RUBYA DESIGNATED DISTRICT HOSPITAL LABORATORY

Document Title: Identification and Control of Non-conformances Procedure

Document No. PR -GM 09 Effective Date: 20/06/2020
Version 4 Revision 5
Section: Management Control Copy No. 0

RUBYA DESIGNATED DISTRICT HOSPITAL

LABORATORY

Identification and Control of Non-

Conformances Procedure
(PR-GM 09)

Name Title Signature Date

Written by: Wilfrid Paschal Quality officer 16/06/2020
Rugarabamu
Reviewed by: Fulgence Donatian Laboratory Manager 18/06/2020
Ruharara
Approved by: Dr.Fr Leodigard Mwesiga Medical Officer In 20/06/2020
charge/ Laboratory
Director

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 RUBYA DESIGNATED DISTRICT HOSPITAL LABORATORY
Document Title: Identification and Control of Non-conformances Procedure
Document No. PR -GM 09 Effective Date: 20/06/2020
Version 4 Revision 5
Section: Management Control Copy No. 0

1.0 Purpose and Scope

1.1 This procedure ensures that all non-conformities (NC) are timely identified and
resolved.

2.0 Responsibility
2.1 The Quality Officer and Laboratory Manager are responsible for implementing and
maintaining this procedure.

3.0 Activity Description

3.1 Identification of Non-conformances
3.1.1 Non-conforming activities occur in many different areas and can be
identified in many different ways including clinician’s complaints, quality
control failures, instruments calibrations, checking of consumable
materials, staff comments, reporting and calibration certificate checking,
laboratory management reviews, internal and external audits and TAT
monitoring.

3.1.2 If non-conformity is identified, the person who identifies the non-

conformity completes the Non Conformance and Corrective Action Form
(FM 018) and shall be responsible to determine and carry out the
immediate action suitable for the problem identified to contain the
problem.

3.1.3 The person who identifies the non-conformity shall present to the
Laboratory Manager or Quality Officer the completed Non Conformance
and Corrective Action Form (FM 018).

3.1.4 The Quality Officer shall record the nonconformance on the Non
Conformance Register (FM 017) and assign it with the sequential number.

3.1.5 The Laboratory Manager or Quality Officer will assign personnel to

investigate and complete the non-conformance and will agree on the date
of the follow up for completion of Corrective actions and the effectiveness
of these actions.

3.1.6 The Quality Officer will carry out an investigation to establish the medical
significance of the non-conformance and classify it as major or minor. The
results of this activity shall determine whether the following actions can be
done.

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 RUBYA DESIGNATED DISTRICT HOSPITAL LABORATORY
Document Title: Identification and Control of Non-conformances Procedure
Document No. PR -GM 09 Effective Date: 20/06/2020
Version 4 Revision 5
Section: Management Control Copy No. 0

3.1.6.1 Stopping testing of affected examination;

3.1.6.2 Withholding results or output of the activity of the affected test
examination / processes, and ordering a repeat;
3.1.6.3 Recalling result of the previous test (if necessary) or order requests
again, that may have been affected;
3.1.6.4 The Laboratory Manager or Quality Officer notifies clients or
individuals concerned if the results or processes output have been
issued;

3.1.7 The corrective action shall be conducted following the Corrective Action
Procedure (PR-GM 10).

3.1.8 The Laboratory Manager / Quality Officer or the assigned personnel will
document corrective action and record on the Non Conformance and
Corrective Action Form (FM 017).

3.1.9 The Quality Officer or Laboratory Manager will report all the non-
conformances in the Laboratory Departmental Meeting and the meeting
shall agree on the timelines for resolution of the non-conformances and its
closure and monitoring of effectiveness.

3.1.10 Resumption of work can be authorized by the Quality Officer or Laboratory

Manager following satisfactory root cause analysis and corrective action;
and communication shall be made thereof.

3.1.11 Technical non-conformances shall be solved by personnel in the respective

sections and records thereof shall be kept in the respective sections.

3.2 Supporting documents

1. Non Conformance and Corrective Action Form (FM 018)
2. Corrective Action Procedure (PR-GM 10)
3. Non Conformance register (FM 017)

6. REFERENCES
6.1. ISO 15189: Medical laboratories — Particular requirements for quality and
competence (2012) International Organization for Standardisation.

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 RUBYA DESIGNATED DISTRICT HOSPITAL LABORATORY
Document Title: Identification and Control of Non-conformances Procedure
Document No. PR -GM 09 Effective Date: 20/06/2020
Version 4 Revision 5
Section: Management Control Copy No. 0

7. RECORDS
Record title Record ID Custodian/location
Non-conformance-Corrective action Form FM 018 Section head and QO
Non Conformance Log FM 017 QO

8. AMENDMENT RECORD
[Enter any changes that are done on this procedure]
NAME DATE SUMMARY OF CHANGES
Idefonce Mkingule 27/12/2017 Reviewed the whole procedure to comply with
ISO15189, 2012 version requirements
Wilfrid Paschal 30/07/2019 Reviewed the whole procedure to comply with
Rugarabamu ISO15189, 2012 version requirements
Wilfrid Paschal 20/06/2020 The documents prepared by quality officer, instead of
Rugarabamu safety officer, reviewed by laboratory manager instead of
quality officer and authorized by lab. director instead of
laboratory manager

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 RUBYA DESIGNATED DISTRICT HOSPITAL LABORATORY
Document Title: Identification and Control of Non-conformances Procedure
Document No. PR -GM 09 Effective Date: 20/06/2020
Version 4 Revision 5
Section: Management Control Copy No. 0

I, acknowledge that I have been trained, read, understood and agree to follow the procedure
as documented:

No Name Signature Date

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