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Background
Each of the 8 elements was assigned a weight agreed upon by the Food and Drug Administration's (FDA’s) Third Party Recognition Board (TPRB) in conjunction with the Center for Devices and Radiological Health (CDRH) Senior Staff. Each applicant's package will be assessed by the TPRB. After assessment by the TPRB each of the 8 elements will be voted a "quality level” score from 0-4; 0 = Unsatisfactory, 2= Satisfactory, and 4= Exceeds.
Each element has been assigned a weight of 5, 15 or 20. The weight of the element is based on how essential the information in the element is, in determining if the applicant is suitable to perform Quality System/Good Manufacturing Practices (QS/GMP) inspections on behalf of FDA.
Quality Level Score x Weight = Element Score. The 8 element scores will be totaled to yield an "Application Rating" (maximum rating attainable is 400). TPRB will rank the applications (highest application rating first). MDUFMA requires that no more then 15 persons be accredited during the 12 months that follows the publication of this guidance.
Definition of Acceptance Level Score
Exceeds = (4) A rating of "Exceeds" is determined for an element when all items within an element are Satisfactory and at least 50% are substantially above the standard.
Satisfactory = (2) A rating of "Satisfactory" is determined for an element when processes for adequately accomplishing the requirements are fully explained and supporting documentation confirms the process.
Unsatisfactory = (0) A rating of "unsatisfactory" is determined for an element when the process for accomplishing the requirement is inadequate, not clearly and fully explained or supporting documentation is missing/incomplete.
Quality Level Score x Weight= Element Score
Shaded Areas to be Completed by TPRB |
ACCREDITED PERSON INSPECTION PROGRAM RATING CRITERIA
Checklist for evaluating application to determine if they meet FDA’s criteria for conducting QS/GMP FDA inspections
Document Type: Original Supplement
Applicant Number: __________ Applicant: _____________
Value ____ x Weight __15__ = Element Score ________ |
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1. |
ADMINISTRATIVE INFORMATION |
Rating U-S-E |
Where found in AP Guidance |
AP applicant should identify where process, procedures, or documentation is found in AP application |
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AP applicant has provided the following administrative information:
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See IV. B. 1. “Administrative Information” Pages 23 - 24
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AP applicant has provided the following administrative information:
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See IV. B. 1. “Administrative Information” Pages 23 - 24
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Value ____ x Weight __20__ = Element Score ________ |
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2 |
PREVENTION OF CONFLICT OF INTEREST |
U-S-E |
Where found in Guidance |
AP applicant should identify where process, procedures, or documentation is found in AP application |
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2.1
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See IV. B. 2. “Prevention of Conflict of Interest” Pages 24 - 25
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2.2
| Policy statement that, at a minimum states:
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See III. G. “What Qualifications are Necessary to Become an Accredited Person” Pages 12 - 13 |
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2.3
| Policy statement that at a minimum states:
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See III. H. 3. “How Can I Address these Qualifications in My Applica- tion to FDA” Page 15 |
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2.4 | Procedures to ensure that:
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See III. G. 5. “What Qualifications are Necessary to Become an Accredited Person?” Page 13
See IV. B. 8. “Certification Agreement Statement” Page 28 |
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Value ____ x Weight __20__ = Element Score ________ |
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3 |
Technical Competence |
U-S-E |
Where found in Guidance |
AP applicant should identify where process, procedures, or documentation is found in AP application |
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3.1 | Procedures to ensure that AP inspections are performed by competent and qualified personnel. |
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See IV. B. 3. “Technical Competence” Pages 25 - 26 |
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3.2 | Procedures to ensure personnel involved in the AP inspection process have satisfactory knowledge of the United States ( U.S.) FDA laws and regulations for medical devices, meet educational requirements, and have adequate experience in their area of competence. |
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See above |
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3.3
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Copy of educational requirements for AP inspectors? T he minimum education will generally be equivalent to a 4 year college/university degree in the U.S., including a minimum of 30 semester hours in one or a combination of the following: biological sciences, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, or related scientific fields that provide knowledge directly related to FDA consumer safety officer work. |
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See above |
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3.4 | Procedures to ensure that at least one member of an assessment team is trained and/or experienced in each of the following skills that is relevant to the assessment being made:
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See III. H. 1. “Personnel” Pages 13 – 14
See IV. B. 3 “Technical Competence” Pages 25 - 26 |
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3.5 | Procedures to ensure that the inspection team is able to recognize, collect, and identify appropriate nonconformities to support assessments and evaluations of the manufacturer's level of conformance with US FDA regulatory requirements for medical devices. |
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See III. H. 1. “Personnel” Pages 13 - 14 |
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3.6
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Procedures to ensure that AP inspectors are able to communicate verbally so as to clearly explain to the manufacturer: (1) the purpose and scope of the inspection; (2) any nonconformities identified; and (3) respond appropriately to questions asked by the manufacturer. |
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See above. |
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3.7
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Documentation that AP inspectors are able to report the findings of the inspection in written English in accordance with a report format specified by FDA. |
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See above.
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3.8 | Evidence that personnel involved in inspecting quality systems are qualified in accordance with ISO 10011-2or GHTF Study Group 4 documents. |
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See above. |
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3.9 | Evidence that management of quality systems assessments is in accordance with ISO 10011-3 or GHTF Study Group 4 documents. |
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See above. |
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3.10 | Copies of CVs for all personnel involved in the inspection process. CVs should include documentation addressing knowledge, education, training, skills, abilities and experience for all personnel involved in the AP inspectional process. |
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See above. |
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3.11 | Copy of the training plan that addresses the development of knowledge, skills, and abilities to perform AP inspections in a competent and consistent manner. |
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See IV. B. 3. “Technical Competence” Pages 25 - 26 |
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3.12 | Procedures to ensure that records are available to demonstrate that personnel have the appropriate experience and have received appropriate training relevant to the applicant's planned inspection activities. |
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See above. |
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3.13 | Records for each AP inspector include, at a minimum, the following information?
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See above. |
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3.14 | Description of the management structure and supervision of the AP inspectors including any contractors involved in the inspectional process. |
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See above. |
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Value ____ x Weight __5__ = Element Score ________ |
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4 | Resources |
U-S-E |
Where found in Guidance |
AP applicant should identify where process, procedures, or documentation is found in AP application |
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4.1 | A statement that appropriate references (e.g., FD&C Act, regulations, statutes, laws, applicable compliance programs, Regulatory Procedures Manual, Inspectional Operations Manual, Compliance Policy Guides, etc.) are available to enable inspectors to carry out inspections effectively. |
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See III. H. 2. “Infra- structure" Page 14
See IV. B. 4. “Resources” Page 26 |
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4.2 | A statement that buildings and resources (e.g., computer system with a modem, independent facsimile machine, security/safeguards for protecting any commercial, trade secrets and confidential information, etc.) that enable the applicant to perform the technical and administrative tasks connected with auditing. |
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See above. |
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Value ____ x Weight __5__ = Element Score ________ |
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5 |
Confidentiality |
U-S-E |
Where found in Guidance |
AP applicant should identify where process, procedures, or documentation is found in AP application |
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5.1 | Procedures to ensure confidentiality of all information obtained in the course of conducting AP inspections. |
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See III. G. “General Require-ments” Item 5 iii - v
See IV. B. 5. “Confidential-ity” Page 27
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5.2 | Procedures to ensure that no details, records, results, or information of any kind are disclosed to any other party except the US Food and Drug Administration, and the firm inspected. |
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See above. |
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5.3 | Procedures that the AP applicant uses to inform its personnel, including contractors of its confidentiality requirements (e.g. staff may sign a declaration not to divulge any information gained through the inspection process) |
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See above. |
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Value ____ x Weight __15__ = Element Score ________ |
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6 |
CONTRACTORS – This element is applicable unless the applicant states that no contractors will be used for FDA inspectional work. Applicants not using contractors will receive element score of 60. |
U-S-E |
Where found in Guidance |
AP applicant should identify where process, procedures, or documentation is found in AP application |
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6.1
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Procedures to ensure that contractors and their personnel conform to the same requirements (e.g. education, training, experience, and technical competence) that would apply to the AP and its personnel. |
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See III. H. 3. “Prevention of Conflict of Interest” Pages 15 - 16
See IV. B. 6. “Contrac-tors” Page 27 |
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6.2
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Procedures to ensure that the applicant will not subcontract the responsibility for supervising the inspectional process or reviewing the inspection reports. |
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See above. |
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6.3 | Procedures to ensure that when an AP applicant subcontract those parts of the inspection that require specialized knowledge, the AP applicant will possess sufficient knowledge to exert supervisory control over the contractor so that the final decision rest with the AP applicant. |
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See above. |
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6.4
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Copy of an agreement between the applicant and the contractor reflecting obligations, including confidentiality and the provision of access to records for the U.S. FDA. The agreement should include: |
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See above. |
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6.4.1 | A requirement that the contractor certify conformance with the conflict of interest requirements. |
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See above. |
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6.4.2 | A prohibition against contractors further subcontracting their duties. |
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See above. |
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6.5
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Documentation that subcontracted activities are carried out according to detailed documented procedures which are the same as, or judged by the applicant to be equivalent to, those followed by the applicant when auditing for conformance with US FDA regulatory requirements for medical devices. |
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See III. H. 3. “Prevention of Conflict of Interest” Pages 15 - 16
See IV. B. 6. “Contrac-tors” Page 27 |
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6.6
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Written policies and procedures for maintaining a current register of all contractors, and a copy of the register |
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See above. |
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Value ____ x Weight __15__ = Element Score ________ |
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7 |
QUALITY SYSTEM OF THE APPLICANT |
U-S-E |
Where found in AP Guidance |
AP applicant should identify where process, procedures, or documentation is found in AP application |
---|---|---|---|---|
7.1
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Documentation The AP applicant’s established procedures and records, which demonstrate its compliance with U.S. FDA policies and procedures relevant to AP inspections. Copies of policies and procedures the AP applicant follows to control quality system documentation. This includes procedures to assure that a current version of all AP inspection-related SOPs are available at all locations performing work for the AP. |
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See IV. B. 7. “Accredited Person Quality System” Page 28 |
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7.1.1
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AP applicant’s documentation includes at least the following: Records to support the evaluation, the assessment, and conclusions about the manufacturer's compliance with the regulatory requirements of the US FDA for medical devices. |
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See above. |
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7.2
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The AP applicant’s policies and procedures to ensure that the defined quality system procedures are implemented effectively (e.g., internal inspections) |
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See above. |
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Value ____ x Weight __5__ = Element Score ________ |
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8 |
CERTIFICATION/AGREEMENT STATEMENT |
U-S-E |
Where found in Guidance |
AP applicant should identify where process, procedures, or documentation is found in AP application |
---|---|---|---|---|
8.1
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Is there a statement, signed by the most responsible individual at the applicant, certifying/ agreeing that
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See IV. B. 8. “Certification Agreement Statement” Page 28 |
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TOTAL ELEMENT SCORE: _________
Conclusion:
Applicant: Approved Disapproved
Date of Review:
Name of Rating Board Member(s):
Updated March 21, 2006
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