ASQ CFSQA Certification Exam Syllabus

I. Food Safety and HACCP System (27 Questions)

• a. Good Manufacturing Practices (GMPs), including personal hygiene programs
• b. Good Agricultural Practices (GAPs)
• c. Good Laboratory Practices (GLPs), including testing continuity plan
• d. Sanitation Standard Operating Procedures (SSOPs)
• e. Chemical and hazardous materials control
• f. Employee training
• g. Calibration of equipment
• h. Integrated Pest Management (IPM)
• i. Foreign material control (e.g., wood, metal, glass, brittle plastic, and ceramic control)
• j. Maintenance programs (e.g., preventive, routine, emergency, and temporary)
• k. Waste management
• l. Supplier and material qualification (e.g., raw materials, finished goods, and primary packaging)
• m. Distribution and transportation

2. Product traceability and recall
- Define and distinguish between material identification and status in relation to product traceability and recall such as label control, mock recalls, and traceability exercises. (Analyze)

3. Crisis management
- Understand and apply crisis management plans including business continuity and outbreak management. (Apply)

4. Food defense and facility design
- Apply facility design, security methods and operational conditions necessary to mitigate bioterrorism threats and intentional adulteration. (Apply)

5. Environmental control and monitoring
- Apply various programs to support proper environmental conditions such as 1) controls for temperature, 2) humidity, 3) dust, 4) pathogens, 5) water, 6) air and ice safety, and 7) facility design elements. (Analyze)

6. Food fraud
- Understand the impact caused by the intentional or unintentional use of ingredients (e.g., substitution, mislabeling, misbranding, dilution, and counterfeiting) that may compromise economic integrity, safety of the final product, or quality of the final product. (Understand)

1. Process controls
- Analyze appropriate procedures, practices, and processes for safe manufacturing, processing, packing, or holding of food to significantly minimize or prevent hazards, including but not limited to sanitation, process, CCP practices, and prerequisite programs. (Analyze)

2. Supply chain control
- Apply supplier preventive process control measures and methods (e.g. sanitary transport, appropriate in-house storage, and appropriate labeling) used for hazard analysis and control, supplier performance and for documenting process control. (Apply)

3. Allergen control
- Analyze specifications used for control within an allergen management process (e.g., storage, labeling, packaging, and shipping). Explain how specifications are used for preventing or mitigating cross-contact and cross-contamination. (Analyze)

II. Food Safety and HACCP Management (9 Questions)

1. Assemble and train the Food Safety and HACCP team, including qualified individuals.
2. Describe the product and its distribution.
3. Describe the intended use of the product and its end-user (e.g., consumer, patient, vulnerable group).
4. Develop a product or process flow diagram.
5. Verify the product or process flow diagram.

III. HACCP Principles (22 Questions)

1. Identify the cause of the deviation.
2. Determine disposition of affected product.
3. Identify and document corrective action.
4. Implement corrective action and determine its effectiveness.
5. Reevaluate the HACCP plan after changes have been made.

1. Verify prerequisites and CCPs.
2. Review documents and records.
3. Review calibration processes and system operation.
4. Test and analyze product samples.
5. Validate the HACCP system.

1. Documents and records used to develop the initial HACCP plan
2. CCP monitoring records
3. Records of corrective actions taken in response to deviations, including root cause analysis results, verification activities, etc.
4. A formal document control system

IV. Implementation and Maintenance of Food Safety and HACCP System (21 Questions)

1. Conduct a pilot or initiate the system.
2. Conduct operational qualifications (critical control points, process control plans, etc.).
3. Assess training programs.
4. Evaluate the project’s effectiveness in relation to its stated objectives.
5. Review the system requirements (regulatory, internal, etc.) to determine whether changes need to be made.

1. Validate the stated system objectives in relation to the results of the pilot, system initiation, or product/process change as needed.
2. Reassess the system periodically to verify that the requirements are met through reviewing data sources such as complaints, recalls, deviations, and corrective actions.

V. Auditing Fundamentals (23 Questions)

1. Audit credibility
- Identify and apply ethical factors that influence audit credibility such as auditor independence, objectivity, and qualifications. (Apply)

2. Liability issues
- Identify potential legal and financial ramifications of improper auditor actions (e.g., carelessness and negligence) and the effects such actions can have on liability issues for all parties. (Apply)

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, etc. (Apply)

VI. Auditing Process and Auditor Competencies (23 Questions)

1. Elements of audit planning
- Identify and implement audit planning steps, including verifying audit authority, determining the purpose, scope, type of audit, requirements to audit against, and resources necessary, such as size and number of audit teams. (Evaluate)

2. Pre-audit documents
- Identify and analyze pre-audit documents such as audit criteria or reference materials, prior audit results, etc. (Evaluate)

3. Auditing strategies
- Identify and use various tactical methods for conducting an audit, including forward- and backward-tracing, discovery, etc. (Apply)

1. Opening meeting
- Describe the elements of an opening meeting, including explaining to the auditee the purpose, scope, and elements of the audit to be conducted. (Apply)

2. Data collection and analysis
- Select and apply various data collection methods, such as obtaining access to documents, interviewing people, observing work activities, taking physical measurements, examining paper and electronic documents, and confirming flow diagrams, and analyze the results. (Evaluate)

3. Working papers
- Identify types of working papers, such as checklists, auditor notes, attendance rosters, etc., and determine their importance in providing evidence for an audit trail. (Evaluate)

4. Objective evidence
- Identify and differentiate various characteristics of objective evidence, such as observed, measured, verified, and documented. (Analyze)

5. Observations
- Evaluate the significance of observations in terms of positive, negative, chronic, isolated, and systemic. (Evaluate)

6. Nonconformances
- Classify nonconformances in terms of significance, severity, frequency, and level of risk. (Evaluate)

7. Audit process management
- Define and apply elements of managing an audit as it is being performed, including coordinating team and team member activities, reallocating resources, adjusting audit plans when necessary, and communicating with the auditee as needed. (Analyze)

8. Exit meeting
- Describe the elements of an exit meeting, including presenting audit observations and findings to the auditee and discussing post-audit activities, who will be responsible for performing them, and their deadlines. (Apply)

1. Basic steps
- Implement the common steps in generating an audit report, including reviewing and finalizing results, organizing and summarizing details, obtaining necessary approvals for report distribution, etc. (Evaluate)

2. Effective audit reports
- Evaluate various components that make audit reports effective: e.g., executive summary, prioritized data, graphical data presentation, and the impact of conclusions. (Evaluate)

1. Corrective and preventive action (CAPA)
- Identify and apply CAPA elements, including problem identification, assigning responsibility, root cause analysis, recurrence prevention, etc. (Apply)

2. Review and verification of corrective action plans

- Use various methods to verify and evaluate corrective actions plans, including examining revised procedures and processes or re-auditing to confirm the adequacy of corrective actions taken. (Apply)

3. Follow-up on ineffective corrective actions
- Identify and develop strategies to use when corrective actions are not implemented or are not effective, including communicating to the next level of management, re-issuing the corrective action, re-auditing, etc. (Evaluate)

4. Audit closure
- Identify various elements of audit closure and any criteria that have not been met and would prevent an audit from being closed. (Evaluate)

5. Records retention
- Identify and apply record retention requirements, such as type of documents to be retained, length of time to keep them, and storage considerations. (Apply)

1. Characteristics
- Identify characteristics that make auditors effective, such as interpersonal skills, problem-solving skills, close attention to detail, the ability to work independently and in a group or on a team. (Apply)

2. Conflict resolution
- Identify typical conflict situations (disagreements, auditee delaying tactics, interruptions, etc.) and determine appropriate techniques (negotiation, cool-down periods, etc.) for resolving them. (Apply)

3. Written communication techniques
- Develop and review technical reports for critical factors, including whether the document meets the needs of the intended audience, how the report will be used, what type of photographs, illustrations, or graphics will be effective, etc. (Apply)

4. Interviewing techniques
- Define and use appropriate interviewing techniques, including active listening, open-ended or closed question types, determining the significance of pauses and their length, prompting a response, clarifying by paraphrasing, etc., in various situations, such as when supervisors are present, during group interviews, a group of workers, when using a translator, etc. (Apply)

5. Team dynamics and facilitation skills
- Define and use various techniques to support team-building efforts and to help maintain group focus, both as a participant and as a team leader. Describe the classic stages of team development (forming, storming, norming, performing and adjourning, and use coaching, guidance, and other facilitation techniques to support effective teams. (Apply)

VII. Quality Tools and Techniques (10 Questions)