CBA/CQA Comparison Chart - Ombu Enterprises LLC

CBA/CQA Comparison Chart 

CBA 

CQA 

CBA Text 

Citation CQA Text 

I. Auditing Fundamentals 

B. Purpose of audits 

Describe and examine how audits are used to assess 

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organizational effectiveness, system efficiency, process 

A. Purpose & types of audits 

effectiveness, business performance, risk management, 

Differentiate various audit types (such as product, process, 

and conformance to requirements. (Analyze) I.B 

system, management, compliance, first-party, second- 


party, third-party, internal, external, desk, department, and 

C. Types of quality audits 

function) and examine how audits are used to assess 

Define and differentiate various audit types, such as 

organizational effectiveness, system efficiency, process 

product, process, system, management, compliance, 1st- 

effectiveness, business performance, risk management, 

party, 2nd-party, 3rd-party, internal, external, desk, 

and conformance to requirements. (Analyze) 


I.A department, and function. (Analyze) I.C 

B. Roles and responsibilities during an audit 


1. Participants and their roles and responsibilities 

E. Roles and responsibilities of audit participants 

Explain the functions and responsibilities of various audit 

Define and describe the functions and responsibilities of 

participants, including audit team members, lead auditor, 

various audit participants, including audit team members, 

client, auditee, etc. (Apply) I.B.1 lead auditor, client, auditee, etc. (Apply) I.E 

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B. Roles and responsibilities during an audit 

2. Ethical, legal, and professional issues 

Identify and apply factors of ethical and professional 

conduct, concepts of due diligence/due care with respect 

to confidentiality, conflict of interest, credibility, 

independence, objectivity, and qualifications. Identify 

legal and financial ramifications of improper auditor 

actions, such as carelessness, negligence, and discovery of 

illegal activities or unsafe conditions. Anticipate the effect 

that certain audit results can have on an auditee's 

regulatory and civil liability. (Apply) I.B.2 

ABOVE 

ABOVE 




F. Ethical, legal, and professional Issues 

1. Audit Credibility 

Identify and apply ethical factors that influence audit 

credibility, such as auditor independence, objectivity, and 



CBA CQA Comparison Chart Page 2 of 20 


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qualifications. (Apply) I.F.1 



2. Liability Issues 

Identify potential legal and financial ramifications of 

improper auditor actions, such as carelessness and 

negligence, in various situations, and anticipate the effect 

that certain audit results can have on an auditee's 

liability. (Apply) I.F.2 



3. Professional Conduct and Responsibilities 

Define and apply the concepts of due diligence and due 

care, with respect to confidentiality, conflict of interest, 

the discovery of illegal activities or unsafe conditions. 

(Apply) I.F.3





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II. Auditing & Inspection Processes 

II. Audit Process 

A. Audit preparation & planning 

A. Audit preparation and planning 

1. Elements of the audit planning process 

1. Elements of the audit planning process 

Determine and implement steps in audit preparation and 

Identify and implement steps in audit preparation and 

planning, such as verifying audit authority, establishing 

planning, such as verifying audit authority, determining 

the purpose, scope, and type of audit, the requirements to 

the purpose, scope, type, requirements to audit against, 

audit against, and the resources necessary, including the 

and identifying the resources necessary, including the 

size and number of audit teams. (Evaluate) 



2. Auditor selection 

Identify and examine various auditor selection criteria, 

II.A.1 size and number of audit teams. (Evaluate) II.A.1 

such as education, experience, industry background, and 


subject-matter expertise, and the characteristics that make 


auditors effective, such as interpersonal skills, problem- 

2. Auditor selection 

solving skills, attention to detail, cultural sensitivity, 

Identify and examine various auditor selection criteria, 

ability to work independently and in a group or on a team. 

such as education, experience, industry background, and 

(Analyze) II.A.2 subject matter expertise. (Analyze) 

III. Auditor Competencies 

A. Auditor characteristics 

Identify characteristics that make auditors effective, such 

as interpersonal skills, problem-solving skills, close 

attention to detail, cultural sensitivity, ability to work 

II.A.2 

ABOVE 

independently and in a group or on a team. (Apply) III.A 





3. Audit-related documentation 

3. Audit-related documentation 

Identify sources of pre-audit information and examine 

Identify the sources of pre-audit information and 

audit-related documentation, such as reference materials 

examine audit-related documentation, such as reference 

and prior audits. (Analyze) II.A.3 materials and prior audits. (Analyze) II.A.3 










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5. Auditing tools 


Select, prepare, and use checklists, log sheets, sampling 

4. Auditing tools 

plans, and procedural guidelines in various audit 

Select, prepare, and use checklists, log sheets, sampling 

situations. (Create) 

plans, and procedural guidelines in various audit 

[NOTE: Checklists as working papers are covered in II. 

situations. (Analyze) II.A.4 B. 3] II.A.5 





5. Auditing strategies 

6. Auditing strategies 

Identify and use various tactical methods for conducting 

Identify and use various tactical methods for conducting 

an audit, such as forward and backward tracing and 

an audit, such as forward and backward tracing and 

discovery. (Apply) II.A.5 discovery. (Apply) II.A.6 





6. Logistics 

4. Logistics 

Identify and organize various audit-related logistics, such 

Identify and organize various audit-related logistics, such 

as travel, security considerations, and escorts. (Apply) 


II.A.6 as travel, security considerations, and escorts. (Analyze) II.A.4 

B. Audit performance 


1. Opening meeting 


Describe the purpose and scope of an opening meeting, 

1. Opening meeting 

and the necessary elements for conducting such a meeting. 

Describe its purpose, scope, and elements and conduct an 

(Apply) II.B.1 opening meeting. (Apply) II.B.1 








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2. Data collection and analysis 

2. Data collection and analysis 

Select and apply various data collection methods, such as 

Select and apply various data collection methods, such as 

observing work activities, taking physical measurements, 

interviewing people, observing work activities, taking 

examining paper and electronic documents, etc., and 

physical measurements, and examining paper and 

analyze the results. (Evaluate) 


II.B.2 electronic documents; perform analysis. (Create) II.B.2 


III. Auditor Competencies 

3. Communication techniques 

E. Interviewing techniques 

Define and apply appropriate interviewing techniques 

Define and apply appropriate interviewing techniques 

(e.g., when to use various question types, the significance 

(e.g., when to use open-ended and closed question types, 

of pauses and their length, when and how to prompt a 

determining the significance of pauses and their length, 

response), in various situations, such as when supervisors 

and when and how to prompt a response), based on 

are present, when conducting multiple interviews, and 

various factors, such as when supervisors are present, 

when using a translator. Identify typical conflict situations 

when interviewing a group of workers, and when using a 

and appropriate techniques for resolving them. (Apply) II.B.3 translator. (Apply) 


III.E 




3. Working papers 

4. Working papers 

Identify types of working papers, such as checklists, 

Identify types of working papers, such as completed 

auditor notes, and attendance rosters, and determine their 

checklists, auditor notes, and attendance rosters, and 

importance in providing evidence for an audit trail. 

determine their importance in providing evidence for an 

(Evaluate) [NOTE: Checklists as auditing tools are 

audit trail. (Create) II.B.4 covered in II. A. 5.] II.B.3 









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4. Objective evidence 

5. Objective evidence 

Identify and differentiate various characteristics of 

Identify and differentiate various characteristics of 

objective evidence, such as observed, measured, verified, 

objective evidence, such as observed, measured, verified, 

and documented. (Analyze) 

and documented. (Evaluate) 



II.B.5 [NOTE: The definition of evidence is covered in I. A.] II.B.4 

6. Observations 


Evaluate the significance of observations in terms of 


positive, negative, chronic, isolated, and systemic. 

5. Observations 

(Evaluate) 

Evaluate the significance of observations in terms of 

[NOTE: This topic area includes general audit observation 

positive, negative, chronic, isolated, and systemic. 

classification only; FDA classification criteria are covered 

(Evaluate) 

in Body of Knowledge area II.E.3.] II.B.6 [NOTE: The definition of observation is covered in I. A.] 



II.B.5 


6. Nonconformances 


Classify nonconformances in terms of significance, 

7. Classifying nonconformances 

severity, frequency, and level of risk. (Evaluate) 

Classify nonconformances in terms of significance, 

[NOTE: The definition of nonconformance is covered in 

severity, frequency, and level of risk. (Analyze) II.B.7 I.A.] II.B.6 





8. Audit process management 

7. Audit process management 

Define and apply elements of managing an audit, 

Define and apply elements of managing an audit, 

including coordinating team activities, reallocating 

including coordinating team activities, re-allocating 

resources, adjusting the audit plan, and communicating 

resources, adjusting audit plan, and communicating with 

with the auditee during the audit. (Apply) II.B.8 the auditee. (Analyze) II.B.7 








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9. Exit meeting 

8. Exit meeting 

Describe the purpose and scope of an exit meeting and the 

Describe its purpose, scope, and elements, and conduct 

necessary elements for conducting such a meeting, 

an exit meeting, including determining post-audit 

including determining post-audit activities and who is 

activities and who is responsible for performing them. 

responsible for performing them. (Apply) II.B.9 (Apply) II.B.8 



C. Audit reporting 


1. Basic elements 

1. Basic steps 

Define, plan, and apply the steps in generating an audit 

Define, plan, and implement the steps in generating an 

report, including reviewing and finalizing results, 

audit report, including reviewing and finalizing results, 

organizing details, obtaining necessary approvals, and 

organizing and summarizing details, obtaining necessary 

distributing the report. (Create) 


II.C.1 approvals, and distributing the report. (Create) II.C.1 



2. Effective audit reports 


Report observations and nonconformances accurately, cite 

2. Effective audit reports 

objective evidence, procedures, and requirements, and 

Identify what makes an audit report effective, and 

develop and evaluate various components, such as 

develop and evaluate various components, such as 

executive summaries, prioritized data, graphic 

executive summaries, prioritized data, graphic 

presentation, and the impact of conclusions. (Create) II.C.2 presentation, and the impact of conclusions. (Create) II.C.2 





3. Record retention 

3. Records retention 

Identify and apply record retention requirements, 

Identify and apply record retention requirements, such as 

including the type of documents and storage 

type of documents, length of time, and storage 

considerations, for various audits. (Apply) II.C.3 considerations, for various audits. (Apply) II.C.3 









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D. Audit follow-up and closure 


1. Elements of the corrective and preventive action 

1. Elements of corrective and preventive action 

processes 

Identify and apply the elements of these processes, 

Identify and apply the elements of these processes, 

including problem identification, assignment of 

including problem identification, assignment of 

responsibility, root cause analysis, and recurrence 

responsibility, root cause analysis, and recurrence 

prevention. (Analyze) II.D.1 prevention. (Apply) II.D.1 





2. Review of corrective action plan 

2. Review of corrective action plan 

Use various criteria to evaluate the acceptability of 

Use various criteria to evaluate the acceptability of 

corrective action plans, and identify and apply strategies 

corrective action plans, and identify and apply strategies 

for negotiating changes to unacceptable plans. (Evaluate) 



3. Conducting audit follow-up 

Use various methods to verify and evaluate the adequacy 

II.D.2 for negotiating changes to unacceptable plans. (Evaluate) II.D.2 

of corrective actions taken, such as re-examining 


procedures, observing revised processes, and conducting 


follow-up audits or re-audits. Develop strategies when 

3. Verification of corrective action 

corrective actions are not implemented or are not 

Use various methods to verify and evaluate the adequacy 

effective, such as communicating to the next level of 

of corrective actions taken, such as re-examining 

management, re-issuing the corrective action request, etc. 

procedures, observing revised processes, and conducting 

(Evaluate) II.D.3 follow-up audits. (Evaluate) II.D.3 










4. Follow up on ineffective corrective action 

Identify and develop strategies to use when corrective 

actions are not implemented or are not effective, such as 

communicating to the next level of management, re- 

Citation 

ABOVE 

issuing the corrective action, and re-auditing. (Create) II.D.4 





4. Audit closure 

5. Audit closure 

Identify and apply various elements of, and criteria for, 

Identify and apply various elements of, and criteria for, 

audit closure. (Evaluate) 


E. Audit procedural references 

1. Guidelines for auditing quality systems 

Describe general auditing principles and approaches as 

II.D.4 audit closure. (Evaluate) II.D.5 

described in the ISO 19011 standard. (Understand) 



2. Quality System Inspection Technique (QSIT) 

Explain the purpose of QSIT and its related terms, and 

compare QSIT to other audit approaches. Differentiate the 

principal subsystems of QSIT, and use and interpret QSIT 

II.E.1 N/A -- 

sampling tables. (Analyze) II.E.2 N/A -- 









3. US compliance programs for medical devices (FDA 

CPG 7382.845) 

Explain the purpose and scope of various FDA 

inspections, including the criteria for the FDA taking 

action as a result of quality system audits, and categorize 

observations according to FDA classification criteria. 

(Apply) 

[NOTE: This topic area includes FDA classification 

criteria only; general audit observation classification is 

covered in Body of Knowledge area II.B.6.] II.E.3 N/A -- 



4. International auditing guidelines for medical devices 

(GHTF SG4 (99)28, GHTF SG4 (99)14, GHTF SG4 

(00)3) 

Apply general auditing principles for medical device 

audits. Assess the adequacy of auditors' training, their 

qualifications to conduct audits of a medical device 

manufacturer's quality system, and ongoing training to 

maintain their qualifications. Assess an audit team's ability 

to read, speak, write, and understand the native language 

used by auditee personnel and the auditee's quality system 

documentation; assess the team's ability to arrange for an 

interpreter in advance of the audit. (Apply) II.E.4 N/A -- 





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III Biomedical Quality Management System 

Requirements 

A. Regulatory requirements & guidance 

1. European directive: Medical Device Directive 

93/42/EEC of 14 June 1993 (Article 1) 

Interpret the applications of the directive. (Understand) III.A.1 N/A -- 


Requirements 


2. US requirements (FD&C Act, sections 301-304, 501- 

502, 704, 518, 513) 

Identify how the FD&C Act defines and is applied to 

medical devices and differentiate between device 

classifications and pre-market requirements. Define 

misbranding and adulteration and the implications of each. 

Describe the FDA's authority to perform establishment 

inspections and mandate product recalls. (Apply) III.A.2 N/A -- 


Requirements 


3. Labeling: 21 CFR 801, subpart A 

Apply general labeling provisions for medical devices. 

(Apply) III.A.3 N/A -- 


Requirements 


4. Establishment registration and device listing: 21 

CFR 807 

Define these requirements. (Understand) III.A.4 N/A -- 





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Requirements 


5. Electronic records and electronic signatures: 21 

CFR 11 

Define these requirements. (Understand) III.A.5 N/A -- 


Requirements 


6. FDA guideline for the manufacture of in vitro 

diagnostic (IVD) products (Jan 10, 1994) 

Define IVD devices and other terms related to the use of 

good manufacturing practices (GMPs) for IVDs. 

(Understand) III.A.6 N/A -- 


Requirements 

B. Quality systems regulations & standards 

1. 21 CFR 820 

Identify FDA explanations and justifications for the 

content of the QSReg from the preamble; apply the scope 

and defined terms to medical devices. (Understand) III.B.1 N/A -- 


Requirements 


2. ISO 9001, ISO 9002, ISO 13485, ISO 13488 

Evaluate the selection, interpretation, and implementation 

of these various quality system standards. (Evaluate) III.B.2 N/A -- 





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Requirements 


3. GHTF.SG3.N99-8 

Evaluate the selection and use of this guidance for an 

auditee's quality system. (Evaluate) III.B.3 N/A -- 


Requirements 

C. Management controls 

Examine management responsibility for the quality 

system, including organization, resources, management 

review, quality audits, and personnel requirements. 

(Analyze) III.C N/A -- 


Requirements 

D. Design controls 

Evaluate the scope and purpose of design control elements 

and implementation of a design control system. Assess the 

design control system for compliance to the Medical 

Device Directive (MDD), including Essential 

Requirements, harmonized standards, risk analysis, and 

clinical investigation. (Evaluate) III.D N/A -- 


Requirements 

E. Corrective and preventive actions (CAPA) 

1. Existing and potential problem resolution 

Distinguish correction, corrective action, and preventive 

action, and explain their importance in terms of 

management responsibility, methods of implementing 

these tools, etc. Describe how trending is used as it relates 

to corrective and preventive action data. (Evaluate) III.E.1 N/A -- 





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Requirements 


2. Identification and control of nonconforming product 

(820.90) 

Define and apply various methods for detecting and 

controlling nonconforming product. (Analyze) III.E.2 N/A -- 


Requirements 


3. Post-market surveillance 

Review and analyze complaint handling and servicing 

processes. Distinguish between vigilance and medical 

device reporting (MDR) requirements and processes. 

Evaluate the requirements and processes for product 

recall, corrections, removals, and medical device tracking. 

(Evaluate) III.E.3 N/A -- 


Requirements 

F. Production and process controls (P&PC) 

1. Document and change control (820.40, 820.180- 

820.186) 

Identify and distinguish between device master records 

(DMRs), design history files (DHFs), device history 

records (DHRs), and quality system records. Explain 

document and change control. (Analyze) III.F.1 N/A -- 





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Requirements 


2. Purchasing controls and acceptance activities 

(820.50, 820.80, [including product identification & 

traceability] 820.60, 820.65) 

Explain the importance of having adequate controls in 

purchasing products, components, and services, and the 

use of appropriate identification and acceptance activities. 

(Understand) III.F.2 N/A -- 


Requirements 


3. Handling, storage, distribution and installation 

(820.140-820.170) 

Identify the requirements for these processes. 

(Understand) III.F.3 N/A -- 


Requirements 


4. Validation and process controls (820.70, 820.75, 

820.72, GHTF.SG3.N99-10) 

Assess a validation process and production and process 

controls in relation to components, materials, technology, 

product use, industry standards, production standards, test 

methods, and calibration. (Evaluate) III.F.4 N/A -- 


Requirements 


5. Packaging and labeling controls (820.120, 820.130) 

Identify these requirements. (Understand) III.F.5 N/A -- 





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Requirements 


6. Sampling techniques (820.250(b)) 

Identify, interpret, and use various sampling methods, 

such as acceptance, random, and stratified, and define 

related concepts (e.g., consumer and producer risk, and 

confidence level), as used in the biomedical field. (Apply) III.F.6 N/A -- 


Requirements 


7. Statistical techniques (820.250(a)) 

Identify, interpret, and use various measures of central 

tendency (mean, median, and mode), and dispersion, such 

as standard deviation and frequency distribution. Identify 

appropriate rationales for statistical techniques used in the 

biomedical field. (Apply) III.F.7 N/A -- 

IV. Technical Biomedical Knowledge 

A. Risk management 

Identify the steps necessary for risk analysis of medical 

devices. Identify known or foreseeable hazards for 

medical devices in both normal and fault conditions, and 

describe suitable methods for risk estimation. Evaluate 

risk analysis reports for completeness, and use FMEA, 

FTA, and other tools to assess risk in a variety of 

situations. (Evaluate) IV.A N/A -- 


B. Sterilization 

1. Definitions 

Distinguish between aseptically processed products and 

terminally sterilized products. (Understand) IV.B.1 N/A -- 





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2. Standards 

Identify the standards applicable to each sterilization 

process, including ISO 11134, ISO 11135, ISO 11137, 

ISO 11737, ISO 11138, ISO/TIR 13409, EN 550/552/554, 

and EN 556. (Understand) IV.B.2 N/A -- 



3. Methods 

Identify elements of sterilization validation, including 

commissioning of equipment installation and process 

qualification (physical and microbiological) and determine 

appropriateness. Identify appropriate process controls and 

monitors for each sterilization process and determine 

whether they are incorporated and documented properly. 

(Understand) IV.B.3 N/A -- 



4. Packaging of sterile products 

Interpret the appropriate standard for sterile product 

packaging, including ISO 11607 and EN 868-1. 

(Understand) IV.B.4 N/A -- 


C. Biocompatibility 

Define various biocompatibility terms, associated tests, 

and test selection rationale in accordance with ISO 10993, 

FDA Blue Book #G95-1, and U.S. Pharmacopoeia (USP) 

Classes V & VI. (Understand) IV.C N/A -- 





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D. Controlled environments and utility systems 

1. Controlled environments 

Apply appropriate controlled environment classes for 

various medical devices. Identify and interpret controlled 

environment specifications as required by ISO 14644 and 

Federal Standard 209 E. Interpret qualifications, 

validation, and monitoring, including cleaning, 

disinfection, and sanitization in terms of controlled 

environment specifications, classifications, and standards. 

Verify that appropriate training and personnel practices 

are in use for controlled environments. (Evaluate) IV.D.1 N/A -- 


D. Controlled environments and utility systems 

2. Utility systems 

Recognize water, compressed gas, and HVAC utilities 

used in medical device manufacturing and determine 

whether they require qualification, validation, or 

maintenance according to U.S. Pharmacopoeia (USP), 

ISO 14644, Federal Standard 209E, or ISO 11134 

standards. (Understand) IV.D.2 N/A -- 





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E. Software development for products, processes, and 

quality systems 

Define the major elements of software development, such 

as requirements specifications, unit testing, integration and 

systems testing, verification, validation, etc., in 

accordance with FDA software Guidance for FDA 

Reviewers and Industry, (May 29, 1998), General 

Principles of Software Validation, 21 CFR Part 11, and 

ISPE Good Automated Manufacturing Practice (GAMP4) 

requirements. (Understand) IV.E N/A -- 


F. Laboratory testing 

Review validation procedures used for laboratory test 

methods and determine whether they are appropriate. 

(Evaluate) IV.F N/A -- 

V. Quality Tools & Techniques 

A. Fundamental quality control tools 

Interpret and apply Pareto charts, cause and effect 

diagrams, flowcharts, control charts, check sheets, scatter 

diagrams, and histograms. (Apply) V.A 


B. Quality improvement tools 

Interpret and apply problem-solving tools, such as root 

cause analysis, the six sigma model (DMAIC), lean tools, 

Plan-Do-Check-Act (PDCA), and corrective and 

preventive action (CAPA) methods. (Apply) V.B 


C. Process capability 

Identify and interpret various process capability indices, 

such as Cp and Cpk. (Understand) V.C 

V. Quality Tools And Techniques 

A. Fundamental quality control tools 

Identify, interpret, and apply Pareto charts, cause and 

effect diagrams, flowcharts, control charts, check sheets, 





Citation 

scatter diagrams, and histograms. (Analyze) V.A 


B. Quality improvement tools 

Identify, interpret, and apply problem-solving tools, such 

as root cause analysis, the six sigma model (DMAIC), 

lean tools, Plan-Do-Check-Act (PDCA), and corrective 

and preventive action (CAPA) methods. (Apply) V.B 


E. Process capability 

Identify and interpret various process capability indices, 

such as Cp and Cpk. (Understand) V.E





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D. Qualitative and quantitative analysis 

F. Qualitative and quantitative analysis 

Describe and distinguish between qualitative and 

Describe and distinguish between qualitative and 

quantitative analyses, and attributes and variables data. 

quantitative analyses, and attributes and variables data. 

(Analyze) V.D (Analyze) 


V.F 


G. Cost of quality 

E. Cost of quality 

Identify the basic cost of quality (COQ) principles, and 

Identify the basic cost of quality (COQ) principles, and 

describe the four COQ categories: prevention, appraisal, 

describe the four COQ categories. (Understand) V.E internal failure, and external failure. (Understand) V.G

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