MINISTRY OF HEALTH

SOP Title: : Corrective Action/ Preventive Action SOP Version 1

SOP No: LGEN. 0025

XXX County.
Standard Operating Procedure. SOP No: LGEN.
Facility:………………………….. Version: 1.
Supercedes: N/A
Effective Date:

Title: Corrective Action/ Preventive Action.

NAME. SIGNATURE. DATE.

PREPARED BY.

REVIEWED BY.

APPROVAL
AUTHORITY.

NOTE: This is a CONTROLLED document. Any documents that are not stamped in red “APPROVED” are not controlled.
Anyone using an uncontrolled copy is responsible for checking that they have the latest revision of the document prior to use.
 MINISTRY OF HEALTH

SOP Title: : Corrective Action/ Preventive Action SOP Version 1

SOP No: LGEN. 0025

1.0 PURPOSE / INTRODUCTION:

1.1 Laboratory policies and operational documentation provides the guidelines when
non-conforming work or deviation from policies, procedures, quality system or
technical operations have been identified.
1.2 The Director or designee controls Laboratory quality management.
1.3 Initiation of corrective action procedures whenever an indication of non-
conformance to the laboratory policies are observed or reported is the responsibility
of every laboratory personnel.
1.4 Corrective actions should be accompanied by preventive actions where applicable
1.5 Corrective actions should be closed every time the concern is addressed to its
completion.
1.6 The initiator can be the personnel who identifies the deficiency and should be
closed by the point where the deficiency occurred
1.7 Corrective action documentation should be thought of as a system to prevent and
control errors that occur through the pre-analytic, analytic and post analytic
processes and not as a punitive action.
1.8 The allegation of deficiency, causation review, findings and respective corrective
action is the subject of a Corrective Action Report sent through channels from the
bench to the Laboratory Manager or designee.

2.0 SCOPE / RESPONSIBILITY:

2.1 This SOP applies to all laboratory personnel and other departments that use the
laboratories services.
2.2 It is the responsibility of the designated of the County Leads, Quality Assurance
and Quality Control (QC/QA) personnel, Laboratory Supervisors to ensure that the
current SOP is available to the Health Care Workers and the procedure is followed
as documented.

3.0 SAFETY/RISK ASSESSMENT:

NA.

4.0 DEFINITIONS:
4.1 SOP - Standard Operating procedure

4.2 QC - Quality Control

4.3 QI - Quality Improvement

4.4 QA/QC - Quality Assurance

4.5 CA - Corrective Action

NOTE: This is a CONTROLLED document. Any documents that are not stamped in red “APPROVED” are not controlled.
Anyone using an uncontrolled copy is responsible for checking that they have the latest revision of the document prior to use.
 MINISTRY OF HEALTH

SOP Title: : Corrective Action/ Preventive Action SOP Version 1

SOP No: LGEN. 0025

5.0 SPECIMEN:
NA

6.0 EQUIPMENT/ MATERIALS/ REAGENTS:

6.1 Equipment.
NA
6.2 Materials.
Corrective Action/ Preventive Action (Appendix 8.1)
6.3 Reagents.
NA

7.0 METHODOLOGY:
7.1 On identification of a variance the personnel will retrieve a blank CAPA form
(Appendix 8.1) from the CAPA folder and initiate the documentation.

7.2 He/she will determining causation as an important first step in the corrective action
procedure.

7.3 A process review will include technical procedures, equipment and employee
performance are imperative.

7.4 These deviations include but are not limited to:-

7.4.1 QC failure;

7.4.2 PT failure;

7.4.3 customer complaint;

7.4.4 sample mishandled by lab;

7.4.5 instrument malfunction;

7.4.6 reporting error,

7.4.7 deviation from procedure,

7.4.8 Client/Clinics complaint

7.5 Variance may be classified as QC failure; PT failure; customer complaint; sample

mishandled by lab; instrument malfunction; reporting error, deviation from
procedure, etc.

NOTE: This is a CONTROLLED document. Any documents that are not stamped in red “APPROVED” are not controlled.
Anyone using an uncontrolled copy is responsible for checking that they have the latest revision of the document prior to use.
 MINISTRY OF HEALTH

SOP Title: : Corrective Action/ Preventive Action SOP Version 1

SOP No: LGEN. 0025

7.6 The Log number is used to ensure all CAs are uniquely identified. Filing records by
Log number is recommended;

7.7 The section supervisor then Laboratory Manager or designee should be notified and
should review the corrective action process and documentation.

7.8 The QA Manager or designee will provide follow- up until the corrective action is
closed with documentation/evidence of completion

7.9 Once corrective action has been completed, periodic monitoring by the QA unit for
continued compliance is required.

7.10 Where applicable, the CAPA should stay OPEN for a sufficient time to ensure all
stated actions were taken and address/solve the initial issue.

7.11 All corrective action reports are maintained in the Laboratory Corrective and
Preventive Action folders, which are kept by every section.

7.12 All corrective action forms documented are discussed on the scheduled meetings
and summarized during the monthly Quality Improvement meeting.

NOTE: This is a CONTROLLED document. Any documents that are not stamped in red “APPROVED” are not controlled.
Anyone using an uncontrolled copy is responsible for checking that they have the latest revision of the document prior to use.
 MINISTRY OF HEALTH

SOP Title: : Corrective Action/ Preventive Action SOP Version 1

SOP No: LGEN. 0025

8.0 APPENDICES:
8.1 Corrective Action Preventive action (CAPA) form

CORRECTIVE ACTION AND PREVENTIVE ACTION (CAPA) FORM

LABORATORY NAME:
DEPARTMENT OR ANALYSIS TYPE:
VARIANCE CLASS / CATEGORY: LOG #
Examples: QC failure; PT failure; customer complaint; sample mishandled by lab; instrument malfunction; reporting
error, deviation from procedure, etc. The log number is a unique identifier assigned by the laboratory.
INITIATED BY (Name) (Signature)
(Date) (Time) :
NOTIFIED SUPERVISOR (Name) (Signature)
(Date) (Time) :
EVENT DESCRIPTION:
Fully describe the problem or the nonconforming event or analysis result. Attach any documentation that supports
and/or supplements this description. (If PT Failure, attach copy of PT report.)
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
____________________________ ______P.T.O
INVESTIGATION STEPS:
Indicate the response(s) to the non-conformance, including the immediate CORRECTION taken, all processes or raw
data reviewed, QA or Management staff notified, analysis repeated, analysis halted, etc. (Include details of staff
member notified, date and time of notification, customer or outside involvement, analysis data, etc.)
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________
_P.T.O
PREVENTIVE ACTION:
Action to prevent recurrence: SOP revision, staff training, purchase of standards or equipment, document/form
revision, etc.
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
________________________________________________________ ________P.T.O

Submitted by: (Name) (Signature)

(Date)
QA review and approved: (Name) (Signature)
(Date)

NOTE: This is a CONTROLLED document. Any documents that are not stamped in red “APPROVED” are not controlled.
Anyone using an uncontrolled copy is responsible for checking that they have the latest revision of the document prior to use.
 MINISTRY OF HEALTH

SOP Title: : Corrective Action/ Preventive Action SOP Version 1

SOP No: LGEN. 0025

Supervisor or Manager: (Name) (Signature)

(Date)
CAPA Closed by QA Manager: (Name) (Signature)
(Date)

Description conti’

Investigation conti’

Preventive action conti’

9.0 REFERENCES:

NOTE: This is a CONTROLLED document. Any documents that are not stamped in red “APPROVED” are not controlled.
Anyone using an uncontrolled copy is responsible for checking that they have the latest revision of the document prior to use.
 MINISTRY OF HEALTH

SOP Title: : Corrective Action/ Preventive Action SOP Version 1

SOP No: LGEN. 0025

NA

10.0 DOCUMENT CHANGE HISTORY:

10.1 Version Table:
Version 1:. Dated: SOP No. Pages:

Version 2: Dated: SOP No.: No. Pages:

Version 3: Dated: SOP No.: No. Pages:

10.2 SOP Review Log.

Date of Changes made. Name of reviewer. Signature.
review.

11.0 SOP AWARENESS LOG.

I, the under named, have read and understand the contents of this SOP. I agree to
NOTE: This is a CONTROLLED document. Any documents that are not stamped in red “APPROVED” are not controlled.
Anyone using an uncontrolled copy is responsible for checking that they have the latest revision of the document prior to use.
 MINISTRY OF HEALTH

SOP Title: : Corrective Action/ Preventive Action SOP Version 1

SOP No: LGEN. 0025

contact my supervisor/ designee if I have any query.

NO. DATE NAME SIGNATURE

NOTE: This is a CONTROLLED document. Any documents that are not stamped in red “APPROVED” are not controlled.
Anyone using an uncontrolled copy is responsible for checking that they have the latest revision of the document prior to use.