.4q3
4.2.4q4
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ISO 9001:2000 ISO 13485:2003 Q# 21 CFR 820 Audit Questions 4.2.4 Control of Records 820.181 Device Master Record (DMR)
4.2.4q5 Does the company maintain device master records including or referencing the following information: - device specifications such as drawings, composition, formulation, component specifications, software specifications, - production process specifications including or referencing the following: equipment specifications, production methods and procedures and production environmental specifications - quality assurance procedures and specifications including acceptance criteria and quality assurance equipment to be used - packaging and labeling specifications including methods and process used - installation, maintenance and servicing procedures and methods
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ISO 9001:2000 ISO 13485:2003 Q# 21 CFR 820 Audit Questions 4.2.4 Control of Records 820.184 Device History Record (DHR)
4.2.4q6 Does the company maintain device history records for each batch, lot unit in accordance with the DMR? The DHR should include: - dates of manufacture - quantity manufactured - quantity released to distribution - acceptance records - primary identification label - labeling used for each production unit - device identification and control number used
4.2.4q8
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ISO 9001:2000 ISO 13485:2003 Q# 21 CFR 820 Audit Questions 5 Management Responsibility 5.1 Management commitment 820.20 Management responsibility
5.1q1 How does top management communicate the importance of meeting customer and legal requirements to the organization? Has a company quality policy been established? (See 5.3) What are the quality objectives established by top management? (See 5.4.1) Does top management conduct management reviews? (See 5.6) How does top management ensure the availability of resources to support and continually improve the QMS?
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ISO 9001:2000 ISO 13485:2003 Q# 21 CFR 820 Audit Questions 5.3 Quality Policy 820.20 Management responsibility
5.3q1 How does top management ensure that the quality policy is appropriate to the purpose of the organization? Does the quality policy include a commitment to comply with requirements and to maintain (continually improve) QMS effectiveness? Are the contents of the quality policy relevant to Organization, and measurable? Is the quality policy communicated and understood within the organization? Is there an established process to review the quality policy for continuing suitability?
5.3q2
5.3q3
5.3q4 5.3q5
5.4 Planning
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ISO 9001:2000 ISO 13485:2003 Q# 21 CFR 820 Audit Questions 5.4.1 Quality Objectives 820.20 Management Responsibility
5.4.1q1 Has top management established quality objectives (including those needed to meet requirements for product) at relevant functions and levels within the organization? Are the quality objectives consistent with the quality policy? What are the measurements?
5.4.1q2
5.4.2q2
5.4.2q3
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ISO 9001:2000 ISO 13485:2003 Q# 21 CFR 820 Audit Questions 5.5.1 Responsibility and authority 820.20 Management responsibility
5.5.1q1 How are responsibilities and authorities defined, documented and communicated within the organization? (Verify throughout audit) Are procedures and responsibilities defined and documented to notify the representative for medical devicerelated safety issues to the respective competent authority
5.5.1q2
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ISO 9001:2000 ISO 13485:2003 Q# 21 CFR 820 Audit Questions 5.5.2 Management representative 820.20 Management responsibility
5.5.2q1 Has your Management Representative been defined? Does the management representative have responsibility and authority to: - ensure that processes needed for the QMS are established, implemented and maintained? - report to top management on the performance of the QMS and any need for improvement? - ensure the promotion of awareness of regulatory and customer requirements throughout the organization?
NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.
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ISO 9001:2000 ISO 13485:2003 Q# 21 CFR 820 Audit Questions 5.6.1 General 820.20 Management Responsibility
5.6.1q1 What is the frequency that top management reviews the organization's QMS? What kinds of information are reviewed in management reviews? (must include suitability, adequacy and effectiveness of QMS; improvement; & changes to the QMS, quality policy and objectives) Can you show me records from recent management reviews?
5.6.1q2
5.6.1q3
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ISO 9001:2000 ISO 13485:2003 Q# 21 CFR 820 Audit Questions 5.6.2 Review input 820.20 Management responsibility
5.6.2q1 Can you show me that each of the following were included in review(s)? - results of audits, - customer feedback, - process performance and product conformity, - status of preventive and corrective actions, - follow-up actions from previous management reviews, - changes that could affect the quality management system, - recommendations for improvement, and - new or revised regulatory requirements.
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ISO 9001:2000 ISO 13485:2003 Q# 21 CFR 820 Audit Questions 5.6.3 Review Output 820.20 Management responsibility
5.6.3q1 What decisions or actions have resulted from management reviews for each of the following? - improvement needed to maintain the effectiveness of the quality management system and its processes, - improvement of product related to customer requirements, and - resource needs
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ISO 9001:2000 ISO 13485:2003 Q# 21 CFR 820 Audit Questions 6.2.1 General 820.20 Management responsibility
6.2.1q1 Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience. What are the education, training, skills and experience required by this job/task? How does this person meet those qualifications?
6.2.2q2
6.2.2q3
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6.2.2q4 6.2.2q5
NOTE National or regional regulations might require the organization to establish documented procedures for identifying training needs.
6.3q2
6.3q3
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ISO 9001:2000 ISO 13485:2003 Q# 21 CFR 820 Audit Questions 6.4 Work environment 820.70 Production and process controls
6.4q1 Are procedures and responsibilities defined and documented for health, cleanliness and clothing of personnel, if contact between such personnel and product or environment could adversely affect the quality of product? Are the personnel who are supposed to work part time under specific environmental conditions appropriately trained or supervised by trained personnel? Are requirements for the environment to which products are exposed documented and maintained (if appropriate, the environmental conditions shall be controlled and/or monitored, e.g. bio-burden)?
6.4q2
6.4q3
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ISO 9001:2000 ISO 13485:2003 Q# 21 CFR 820 Audit Questions 7 Product Realization 7.1 Planning of product realization 820.5 Quality System
7.1q1 Where in the product realization process do you determine the quality objectives and requirements for products? When planning for product realization, how do you establish processes, documents, and provide resources specific to the product? How do you determine verification, validation, monitoring, inspection and test activities specific to the product, and the criteria for product acceptance? What records exist showing that both the realization processes and the product meet requirements? What are the outputs of product realization planning? Are they in a form suitable for Organization? Where are the requirements for risk management documented?
7.1q2
7.1q3
7.1q4
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7.1q6
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NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan. NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes. NOTE 3 See ISO 14971 for guidance related to risk management.
7.2 Customer-related processes 7.2.1 Determination of requirements related to the product 820.30(c) Design Inputs
7.2.1q1 How does Organization determine each of the following requirements? - requirements specified by the customer, including the requirements for delivery and post-delivery activities, - requirements not stated by the customer but necessary for specified or intended use, where known, - statutory and regulatory requirements related to the product, and - any additional requirements determined by the organization.
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7.2.2q2
7.2.2q3
7.2.2q4
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NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material
7.3 Design and development 7.3.1 Design and development planning 820.30 Design controls
7.3.1q1 Are documented procedures for design and development established?
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7.3.1q2
7.3.1q3 7.3.1q4
7.3.1q8
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NOTE Design transfer activities during the design and development process ensure that design and development outputs are verified as suitable for manufacturing before becoming final production specifications.
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ISO 9001:2000 ISO 13485:2003 Q# 21 CFR 820 Audit Questions 7.3.2 Design and development inputs 820.30(c) Design input
7.3.2q1 What are the design inputs relating to each of the following product requirements? - functional, performance and safety requirements, according to the intended use, - applicable statutory and regulatory requirements, - where applicable, information derived from previous similar designs, and - other requirements essential for design and development, and - output(s) of risk management. Where are they recorded? 7.3.2q2 How & when are the design and development inputs reviewed and approved for adequacy? How does Organization ensure that requirements are complete, unambiguous and dont conflict with each other?
7.3.2q3
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ISO 9001:2000 ISO 13485:2003 Q# 21 CFR 820 Audit Questions 7.3.3 Design and development outputs 820.30(d) Design output
7.3.3q1 How can design and development outputs be verified against the inputs? (see 7.3.5q1) Are these outputs approved prior to release? Can you show me examples of design and development outputs and how they meet the input requirements? What outputs include information for purchasing, production and service? Where are product acceptance criteria specified? Where are product characteristics needed for safe and proper use specified? 7.3.3q3 Does labeling for Medical Devices comply with regulatory requirements (e.g. EU directives, CMDR, FDA)? - Name of Device, Identifier - Name and address of manufacturer - Expiry date (if applicable) - CE (only EU) etc.
7.3.3q2
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7.3.3q4
NOTE Records of design and development outputs can include specifications, manufacturing procedures, engineering drawings, and engineering or research logbooks.
7.3.3q5 7.3.3q6
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ISO 9001:2000 ISO 13485:2003 Q# 21 CFR 820 Audit Questions 7.3.4 Design and development review 820.30(e) Design review
7.3.4q1 At what stages of design and development do you perform reviews to evaluate if the results meet requirements? (See 7.3.1q2b) Can you show me some problems that have been identified and actions proposed at these reviews? 7.3.4q2 What functions (including specialists) are represented at these reviews? At each stage, are all functions concerned with that stage represented? 7.3.4q3 Does an independent reviewer participate and approve each design and development stage? Can you show me records of the results of the reviews and any necessary actions taken? Are the records of design review and any actions taken documented in the DHF?
7.3.4q4
7.3.34q5
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ISO 9001:2000 ISO 13485:2003 Q# 21 CFR 820 Audit Questions 7.3.5 Design and development verification 820.30(f) Design verification
7.3.5q1 What verification activities are performed to ensure that the design and development outputs have met the input requirements? (See 7.3.3q1) Can you show me records of the results of the verification activities and resulting actions? Are design verification records contained or referenced in the DHF?
7.3.5q2
7.3.5q3
7.3.6q2
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7.3.6q4
Can you show me records of the validation activity results and any follow-up actions? Are design validation records contained or referenced in the DHF? Are procedures and responsibilities defined and documented to perform and evaluate clinical investigation / clinical trials? Are records about clinical data evaluation and / or testing part of the design documentation? Are they maintained? Updated? Are procedures and responsibilities defined to select and evaluate scientific literature used for the clinical evaluation?
7.3.6q5 7.3.6q6
7.3.6q7
7.3.6q8
NOTE 1 If a medical device can only be validated following assembly and installation at point of use, delivery is not considered to be complete until the product has been formally transferred to the customer. NOTE 2 Provision of the medical device for purposes of clinical evaluations and/or evaluation of performance is not considered to be delivery.
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7.3.7q4
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ISO 9001:2000 ISO 13485:2003 Q# 21 CFR 820 Audit Questions 7.4.1 Purchasing controls 820.50 Purchasing controls
7.4.1q1 How do you ensure that purchased product conforms to specified requirements? Can you show me a procedure for this? 7.4.1q2 How do you determine the type and extent of control applied to the supplier and the purchased product? How do you evaluate and select suppliers? (based on their ability to supply product in accordance with Organizations requirements) Can you show me the criteria for selection, evaluation and re-evaluation of suppliers? Can you show me records of the results of supplier evaluations and any necessary actions? (verify that criteria have been met) Is there a record of acceptable suppliers, contractors and consultants? How is it maintained?
7.4.1q3
7.4.1q4 7.4.1q5
7.4.1q6
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ISO 9001:2000 ISO 13485:2003 Q# 21 CFR 820 Audit Questions 7.4.2 Purchasing information 820.50 Purchasing controls
7.4.2q1 Do orders/contracts include requirements for approval of product, procedures, processes and equipment? Do require any qualification of supplier personnel? If so, can you show where the requirement is documented? 7.4.2q2 Do you have any QMS requirements of your suppliers? If so, can you show me where they are required? How does Organization ensure the adequacy of purchasing requirements before communicating them to the supplier? Can you show me records of orders and and/or contracts?
7.4.2q3
7.4.2q4
7.4.3 Verification of purchased product 820.80 Receiving, in-process and finished device acceptance
7.4.3q1 What inspection or other activities are used to ensure that incoming purchased product meets your purchasing requirements?
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7.5 Production and service provision 7.5.1 Control of production and service provision 7.5.1.1 General requirements
7.5.1.1q1 When carrying out production (or service) are all of the following controlled conditions in place? - Is information that describes the characteristics of the product available? - Are appropriate documented procedures, documented requirements, work instructions, reference materials and reference measurement procedures available (if needed)? - Is suitable equipment used for carrying out production (or service)? - Are appropriate monitoring and measuring instruments used in production
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7.5.1.1q2 7.5.1.1q3
Are processes and process equipment approved? Can you show me batch records for a device?
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7.5.1.2.1q3
7.5.1.2.2 Installation activities 820.170 Installation 7.5.1.2.2q1 Are there documented requirements with acceptance criteria for installing and verifying the installation? Are there documented requirements for installation and verification if installation is performed by an outside organization? Can you show me records of installation and verification?
7.5.1.2.2q2
7.5.1.2.3q3
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7.5.1.2.3 Servicing activities 820.200 Servicing 7.5.1.2.3q1 Are there documented procedures, work instructions, reference materials and reference measurement procedures? Are there records of servicing activities?
7.5.1.2.3q2
7.5.2 Validation of processes for production and service provision 7.5.2.1 General requirements 820.75 Process validation
7.5.2.1q1 Do you have any production or service processes where the resulting output cannot be verified later? If so, how to you validate them? 7.5.2.1q2 Can you show me records that demonstrate that the validation done has met the requirements? How are these process validations reviewed and approved? Can you show me records of personnel and equipment qualification?
7.5.2.1q3 7.5.2.1q4
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7.5.2.1q5 7.5.2.1q6 7.5.2.1q7 7.5.2.1q8 7.5.2.1q9
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NOTE In some industry sectors, configuration management is a means by which identification and traceability (are) can be maintained.
7.5.3.3q2
7.5.3.3q3
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7.5.4q3
NOTE Customer property can include intellectual property or confidential health information.
7.5.5 Preservation of product 820.150 Storage 820.130 Device packaging 820.140 Handling 820.160 Distribution
7.5.5q1 How do you preserve the conformity of product during internal processing and delivery? (Verify product throughout audit) Can you show me work instructions or procedures for this? 7.5.5q2 Are there procedures or work instructions for control of storage areas and stock rooms for product to prevent mixups, damage, deterioration, contamination or other adverse effects pending use or distribution?
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7.6 Control of monitoring and measuring device 820.72 Inspection, measuring and test equipment
7.6q1 How do you determine the measurements to be taken and the measuring equipment needed to demonstrate conformity of product with requirements? What process is in place to ensure that measurements are taken per the requirements? Can you show me procedures for this?
7.6q2
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7.6q6 7.6q7
NOTE See ISO 10012-1 and ISO 10012-2 for guidance related to measurement management systems.
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8.1q2
8.1q3 8.1q4
Are sampling plans, when used, written and based on valid statistical rationale? Are there procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed?
NOTE National or regional regulations might require documented procedures for implementation and control of the application of statistical techniques.
8.2 Monitoring and feedback 8.2.1 (Customer satisfaction) Feedback 820.198 Complaint files
8.2.1q1 How do you obtain information about (customer perception as to) whether Organization has met customer requirements? How is this information used?
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8.2.1q2
8.2.1q3 8.2.1q4
8.2.1q5
If a complaint is a reportable event are the documents maintained separately portion of the complaint files or otherwise clearly identified? Are records of all customer complaint investigations maintained? Are complaint records readily available?
8.2.1q6 8.2.1q7
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8.2.1q9
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ISO 9001:2000 ISO 13485:2003 Q# 21 CFR 820 Audit Questions 8.2.2 Internal audit 820.22 Quality audit
8.2.2q1 Are internal audits being conducted at planned intervals? Do they determine whether the QMS conforms to the requirements of ISO 9001, ISO 13485 and 21CFR 820 and to the other requirements established by Organization? (Review records to demonstrate conformance) Do they determine whether the QMS is effectively implemented and maintained? (Review records) 8.2.2q2 Can you show me an audit plan that takes into consideration the importance of the processes and areas to be audited, and the results of previous audits? Where are the audit criteria, scope, frequency and methods defined? Can you demonstrate that selection of auditors and the conduct of audits are objective and impartial, and that auditors dont audit their own work?
8.22q3 8.2.2q4
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8.2.2q5
8.2.2q6
Who ensures that actions are taken to eliminate detected nonconformities and their causes? Are they being taken care of in a timely manner? (verify with records) What activities are done to verify the actions taken, and how are the verification results reported?
8.2.2q7
NOTE See ISO (10011-1, ISO 10011-2 and ISO 10011-3) 19011 for guidance related to quality auditing.
8.2.3 Monitoring and measurement of processes 820.70 Production and process controls
8.2.3q1 8.2.3q2 What methods are used to monitor and measure the QMS processes? Can you show that they have achieved the desired results?
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8.2.3q3
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8.2.4 Monitoring and measurement of product 8.2.4.1 General requirements 820.80 Receiving, in-process and finished device acceptance
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8.2.4.1q1 8.2.4.1q2
8.2.4.1q3 8.2.4.1q4
How is evidence of conformity with acceptance criteria maintained? Can you show me records that indicate who has authorized release of product to the next stage of the process? Is final product acceptance documented in the DHR? How do you ensure that product is not released until the all requirements have been met? If product must be released prior to this, how is it approved?
8.2.4.1q5
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8.3q1
8.3q2
Can you show me a procedure defining the controls for dealing with nonconforming product? Does it show responsibilities/authorities?
When you have nonconforming product, what methods do you use to deal with it? Can you show me records of the identity of personnel authorizing concessions? Can you show me records of nonconforming material and any actions taken? Are there any records of concessions obtained? When nonconforming product is corrected, can you demonstrate that it is re-verified to ensure it conforms to requirements?
8.3q6
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8.3q7
8.3q8
Can you show me rework procedures or work instructions approved by same authority as the original work instruction? Can you show me records of determination of adverse effects of rework? Was the determination made prior to authorization of the work instruction? Are rework records documented in the DHR?
8.3q9
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8.4q1
8.4q2
What information does this analysis provide relating to: - (customer satisfaction) feedback? (5.6) - conformity to product requirements? (See 5.6) - characteristics and trends of processes and products? (See 5.6) - suppliers? (See 7.4.1)
8.4q3
Are the analysis of data results maintained? Can you show me an example of this type of record?
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8.5.1q1
8.5.1q2
Does the procedure for complaint handling and advisory notices address the effective and timely investigation of the problem? Are there procedures to notify appropriate regulatory authorities for incidents in compliance with the regulatory requirements (e.g. EU Vigilance System, FDA regulation)?
8.5.1q3
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