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(11-COPY) SSOP4.11-001-Procedure For Preventive Action

This document provides guidelines for preventive actions to avoid non-conformities at a laboratory center. It outlines reviewing documents, monitoring quality controls, equipment maintenance and audits to detect trends. When issues are found, the root cause is determined and preventive actions are taken.

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Takele Oli
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31 views

(11-COPY) SSOP4.11-001-Procedure For Preventive Action

This document provides guidelines for preventive actions to avoid non-conformities at a laboratory center. It outlines reviewing documents, monitoring quality controls, equipment maintenance and audits to detect trends. When issues are found, the root cause is determined and preventive actions are taken.

Uploaded by

Takele Oli
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Adama Public Health Research and

Referral Laboratory Center

Procedure for Preventive Action

Name Position Signature Date

Compiled by Mr. Bedada Teshome Laboratory expert 06/03/2007E.C

Ms. Tizita Tsegaye Quality Manager 06 /03/ 2007E.C

Reviewed by Haile Benti Quality Manager July 18, 2021 GC

Approved by Mr. Daba Mulleta CEO August 2, 2021 GC

Effective Date: August 9, 2021 Version No. 05


Document No: SSOP4.11-001 Copy No.

Page 1 of 6
Adama Public Health Research and Document No: SSOP4.11-001
Referral Laboratory Center Version No: 05
Page 2 of 6
Procedure for Preventive Action Effective Date: August 9, 2021 GC

REVISION AND AMENDMENT


A. Annual Review of Document
Revision No Review Date Reviewed by: Approved by:
Name Signature Name Signature
05 July 18, 2021 Haile Benti Daba Mulleta

B. Version Change History/Description


Version Effective Description of Version Change Name & Signature Name & Signature of
No Date of Reviewer Approval

C. Amendment
Rev. Page Description of Amendment Amendment Effective Date Name &
No. No Date Signature of
approval
Aligned procedure to new format according 06/03/ 2007E.C 06/03/ 2007E.C
to document control procedure version 2
Quality assurance department changed to all 05/04/2009 E.C 05/04/2009 E.C
section
1. Name and logo of the organization changed July 18, 2021 GC August 9, 2021 GC
from OPHRCBQAL to APHRRLC
2. The position ‘Laboratory director’ named as
Chief Executive Officer (CEO)
July 18, 2021 GC August 9, 2021 GC
The amendment sheet at the end of the
document has omitted and the amendment of
Adama Public Health Research and Document No: SSOP4.11-001
Referral Laboratory Center Version No: 05
Page 3 of 6
Procedure for Preventive Action Effective Date: August 9, 2021 GC

the 2nd page of the document replaced

July 18, 2021 GC August 9, 2021 GC


Document numbering system has changed
according to Version 5 of document Control
SOP
Adama Public Health Research and Document No: SSOP4.11-001
Referral Laboratory Center Version No: 05
Page 4 of 6
Procedure for Preventive Action Effective Date: August 9, 2021 GC

1. Purpose

The purpose of this procedure is to provide guidelines on the various actions to be taken in order
to prevent non-conformities from occurring. The procedure outlines pro-active measures to guard
against any non-conformity. The common feature amongst all preventive actions outlined below
is that they all involve trend analysis. Detecting undesirable trends before a problem actually
arises is the idea behind preventive action.

2. Scope

This procedure is applicable to all sections of APHRRLC.

3. Abbreviation

APHRRLC-Adama Public Health Research Referral Laboratory Center

EQA- External Quality Assessment

4. Responsibility

The quality manager and section focal persons share the responsibility of ensuring that this
procedure is effectively implemented.

5. Definitions

Preventive action: It is a pro-active process for identifying opportunities for improvement rather
than a reaction to the identification of problems or complaints

6. Activity description

1. All documentation forming the quality management system of APHRRLC is reviewed


every 2 years or whenever the need arises to ensure they continue to be suitable.
Identification of any obsolete or incorrect information in the documents helps to prevent
non-conformities.
2. Data from internal quality controls is reviewed daily by technical staff to detect any
undesirable shifts and/or trends (refer to procedure for reviewing internal quality
controls-SSOP5.6-001)
3. Temperature for refrigerators and other equipment as well as room temperatures are
plotted and monitored on daily basis by technical staff to detect any undesirable shifts
and/or trends.
Adama Public Health Research and Document No: SSOP4.11-001
Referral Laboratory Center Version No: 05
Page 5 of 6
Procedure for Preventive Action Effective Date: August 9, 2021 GC

4. Performance of internal quality controls and temperature charts are also reviewed by the
respective section focal person on a monthly basis.
5. Results of external quality assessment are reviewed for shifts and trends to identify any
potential non-conformity by quality manager, section focal person and lab expert who
perform EQA. (Refer to procedure for external quality assessment-SSOP5.6-002).
6. Preventive maintenance of equipment is planned by section focal person and
implemented by lab experts on daily, weekly, monthly and/or quarterly basis as per
manufacturer’s instructions/recommendations
7. If undesirable trends and/or shifts are detected from any of the measures stated in points 1
to 6, action is taken to prevent a possible non-conformity from occurring.
8. The 5 ‘Ms’ which contribute to the quality of a laboratory result are investigated as part
of troubleshooting undesirable trends. These are Manpower, Machines, Mileu
(environment), Materials and Methods.
NB: Equipment manuals are used when investigating equipment failure.
9. When the root cause has been identified, preventive action is taken.
10. When internal audits are done, internal auditor pay attention to preventive action taken to
ensure effectiveness of preventive action.
11. If Potential nonconformities is identified APHRRLC uses Root cause analysis process
model (JA4.10-001) and Root cause tools (JA4.10-002) to prevent the nonconformities.
The individual Potential nonconformities will registered on nonconformity form and
evaluated for trends and frequencies which will be an input for annual management
review

7. References

• ISO 15189:2012. Medical laboratories – Particular requirements for quality and


competence

8. Supporting documents

• Nonconformity report form-SF4.9-001


• Nonconformity Register form-SF4.9-002
• Internal Quality Control Procedure-SSOP5.6-001
• External Quality Assessment Procedure-SSOP5.6-002
• Root cause analysis process model-JA4.10-001
• Root cause analysis tool-JA4.10-002
Adama Public Health Research and Document No: SSOP4.11-001
Referral Laboratory Center Version No: 05
Page 6 of 6
Procedure for Preventive Action Effective Date: August 9, 2021 GC

I have read, understood and agree to follow the procedure as documented:

No Name Signature Date

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