Effectiveness Checks (EC)

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1.0 Purpose 
 
 The purpose of this procedure is to provide a system to evaluate and verify that actions taken to
 correct and/or prevent an identified nonconformance or quality systems problem adequately
 
 mitigate the identified problem. . 
 
 2.0 Scope 
 
 This procedure applies to the evaluation of the effectiveness of Corrective Actions and
 
 Preventative Actions (CAPA). CAPA evaluated by this procedure include CAPA Quality
 Events given a CAPA Event Number, as well as CAPA referenced as actions already
 
 completed within other quality events. 
 
 3.0 Responsibility 
 
 3.1 It is the responsibility of all employees assigned to complete an EC to:
 
 3.1.1 Sign form QS-113-F1 Effectiveness Check Assignment, accepting responsibility
 
 for the assignment. 
 
 3.1.2 Complete the assignment in a timely manner. 
 
 3.1.3. Provide progress updates as applicable. 
 
 3.1.4 Initiate form QS-113-F2 Effectiveness Check Closure when the EC is complete.
 
 3.2 ‘It is the responsibility of Quality to: 
 
 3.2.1 Determine if an EC is needed at the close of a quality event.
 
 
 

[SOP 

 Standard Operating Procedure SOPNo | Rev Diodes 
 Effectiveness Checks (EC) 
 QS-113 1 age 20 
 
 3.3 It is the responsibility of Document Control / Quality to: 
 
 3.3.1 Follow SOP QS-112 Core Quality Systems and Quality Events when assigning,
 
 logging, and managing EC Events. 
 
 3.3.2 Approve or reject EC Assignments and EC Closures. 
 
 4.0 Definitions 
 
 4.1 Quality Event — the issuance of an event number for a quality system subject to this
 procedure and as defined in the scope of specific procedures associated with that system
 
 4.2 cGMP — Current Good Manufacturing Practices 
 
 4.3 EC — Effectiveness Check 
 
 44 CAPA -— Corrective and Preventative Action 
 
 4.5 DC — Document Control 
 
 4.6 CQS — Core Quality System 
 
 5.0 References 
 
 5.1 QS-113-F1, Form, Effectiveness Check (EC) Assignment 
 
 5.2 QS-113-F2, Form, Effectiveness Check (EC) Closure 
 
 5.3 QS-112, SOP, Core Quality Systems and Quality Events 
 
 5.4 QS-112-F1, Form, Quality Event Extension Request 
 
 a3 QS-112-F2, Form, Quality Event Cancellation Request 
 
 5.6 QS-112-F3, Form, Quality Event Amendment Request 
 
 Dut QS-108, SOP, Corrective and Preventative Action (CAPA) 
 
 
 

[SOP 

 Standard Operating Procedure SOPNo | Rev 
 Effectiveness Checks (EC) QS-113 1 Page 3 of 6 
 
 5.8 C-501, SOP, Document Control 
 
 5.9 C-502, SOP, Record Storage, Retention, and Destruction 
 
 6.0 Procedure 
 
 6.1 EC Source / Reference 
 
 6.1.1 The need for an EC is determined based on direction in other quality systems.
 
 For example, a CAPA may conclude that an effectiveness check is required. If
 that is the case, then reference the event number for the CAPA as the EC Source
 
 on form QS-113-F1 Effectiveness Check (EC) Assignment. 
 
 A CAPA event number is not required if the corrective or preventative action is
 
 already complete. In that case, other quality events reference the actions taken
 without a CAPA number. In the absence of a CAPA event number, reference
 
 the event that lists the action that the EC intends to check as applicable.
 
 6.2 EC Applicability 
 
 6.2.1 Not all CAPA require an EC. Quality Management will determine if an EC is
 
 required. Reasons for assigning an EC include (1) building confidence that the
 solution will work, (2) validating that the solution did work, and (3) minimizing
 
 tisk or potential problems that might cause reoccurrence. Verifying the
 effectiveness of a CAPA closes the loop between identifying a problem and
 
 completing the actions to solve a problem. 
 
 6.2.2 If the root cause and CAPA are apparent, then an EC is not required.
 
 6.2.3 If there is uncertainty in the root cause, if there is uncertainty in the selected
 
 CAPA, or if there are changes in a procedure or test method then consider
 applying an EC. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 QS-113 1 Page 4 of 6 
 Effectiveness Checks (EC) 
 
 6.2.4 Unless a quality system procedure indicates otherwise, Quality is responsible for
 making the determination of the need for assignment of an EC at the close or
 
 assignment of that quality event as applicable. Quality personnel may always
 
 escalate the decision for applicability of an EC assignment to upper level quality
 management. 
 
 6.3 EC Plan on QS-113-F1 Effectiveness Check (EC) Assignment 
 
 6.3.1 The EC Plan of form QS-113-F1 Effectiveness Check (EC) Assignment is a
 
 description of how to evaluate whether a CAPA accomplished the intended
 purpose. The person assigned to complete the EC must review and understand
 
 the source of the EC to understand the intent of the EC. 
 
 6.3.2 When determining the EC Action Plan be sure to include what is being
 measured, when it will be measured, and what is the acceptance standard of this
 
 measurement. 
 
 6.3.3 Common tools and principles used to make an EC successful may include trend
 
 analysis, periodic checks, surprise audits, and sampling. Table 1 below provides
 example EC Action Plans. 
 
 Table 1 
 EC Source Situation / CAPA _ | Possible EC Pla 
 Evaluate next Y tests, oar pes for next XCHontns
 Laboratory OOS created CAPA of method change. 
 to see if the problem occurs again. 
 An SOP is not followed. CAPA revised the SOP 
 Evaluate the use of the SOP for the next X months
 to make it easier to understand and retraining 
 to see if the problem occurs again. 
 completed. 
 Finished product bottles failed leak test due to Evaluate leak test results of bottles passed through
 capper problem. Instrument serviced and repaired. serviced capper for Y months to confirm repairs.
 
 
 

[SOP 

 Standard Operating Procedure SOPNo | Rev 
 QS-113 1 Page 5 of 6 
 Effectiveness Checks (EC) 
 
 6.4 EC Closure Summary on QS-113-F2 Effectiveness Check (EC) Closure 
 
 6.4.1 The Closure Summary on form QS-113-F2 Effectiveness Check (EC) Closure is
 
 a description of how and when the actions described in the EC Plan were
 completed and verify whether the corrective or preventative action was
 
 implemented, documented, and had accomplished the intended purpose.
 
 6.5 Effectiveness Check Assignment / Closure 
 
 6.5.1 Initiate/assign an effectiveness check by submitting form QS-113-Fl
 
 Effectiveness Check (EC) Assignment to DC. 
 
 6.5.2 Close an effectiveness check by submitting form QS-113-F2 Effectiveness
 
 Check (EC) Closure to DC. 
 
 6.6 Additional Requirements from QS-112 Core Quality Systems and Quality Events
 
 6.6.1 This procedure is considered a Core Quality System (CQS) that is also
 controlled by the CQS and Quality Events SOP (QS-112). 
 
 6.6.2 The term “event” is a generic reference to any of the CQS covered by SOP QS-
 112 Core Quality Systems and Quality Events. The term “event” is used
 
 interchangeably with specific CQS events as applicable (i.e. “effectiveness
 
 check” here). 
 
 6.6.3 SOP QS-112 Core Quality Systems and Quality Events provides instructions
 
 common to all Ion Labs CQS including the following topics which are not be
 duplicated here: 
 
 6.6.3.1 Assignment of unique event numbers (i.e. Effectiveness Check
 numbers) 
 
 6.6.3.2 Logging of events with Document Control 
 
 6.6.3.3 Assignment of event due dates 
 
 
 

[SOP 

 Standard Operating Procedure SOPNo | Rev ecakuht 
 Effectiveness Checks (EC) 
 QS-113 1 age 6 0 
 
 6.6.3.4 Event due date extensions 
 
 6.6.3.5 Event cancellation 
 
 6.6.3.6 Event Revision / Amendment 
 
 6.6.3.7 Monitoring of open events 
 
 6.6.3.8 Record management and retention instructions 
 
 6.7 Documentation Maintenance 
 
 6.7.1 All completed risk assessment forms will be maintained as outlined in SOP C-
 501 Document Control and SOP C-502 Record Storage, Retention, and
 
 Destruction. 
 
 6.7.2. When applicable, completed risk assessment forms will be filed with the related
 
 subject source document (i.e. deviation, OOS, complaint). 
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 12/30/19 | New procedure. N/A K. Burris | - | - |
| 1 | 09/19/23 | Scheduled review: updated document format. Added document CC- maintenance requirements and references. | 23-0471 | K. Burris |

 
 

[SOP 

 ION Effectiveness Check (EC) Assignment 
 
 NLuatbrsi tional Form: QS-113-F1 CCR No. CC-23-0472 Revision: 1 
 
 EVENT INFORMATION 
 
 Effectiveness Check Number 
 Effectiveness Check Title / 
 Description 
 
 EC Source / Reference 
 (i.e. CAPA #, DEV #, INV#, Etc.) 
 
 DATE INFORMATION 
 Open Date | | Due Date | ‘| 
 
 EFFECTIVENESS CHECK — OWNER (I.E. ASSIGNED TO) 
 
 EFFECTIVENESS CHECK PLAN / COMMENTS 
 CL] N/A O 
 
 Approval Signatures 
 Name Title Signature Date 
 Completed By: 
 (Initiator) 
 Assignment Accepted By: 
 C1 N/A if same as completed by 
 Approved By: 
 (Quality) 
 
 
 

[SOP 

 ION Effectiveness Check (EC) Closure 
 Nutritional 
 Labs Form: QS-113-F2 CCR No. CC-23-0472 Revision: 1 
 
 EVENT INFORMATION 
 Effectiveness Check 
 Noinber Revision # 
 
 Effectiveness Check 
 Title / Description 
 
 DATE INFORMATION 
 Closed Date 
 
 CLOSURE SUMMARY 
 Include as applicable: Evidence and/or statement of closure, cross references to supporting documentation,
 general conclusions / outcome, etc. 
 
 EC FINAL STATUS 
 
 E (] F F F E ou C n T d I V as E No further Action Required 
 Issue additional events here (i.e. New CAPA, EC, etc.) 
 CL] Found as 
 NOT EFFECTIVE 
 
 Issue additional events here (i.e. New CAPA, EC, etc.) 
 (] Found as 
 INCOMPLETE 
 
 Approval Signatures 
 Name Title Signature Date 
 Completed By: 
 (Initiator) 
 Approved By: 
 (Quality)