Section 1: Process Definition
1. 1. Is the process defined and documented?
Yes
No
N/A
2. 2. Is the process owner identified? (Process map, procedure or work instruction, etc.)
Yes
No
N/A
3. 3. Is there evidence that process inputs are accurately defined and understood by all employees involved?
Yes
No
N/A
4. 4. Is there evidence that process activities are accurately defined and understood by all employees involved?
Yes
No
N/A
5. 5. Is there evidence that process outputs are accurately defined and understood by all employees involved?
Yes
No
N/A
6. 6. Are inputs defined and prioritized based on risk?
Yes
No
N/A
7. 7. Have procedures, instructions, and forms been established as needed to control the process?
Yes
No
N/A
8. 8. Are procedures, instructions and forms used in controlling the process readily available?
Yes
No
N/A
9. 9. Do procedures, instructions and forms accurately reflect the practices? (Note: Requires the auditor review and observation!)
Yes
No
N/A
10. 10. Are there adequate plans in place to achieve the objectives?
Yes
No
N/A
11. 11. Is relevant customer feedback available? (Feedback from subsequent processes)
Yes
No
N/A
12. 12. Are documents understood by process participants?
Yes
No
N/A
Section 2: Process Resources
1. 1. Is there evidence of management commitment, involvement and allocation of resources?
Yes
No
N/A
2. 2. How many people participate in the process, is this adequate to achieve process requirements?
Yes
No
N/A
3. 3. Are participants adequately trained to carry out roles, responsibilities, and authorities?
Yes
No
N/A
4. 4. Is equipment (e.g. manufacturing, measuring & monitoring equipment; transport/logistics; hardware/software; PPE; etc.) adequate for its intended use?
Yes
No
N/A
5. 5. Is equipment identified to allow participants to determine its readiness for safe use prior to and during the operation?
Yes
No
N/A
6. 6. Are process owners accountable for the performance and compliance of their processes?
Yes
No
N/A
7. 7. Are employees satisfied with their work area?
Yes
No
N/A
8. 8. Is the work area clean and safe?
Yes
No
N/A
9. 9. Is there adequate equipment/tools/IT support?
Yes
No
N/A
10. 10. Are employees motivated and encouraged to make suggestions for process improvement?
Yes
No
N/A
11. 11. Are all employees aware of the organizational objectives and the current status of these measurements?
Yes
No
N/A
12. 12. Are all employees aware of who their customers are and whether they are satisfied?
Yes
No
N/A
13. 13. Are employees aware of the process metrics which their activities can affect?
Yes
No
N/A
14. 14. Are they aware of the current data analysis related to these metrics and the plans in place to achieve them?
Yes
No
N/A
Section 3: Process Execution
1. 1. Is the observed process activity consistent with approved plans and procedures?
Yes
No
N/A
2. 2. Is the process flow constructed to avoid unnecessary movement of materials and personnel?
Yes
No
N/A
3. 3. Are redundant and non-value adding activities minimized?
Yes
No
N/A
4. 4. Is material usage maximized to avoid waste?
Yes
No
N/A
5. 5. Is waste material effectively removed and segregated from the process?
Yes
No
N/A
6. 6. Are unused materials returned to the correct location in conditions suitable to allow re-use?
Yes
No
N/A
7. 7. Are process outputs passed on to subsequent processes only when all planned process activities are completed?
Yes
No
N/A
8. 8. Is there evidence of continuity between the various support processes?
Yes
No
N/A
9. 9. Do the interfaces between the departments operate smoothly?
Yes
No
N/A
10. 10. Does product information flow freely between the support processes?
Yes
No
N/A
11. 11. Is there evidence for the reduction in measurement system and process variation?
Yes
No
N/A
Section 4: Process Monitoring
1. 1. Is the process monitored, measured, analyzed and improved?
Yes
No
N/A
2. 2. Are monitoring activities carried out according to approved plans and procedures?
Yes
No
N/A
3. 3. Is process monitoring compared against standards to determine the current status of the process?
Yes
No
N/A
4. 4. Is process status communicated to appropriate members of the process team?
Yes
No
N/A
5. 5. Are records of process monitoring maintained according to approved procedures?
Yes
No
N/A
6. 6. Have key performance indicators (KPI) been established to allow the effectiveness of the process to be evaluated?
Yes
No
N/A
7. 7. Are KPI consistent with quality and business objectives?
Yes
No
N/A
8. 8. Are KPI consistent with customer requirements?
Yes
No
N/A
9. 9. Are KPI reviewed and communicated to the process team, as appropriate, by process leaders?
Yes
No
N/A
10. 10. Is the process measured for effectiveness and efficiency?
Yes
No
N/A
11. 11. When a process is not performing, is there evidence of data analysis to determine the root cause?
Yes
No
N/A
12. 12. When a process is not performing, is there evidence that the cause(s) are dealt with in accordance with procedure?
Yes
No
N/A
13. 13. Are records of process monitoring reviewed regularly to determine opportunities for corrective and preventive action?
Yes
No
N/A
Section 5: Process Improvement
1. 1. Is the performance of the process reviewed at an appropriate frequency by top management?
Yes
No
N/A
2. 2. Are process improvement objectives aligned with organizational objectives, e.g. the business plan?
Yes
No
N/A
3. 3. Is there evidence of an effective PDCA cycle?
Yes
No
N/A
4. 4. Can the process owner demonstrate how PDCA applies to their process?
Yes
No
N/A
5. 5. Can the process owner to show examples of improvements driven by their PDCA cycle?
Yes
No
N/A
6. 6. Can employees demonstrate areas of previous continual improvement?
Yes
No
N/A
7. 7. Are records of process upsets and actions taken reviewed to determine the need for corrective/preventive action?
Yes
No
N/A
8. 8. Where corrective/preventive actions have been implemented, have the action(s) taken been demonstrated as effective?
Yes
No
N/A
9. 9. Where opportunities for improvement have been implemented, have the action(s) taken been demonstrated as effective?
Yes
No
N/A
10. 10. Are all process participants encouraged to be involved in identifying improvements?
Yes
No
N/A