NC-CAPA

Question Title

1. Date (Required.)

Date / Time

Date

Question Title

2. Name of Reporter (Required.)

Question Title

3. Short description of the problem, error or audit finding *

Question Title

4. Affected Area

CERT

OPS

EXAMDEV

QMS

PROFDEV

Question Title

5. Source of Finding? *

Complaint

Communication Issue

Customer Contact

Notification from Vendor

Internal Audit

External Audit

Vendor Error

Self-identified

Website

Question Title

6. Attach supporting documents, e.g. emails, audit findings or documents describing the problem

Question Title

7. Attach supporting documents, e.g. emails, audit findings or documents describing the problem

Question Title

8. What type of error, problem, audit finding, or nonconformity occurred? *

Does not meet intended use

Does not meet requirements

Did not follow the process or procedure

Current version of procedure not used or available

Customer error or customer not properly informed

Incomplete record

Incorrect information used/provided

Product does not meet specifications

Training

Product, Process or Service Quality

Vendor error

Inadvertent error

Test Publication Errors

Other anomaly

Question Title

9. Potential Root Cause (what caused the error, problem or audit finding) *

EXT: external error, vendor, customer

PRO: Documented process or procedure not accurate or clear

INC: Incorrect information used or received

CUST: Customer complaint

ERR: Inadvertent human error

SPEC: Does not meet specifications or requirements

UNSPEC: Cause of error/problem not determined

Question Title

10. Type of action taken to correct the error, problem or audit finding *

Immediate correction (what was done to immediately correct the error/problem/audit finding)

Corrective action (long term action to prevent error/problem/audit finding from recurring)

Preventive Action (action(s) taken to prevent the occurrence of potential error/problem/audit finding)

Improvement (action(s) taken to improve the process or procedure)

NC-CAPA

Question Title

1. Date (Required.)

Question Title

2. Name of Reporter (Required.)

Question Title

3. Short description of the problem, error or audit finding *

Question Title

4. Affected Area

Question Title

5. Source of Finding? *

Question Title

6. Attach supporting documents, e.g. emails, audit findings or documents describing the problem

Question Title

7. Attach supporting documents, e.g. emails, audit findings or documents describing the problem

Question Title

8. What type of error, problem, audit finding, or nonconformity occurred? *

Question Title

9. Potential Root Cause (what caused the error, problem or audit finding) *

Question Title

10. Type of action taken to correct the error, problem or audit finding *

Question Title

11. Briefly describe what else needs to be done to correct the error, problem or audit finding, a date for completion, and the responsible person(s) *

Question Title

12. Attach supporting documentation for corrective action

Question Title

13. Attach supporting documentation for corrective action

Question Title

14. Quality Assurance Check

NC-CAPA

Question Title

* 1. Date (Required.)

Question Title

* 2. Name of Reporter (Required.)

Question Title

* 3. Short description of the problem, error or audit finding *

Question Title

* 4. Affected Area

Question Title

* 5. Source of Finding? *

Question Title

* 6. Attach supporting documents, e.g. emails, audit findings or documents describing the problem

Question Title

* 7. Attach supporting documents, e.g. emails, audit findings or documents describing the problem

Question Title

* 8. What type of error, problem, audit finding, or nonconformity occurred? *

Question Title

* 9. Potential Root Cause (what caused the error, problem or audit finding) *

Question Title

* 10. Type of action taken to correct the error, problem or audit finding *

Question Title

* 11. Briefly describe what else needs to be done to correct the error, problem or audit finding, a date for completion, and the responsible person(s) *

Question Title

* 12. Attach supporting documentation for corrective action

Question Title

* 13. Attach supporting documentation for corrective action

Question Title

* 14. Quality Assurance Check

1. Date (Required.)

2. Name of Reporter (Required.)

3. Short description of the problem, error or audit finding *

4. Affected Area

5. Source of Finding? *

6. Attach supporting documents, e.g. emails, audit findings or documents describing the problem

7. Attach supporting documents, e.g. emails, audit findings or documents describing the problem

8. What type of error, problem, audit finding, or nonconformity occurred? *

9. Potential Root Cause (what caused the error, problem or audit finding) *

10. Type of action taken to correct the error, problem or audit finding *

11. Briefly describe what else needs to be done to correct the error, problem or audit finding, a date for completion, and the responsible person(s) *

12. Attach supporting documentation for corrective action

13. Attach supporting documentation for corrective action

14. Quality Assurance Check