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Quality Procedures and Forms 2016

This document outlines procedures for controlling documents at a university. It defines key terms related to document control and identifies responsibilities. The procedures describe how to create, revise, approve, distribute and maintain internal documents. It also covers registering documents, stamping document copies, and controlling external documents. The goal is to ensure appropriate versions of documents are identified and made available where needed.

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Mohammed Musa
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100% found this document useful (9 votes)
1K views30 pages

Quality Procedures and Forms 2016

This document outlines procedures for controlling documents at a university. It defines key terms related to document control and identifies responsibilities. The procedures describe how to create, revise, approve, distribute and maintain internal documents. It also covers registering documents, stamping document copies, and controlling external documents. The goal is to ensure appropriate versions of documents are identified and made available where needed.

Uploaded by

Mohammed Musa
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
You are on page 1/ 30

QUALITY procedures

And forms

2016
procedures
Page No.: Page 1 of 5
Control of Documents
Revision No.: 0
CNU-QP-01 Quality Procedure Effectivity:

1.0 PURPOSE:

1.1 This document aims to define the policies and procedure for controlling and
maintaining the University documents, to ensure that appropriate versions are
identified and made available at point of use.
1.2 This procedure aims to ensure that documents of external origin are identified
and their distribution, controlled.

2.0 POLICY

It is the policy of the University to ensure that pertinent documents are properly
identified, updated, approved, and made available at points of use. Also, it is the
policy of the University to ensure that documents of external origin are identified
and controlled during distribution.

3.0 DEFINITION OF TERMS:

3.1 Controlled Copy – Reproduced copy of the original document, latest issued
document; indicated by blue “Controlled Copy” stamp

3.2 Documents – as referred to in this procedure, are QMS quality procedures,


standard operational instructions, the Quality Manual, and other procedures/
standard/form indicated in the Document Master list

3.3 Document Controller (DC) – Individual/s assigned to oversee the


implementation of the Document Control procedure

3.4 Document Custodian – Officer or staff assigned to maintain controlled copies


of documents

3.5 Document Master list – A list of the documents being controlled by a


Document Controller in terms of creation, approval, revision, distribution,
access, and use

3.6 DFF – Document Feedback Form. A form used to suggest any revision to an
existing document or manual.

3.7 External Documents – Documents generated from external sources

3.8 Internal Documents – Documents generated from QMS implementation and


relevant to the university operations

3.9 Obsolete Copy – Superseded document, indicated by red “Obsolete Copy”


stamp

Nature of Revision: Document Distribution:


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Control of Documents
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CNU-QP-01 Quality Procedure Effectivity:

3.10 Original Copy – Original document bearing approvals in blue ink, maintained
by the DC

3.11 Originator/Process Owner – Person who initiated document creation/revision


who shall fill-out the “Prepared by” portion of the document

3.12 Uncontrolled Copy – Reproduced copy of a controlled copy document strictly


for reference use, indicated by blue “Uncontrolled Copy” stamp

4.0 SCOPE:

4.1 This procedure applies to all documents required by the UNIVERSITY’s


Quality Management System as indicated in the Document Master list.

4.2 This procedure also covers the monitoring and/or distribution of externally
generated documents.

5.0 RESPONSIBILITIES:

5.1 PA for Quality Assurance – Reviews the established procedures in line with
the requirements complied by the University and recommends the same for
approval and implementation.

5.2 Document Controllers – Ensures that all documents are properly identified,
updated, approved and made available at relevant areas for use. The DC is
also responsible for the maintenance and implementation of this procedure
on Control of Documents.

5.3 Document Custodians – Coordinates the implementation of this procedure


within their respective group or center. Ensures that obsolete documents are
identified and prevented from unintended use.

6.0 PROCEDURE DETAILS:

Ref.
Key Activities Responsibilities
No.
6.1 Creation/revision and identification of documents Originator
6.2 Review and acceptance of draft documents Concerned Officer/ Process Owner
6.3 Approval of documents PA for QA
6.4 Registration and stamping of documents Document Controller
6.5 Distribution of approved documents Document Controller
6.6 Maintenance of Controlled Copies Document Custodians
6.7 Document Revision/Updating Originator
6.8 Control of External Documents Document Custodians
6.9 Control of Electronic Document Document Controller

Nature of Revision: Document Distribution:


Page No.: Page 3 of 5
Control of Documents
Revision No.: 0
CNU-QP-01 Quality Procedure Effectivity:

6.1 Creation/Revision and Identification of Documents

If a need to create/revise a document arises, the Document Feedback Form


(DFF) is used. An Originator prepares the DFF, together with the draft
document. Draft documents shall be labeled (watermark, if possible) with the
word “DRAFT” and should not be used in operations unless it is officially
approved. The Originator may obtain a document code from the DC to initially
identify/classify the document according to the established document coding
system.

6.2 Review and Approval of Documents

Upon preparation of the DFF and Draft Documents, these are routed to the
concerned officer/process owner for review and acceptance. After the review,
said officers/process owners endorse the draft document, together with the
accomplished DFF, to the PA for QA for approval. Approved documents bear
the signature of approving authorities in blue ink.

6.3 Registration and Stamping of Documents

6.3.1 Upon approval of the document, the DC confirms the revision of the
document or assigns a new unique identification number according to
the following classification:

a. Quality Manual - CNU-QM


b. Quality Procedure - CNU -QP-XX
c. Standard Operational Instruction - CNU -SOI-XX
d. Form - (CNU)-SOP/QP-XX Fnn

note: xx and nn are series numbers starting with 01

6.3.2 Project-related policies follow the existing numbering system supplied by


the office.

6.3.3 The DC enters the details, of the document, in the Document Masterlist
and keeps the master copy. The DC reproduces the master copy
according to the number of custodians specified in the Distribution List.
All copies of the document are stamped with “Controlled Copy” in blue
ink prior to distribution.

6.3.4 Document Control Stamps are maintained and used by the Document
Controller.

Nature of Revision: Document Distribution:


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Control of Documents
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CNU-QP-01 Quality Procedure Effectivity:

6.4 Distribution and Maintenance of Controlled Copies

6.4.1 Distributed controlled copies of documents are recorded in the


Document Distribution List by the DC. Upon receipt, the Document
Custodian initials the controlled copy of document, in blue ink, and signs
on the Distribution List.

6.4.2 If other than the controlled copy, a copy of the document is requested,
said request is approved by the Document Controller. If approved, the
Document Custodian may reproduce a “controlled copy” and stamp the
copy with “Uncontrolled Copy”, in blue ink, prior to release or distribution.
The recipient initials the uncontrolled copy in blue ink.

6.5 Document Modification/Revision/Update

6.5.1 If there is a need to update, modify, or revise a QMS document, the DFF
is used. Changes made to the document are typed in italics for easy
identification. The nature of revision is reflected in the “Nature of
Revision” portion of the document page. If about 50% or more of the
pages is affected by revision/change, the revision/change is classified
as “Complete Rewrite”. In such case, revision number of all pages of
the document shall follow the highest revision number of that document.

6.5.2 Review and approval of a revised document follow the guidelines set
under Section 6.2 of this procedure. The Document Controller updates
the Revision History page, which forms part of each document.

6.5.3 Upon distribution of the revised/updated document, obsolete copies are


retrieved and stamped with “Obsolete Copy” in red ink. The Document
Controller maintains the latest original copy of the obsolete document.
Obsolete controlled copies are disposed in accordance with the
procedure on Control of Records.

6.6 Control of Externally-Generated Documents

6.6.1 Document Controller/s use the External Document Distribution List to


register and monitor the receipt and distribution of externally generated
documents.

6.6.2 Recording is done immediately upon receipt and turnover of documents


to concerned unit and/or individual. The responsibility for the
maintenance and updating of the External Document Distribution List is
entrusted to the College/Department/Division/Unit. Externally
generated documents received through e-mail are likewise recorded in
the External Document Distribution List.

Nature of Revision: Document Distribution:


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Control of Documents
Revision No.: 0
CNU-QP-01 Quality Procedure Effectivity:

6.7 Electronic Copies of Documents

6.7.1 Electronic copies of documents are not used as reference for


implementation since there is no assurance of being the latest version
of the document. Electronic files of Original Copies are edited, copied,
and printed only by the Document Controller to protect from
unauthorized copy and use.

6.7.2 The Document Controller authorizes uploading and downloading of


documents onto and from the intranet. Access to controlled documents
available in the intranet is regulated through the use of an access code
and password provided by the DC. Access to controlled documents
available in the intranet may be extended to other users.

7.0 REFERENCES:

7.1 CNU-QP-02 - Control of Records


7.2 CNU -QP-01 F01 - Document Masterlist
7.3 CNU -QP-01 F02 - External Document Distribution List
7.4 CNU -QP-01 F03 - Document Distribution List
7.5 CNU -QP-01 F04 - Document Feedback Form

Nature of Revision: Document Distribution:


Page No.: Page 1 of 4
Control of Records
Revision No.: 0
CNU-QP-02 Quality Procedure Effectivity:

1.0 PURPOSE:

This document aims to define and provide the controls needed in the use, maintenance,
and disposal of records.

2.0 POLICY

To ensure conformity to the requirements and ensure effective operation of the CNU’s
quality management system, it is the policy of the university to ensure that pertinent
records are established, organized, maintained, and properly disposed in accordance with
the guidelines provided in the control of records.

3.0 DEFINITION OF TERMS:

3.1 Active Records - Records within the active retention period


3.2 Inactive Records - Records within the inactive retention period
3.3 Records Custodian - Identified individuals from each unit held responsible for the
maintenance, filing and safekeeping of records, as indicated
in the
Records Matrix.

4.0 SCOPE:

4.1 This procedure applies to all records related to QMS and CNU operations, which are
indicated in the Records Matrix.
4.2 This procedure also covers the handling of externally generated data during execution
of SOP/SOIs, as well as, those data provided by clients/customers.

5.0 RESPONSIBILITIES

5.1 Quality Management Representative - ensures that the Records Custodians


adhere to the requirements of this
procedure.
5.2 Designated Officers - ensure that the data and information
provided are sufficient, as required in the
relevant document or form.
5.3 Records Officer - ensure that active records relative to
QMS are properly maintained.
5.4 Records Officer - is responsible for the maintenance and
disposition of inactive records.
5.5 Records Custodian - is responsible for the proper collection,
storage, protection, retrieval, retention,
and disposition of relevant or active
records.

Nature of Revision: Document Distribution:


Page No.: Page 2 of 4
Control of Records
Revision No.: 0
CNU-QP-02 Quality Procedure Effectivity:

6.0 PROCEDURE DETAILS:

Ref. Key Activities Responsibilities


No.
6.1 General procedure
6.2 Collection and identification Records Custodian
6.3 Review and/or approval of records, as Concerned designated officer
appropriate
6.4 Storage and protection Records Custodian
6.5 Retrieval and retention Records Custodian
6.6 Disposition of current/active records Records Custodian
6.7 Maintenance and disposition of inactive records Records Custodian

6.1 General

6.1.1 Records are legible, identifiable and easily retrievable.


6.1.2 Records can be in the form of any type of media such as hard copy or
electronic file.
6.1.3 If necessary, records are reviewed and/or approved prior to issue.
6.1.4 Records indicate the person/s who authorizes its use.

6.2 Collection and Identification

6.2.1 Records are identifiable through any or combination of the following


information, as appropriate:

a. Title of Record
b. Date(s)
c. Name of signatory (ies)
d. Document Code
e. Revision status
f. Reference Document
g. Control number

6.2.2 Records are collected upon availability from their source, for appropriate filing
by the Records Custodian or concerned process owner. Only marking pens are
used on records. Pencil markings are avoided and may be considered unofficial.

6.2.3 In case of erasure or correction, the corrected data bears the initials of the
person who corrected it.

For example: 6312 7564 ADK

6.3 Review and Approval of Records

6.3.1 Some records require the signature of authorized individuals. The reviewer
ensures that said records are legible and contain sufficient information as basis
for its endorsement or approval. Hence, some records without the signature of
approving authorities may be treated “unofficial.”
Nature of Revision: Document Distribution:
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Control of Records
Revision No.: 0
CNU-QP-02 Quality Procedure Effectivity:

6.4 Storage and Protection

6.4.1 Records are kept in appropriate locations to minimize physical deterioration,


damage, and loss. As such, records may be protected in accordance with the
following:

a. Use of expanded folders, protective sheets, and/or ring binders;


b. Stored in shelves or steel cabinets to prevent from deterioration;
c. Regular back-up of e-files; and,
d. Access restriction, through password to prevent from unauthorized use.

6.5 Retrieval and Retention

6.5.1 To ensure easy retrieval, filing cabinets, shelves, boxes, folders, and envelopes
are labeled according to the established filing system. Likewise, a Records
Matrix is maintained indicating information, such as: Record Title, Retention
Period and Record Custodian for both active and inactive records.
6.5.2 Records, borrowed by other offices or workgroups, are traced using logbooks or
log sheets.

6.6 Maintenance and Disposal

6.6.1 Maintenance and disposal of records are done in accordance with the Records
Matrix. Turnover of inactive records as scheduled and recorded in a specific
logbook of the concerned individual or office.
6.6.2 For easier safekeeping, permanent records may be converted to e-files, except
for records that require original copy bearing authentic signatures.

7.0 REFERENCES:

7.1 See 8.0 Records Matrix

Nature of Revision: Document Distribution:


Page No.: Page 4 of 4
Control of Records
Revision No.: 0
CNU-QP-02 Quality Procedure Effectivity:

8.0 RECORDS MATRIX

RETENTION CUSTODIAN
TITLE
Active Inactive Active Inactive
Sample only….
Records Office/
TOR Upon Closure (+2yrs) Permanent PM
COO
Records Office/
Invitation to BID Upon Closure (+2yrs) Permanent PM
COO
Records Office/
Letter of Intent Upon Closure (+2yrs) Permanent PM
COO
Letter of Inquiry from Records Office/
Upon Closure (+2yrs) Permanent PM
client COO
Client Referral
Records Office/
Acceptance & Monitoring Upon Closure (+2yrs) Permanent PM
COO
Form
Inquiry Receipt and Records Office/
Upon Closure (+2yrs) Permanent PM
Endorsement Form COO
Upon Project Closure Records Office/
Contact Report (+2yrs)
Permanent PM
COO
Client Profile/ Background Upon Project Closure Records Office/
Permanent PM
Info (+2yrs) COO
Upon Project Closure Records Office/
Project Proposal (+2yrs)
Permanent PM
COO
Prescribed Project Upon Project Closure Records Office/
Permanent PM
Proposal from client (+2yrs) COO
Upon Project Closure Records Office/
Logframe (+2yrs)
Permanent PM
COO
Upon Project Closure Records Office/
Workplan (+2yrs)
Permanent PM
COO
Upon Project Closure Finance Center/ Records Office/
Finplan (+2yrs)
Permanent
Accounting COO
Upon Project Closure Records Office/
Transmittal letter (+2yrs)
Permanent PM
COO

Nature of Revision: Document Distribution:


Page No.: Page 1 of 3
Control of Nonconformity
Revision No.: 0
CNU-QP-03 Quality Procedure Effectivity:

1.0 PURPOSE

This document defines the policies and guidelines to identify and control nonconforming
products/services during the university operations and QMS scope.

2.0 POLICY

CNU shall provide services to its clients in accordance with their specified requirements.
As such, it is the policy of the university to ensure that all services that do not conform to
requirements are identified, evaluated, and resolved in accordance with the guidelines as
provided in this document.

3.0 DEFINITION OF TERMS:

3.1 NC - Nonconformity. Deviation from a specified requirement


that need immediate action.
3.2 OFI - Opportunity for Improvement. A lapse in the system that
causes minor errors or may cause potential problems in
CNU operations and therefore may need to be improved.
3.3 RFA - Request for Action form. This is used to initiate and
record the identified NC/OFI and monitor the status and
actions taken relative to the NC/OFI.
3.4 Disposition - Actions to be taken to nonconformities
3.5 Control Measures - Actions to be taken to prevent occurrence of an identified
Nonconformity

4.0 SCOPE

This document applies to all products/services provided by the university for its clients,
where nonconformities may arise during its operation or QMS scope.

5.0 RESPONSIBILITIES

5.1 QAO or any process owner/staff – Identifies the nonconformity and initiates the
control and disposition measures, in coordination with assigned Supervisor or
authorized officer. He or she Records the information/data related to nonconformity
as per Corrective and Preventive Action Procedure

5.2 QAO or any process owner/staff – Identifies nonconformities, establishes the control
methods, defines responsibilities and authorities, and reviews and approves the
necessary action to address the identified nonconformity.

Nature of Revision: Document Distribution:


Page No.: Page 2 of 3
Control of Nonconformity
Revision No.: 0
CNU-QP-03 Quality Procedure Effectivity:

6.0 PROCEDURE DETAILS

Ref.
Key Activities Responsibilities
No.
6.1 Identification of nonconformity QAO or any process owner/staff
6.2 Verification Process owner/staff
6.3 Resolution Process owner/staff
6.4 Implementation of Appropriate Action Refer to Control of Nonconformity
Matrix
6.5 Verification of Action Taken IQA Team/Department Head /
CNU Head

6.1 Identification of nonconforming products/services

Nonconforming products/services may arise, from CNU operation or QMS scope,


when deviation(s) from the following activities and/or identified documented
information during execution:

 University Code
 ARTA Documents
 SPMS Manual
 Research Manual
 Extension Manual
 Colleges’ Manual of Operations
 Student Handbook
 Faculty Manual
 Administrative Manual
 Collective Negotiation Agreement
 Other Manuals/Guidelines

Upon identification, such nonconformity are recorded using the RFA form. Refer to
(CNU)-QP-04 Corrective and Preventive Action Procedure.

6.2 Verification of Nonconformity

All documented nonconformities are referred to the QAO with the process
owner/staff, for verification and analysis of the nonconformity, using appropriate
problem solving tools/techniques. The process owner/staff, depending on the nature
of nonconformity, may initiate a meeting with concerned individuals to facilitate the
verification and identification of root cause.

6.3 Resolution of nonconformity

After problem analysis, the necessary corrective/preventive action are formulated


and recorded in the RFA form. Whenever possible, the target date for completion of
“Action to be Taken” are indicated in the RFA, as basis for the subsequent follow-up
and verification of action taken and result.

Nature of Revision: Document Distribution:


Page No.: Page 3 of 3
Control of Nonconformity
Revision No.: 0
CNU-QP-03 Quality Procedure Effectivity:

6.4 Follow-up on Action Taken

With reference to the submitted RFA, the QAO and IQA Team, may conduct follow-
ups on “action to be taken” and perform some verification to ensure that appropriate
action have been taken to address the identified nonconformity. If the implemented
resolution or control measure, to address the identified nonconformity, is found to be
more effective and/or efficient, such approach may be adopted to update the
established Control of Nonconformity Matrix. Revision of such Matrix follows the
Document Control Procedure.

6.5 The matrix below describes the disposition and/or control measures applicable to
identified NCs.

CONTROL OF NONCONFORMITY MATRIX

Nature of Nonconformity Disposition/Control Measures Responsibility


Delays on target dates for  Inform Client
deliverables  Revise Workplan

Billing errors  Retrieve the Billing Statement


 Reissue BS with covering
explanation
Inability to notify customer  Issue written
re changes in planned explanation/apologies
arrangements
Errors in publication  Publish errata
Deviation from established  Investigate
Code of Conduct  Refer to superior/ manager
for immediate appropriate
action
Documentation errors  Retrieve
 Reports  Revise
 Certificates  Resend
 Handouts
 Correspondence

7.0 REFERENCES:

7.1 CNU-QP-01 - Control of Documents


7.2 CNU-QP-04 - Corrective and Preventive Action Procedure
7.3 CNU-QP-04 F01 - Request for Action Form
7.4 CNU University Code

Nature of Revision: Document Distribution:


Page No.: Page 1 of 3
Corrective and Preventive Action
Revision No.: 0
CNU-QP-04 Quality Procedure Effectivity:

1.0 PURPOSE

This document provides the policies and procedure to initiate and record corrective and preventive
actions taken by the CNU to eliminate causes of nonconformities and support the intention of
continual improvement.

2.0 POLICY

The delivery of the university’s products and services necessitates that specified requirements of
customers/clients are satisfied in accordance with service agreement. As such, it is the policy of
the university to identify, control and prevent recurrence/occurrence of products/services that do
not conform to specified requirements. It is likewise the policy of the university to implement
corrective and preventive actions to continually improve the effectiveness of the established
quality management system.

3.0 DEFINITION OF TERMS:

3.1 NC - Nonconformity. Deviation from a specified requirement that need


immediate action.
3.2 OFI - Opportunity for Improvement. A lapse in the system that causes
minor errors or may cause potential problems in the university
operations and therefore may need to be improved.
3.3 Corrective Action - Action to eliminate the cause of a detected NC/OFI or other
undesirable situation. Corrective action is taken to prevent
recurrence. There can be more than one root cause for a
NC/OFI.
3.4 Preventive Action - Action to eliminate the cause of a potential nonconformity or
other undesirable situation. Preventive action is taken to prevent
occurrence. There can be more than one root cause for a
NC/OFI.
3.5 RFA - Request for Action form. This is used to initiate and record the
identified NC/OFI and monitor the status and actions taken
relative to the NC/OFI.
3.6 Initiator - An CNU officer or staff who initiated the RFA.
3.7 IQA - Internal Quality Audit. A procedure to evaluate the effectiveness
of the QMS.

4.0 SCOPE

This procedure covers all corrective and preventive actions identified when nonconformity is
encountered/anticipated through internal audits, customer complaints, problems
encountered/anticipated during CNU operation or QMS scope and any event that could affect the
QMS.

Nature of Revision: Document Distribution:


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Corrective and Preventive Action
Revision No.: 0
CNU-QP-04 Quality Procedure Effectivity:

5.0 RESPONSIBILITIES

5.1 The Quality Management Representative is responsible for ensuring the proper
implementation of this procedure.
5.2 The Heads ensure that appropriate actions are carefully reviewed, approved, and
implemented without undue delay to eliminate the causes of nonconformities. They are also
responsible for ensuring the effectiveness of actions taken.
5.3 The Initiator is responsible for conducting follow-up activities to verify the completeness and
the effectiveness of the actions taken.
5.4 The QMR may initiate requests for actions upon identification of NC or OFI.
5.5 IQA Auditors are authorized to initiate RFA through their Audit Team Leader.
5.6 The IQA Team Leader maintains a registry of issued RFA.

6.0 PROCEDURE DETAILS

6.1 Identification of Nonconformities

Nonconformities are identified through or during conduct or as a result of the following:

6.1.1 Operations;
6.1.2 Benchmarking;
6.1.3 Analysis of similar processes;
6.1.4 Evaluation of previous outputs/activities relative to the operations;
6.1.5 QMS audits;
6.1.6 Customer feedback; and,
6.1.7 Supplier evaluation.

6.2 Documenting and Reporting of Nonconformities

Identified nonconformities should be recorded on the RFA Form.

6.2.1 Prior to issuance of RFA, the form is assigned a serial number as follows:

AAA-XX-YY

Sequence number
Year
Origin
CDDSSS - SSSD department

Nature of Revision: Document Distribution:


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Corrective and Preventive Action
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CNU-QP-04 Quality Procedure Effectivity:

6.2.2 RFA form contains information that includes, but not limited to:

 Description of potential or actual nonconformity/nonconformance/OFI;


 Root-cause analysis, if applicable;
 Proposed action;
 Individuals responsible for initiating and implementing action;
 Target completion date; and,
 Follow-up action date.

6.3 Corrective and/or Preventive Action Implementation

6.3.1 The individual or unit/group responsible for the identified nonconformity identifies its
root cause and implement appropriate action in a timely manner. The identified root
cause is recorded in the appropriate section of the RFA.
6.3.2 For actions to be effective, they should be focused on addressing the root-cause rather
than the detected NC/OFI.
6.3.3 The reviews and approves the actions indicated in the RFA, prior to their
implementation.

6.4 Verification of Actions Taken

6.4.1 Details of the actions taken and the verification results are written on the follow-up
portion of the RFA.
6.4.2 Once the target completion date is due, the IQA Team Leader/Initiator verifies the
action taken and records this in the RFA.
6.4.3 If verification necessitates additional action plan or follow-up, the next follow-up date
is agreed upon.
6.4.4 To ensure that needed actions are prevented from unnecessary delays, follow-ups
shall be limited to only three times wherein the CNU Head conducts the third and final
follow-up.

6.5 Effectiveness of Actions Taken

6.5.1 Effectiveness of actions taken is discussed and verified during --- meetings wherein
information relevant to RFAs is considered.
6.5.2 Records of review on effectiveness of actions taken are maintained per department.
6.5.3 Status of actions taken is included in the agenda and is discussed during management
reviews.

7.0 REFERENCES:

7.1 CNU-QP-04 F01 - Request for Action Form


7.2 CNU-QP-03 - Control of Nonconformity
7.3 CNU-QP-05 - Internal Quality Audit

Nature of Revision: Document Distribution:


Page No.: Page 1 of 4
Internal Quality Audit
Revision No.: 0
CNU-QP-05 Quality Procedure Effectivity:

1.0 PURPOSE:

1.1 To establish, document, and maintain a procedure for the CNU’s Internal Quality
Audit (IQA).
1.2 To define the system for the planning, preparation, execution, follow-up, and
reporting of IQA activities in determining whether:
1.2.1 The QMS conforms to the planned arrangements, to the requirements of ISO
9001, and to the established quality management system; and,
1.2.2 The QMS is effectively implemented and maintained.

2.0 SCOPE:

2.1 This procedure applies to the CNU’s quality management system whose processes
directly affect the quality of services delivered to the customer.

3.0 DEFINITION OF TERMS:

3.1 Audit - Systematic, independent, and documented process for


obtaining evidence and evaluating it objectively, to
determine the extent to which criteria are fulfilled.
3.2 Audit Criteria - Set of policies, procedures, or requirements, used as
reference against which audit evidence is compared
3.3 Audit Evidence - Records, statements of facts or other information, which
are verifiable and relevant to the audit criteria. It can be
qualitative or quantitative
3.4 Audit Findings - Results of the evaluation of the collected audit evidence
against audit criteria
3.5 NC - Nonconformity, Non-fulfillment of requirement
3.6 Disposition - Actions to be taken to address nonconformities
3.7 Control Measures - Measures to be taken to prevent occurrence of an
identified
3.8 RFA - Request for Action form
3.9 OFI - Opportunity for Improvement; Statement of fact or
condition that does not signify a failure in the system but
may be enhanced
3.10 QAO - Quality Assurance Officer

4.0 PROCEDURE DETAILS:

4.1 Responsibilities

4.1.1 The QAO is responsible for ensuring that a complete audit on the quality
management system takes place at least once a year.
4.1.2 The IQA Team Leader is responsible for ensuring the proper implementation
of this procedure.
4.1.3 The process owners are responsible for ensuring that appropriate actions,
with regard to audit findings are taken without undue delay to eliminate their
causes.
Nature of Revision: Document Distribution:
Page No.: Page 2 of 4
Internal Quality Audit
Revision No.: 0
CNU-QP-05 Quality Procedure Effectivity:

4.1.4 The auditor(s) who carried out the audit, which resulted in raising audit
findings, is responsible for conducting follow-up activities to verify the
completeness and the effectiveness of the actions taken.
4.1.5 Auditor(s) are responsible for preparing the necessary tools and Audit
Checklist to be used for the Audit.

4.2 Planning the Audit

4.2.1 An Annual Audit Plan is prepared by the IQA Team Leader before the start
of a calendar year.
4.2.2 The Annual Audit Plan contains the schedule for a twelve-month period
during which the whole of the quality management system will be audited,
at least once.
4.2.3 In addition to the planned audits, unplanned internal audits may be initiated
by the QAO, if deemed necessary. Decisions for initiating unplanned
internal audits should be based on:
 unusual increase of quality related problems,
 introduction of new products and services,
 changes on the quality system, personnel and processes, and,
 customer’s request.

4.2.4 The Annual Audit Plan is reviewed and approved by the President prior to its
implementation.
4.2.5 Copies of the Annual Audit Plan are disseminated to all concerned
departments through a memorandum prepared by the QAO.
4.2.6 Prior to conducting an audit, both planned and unplanned audit require a
notification, to be given at least a week before the conduct of audit, to
affected functions. Notification of an audit shall be in the form of an Audit
Schedule prepared by the IQA Team Leader.
4.2.7 An Audit Schedule shall include the:
 purpose of the activity;
 audit scope;
 departments to be audited with their designated representatives;
 assigned auditors; and,
 date and time of the audit.

4.2.8 Auditors, who are tasked to conduct the audit shall be selected from the pool
of qualified personnel listed on the Memorandum Order duly signed by the
President. Auditors registered on the list are trained and qualified in
accordance with appropriate education, training, skill, and experience, as
suggested in ISO 19011:2002.

4.3 Preparation for the Audit

4.3.1 Upon notifying auditors and auditees, necessary documentation (e.g.


Quality Manual, Manual of Operations, QMS records) are reviewed by
auditors.

Nature of Revision: Document Distribution:


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CNU-QP-05 Quality Procedure Effectivity:

4.3.2 Taking into account the audit scope, objectives, and the information gained
from the review of various documents and records, Audit Checklists are
developed.
4.3.3 The checklist is used flexibly. It is not used as a questionnaire which, when
completed, signals the end of the interview. During the audit, the auditor
may add to the checklist, depart from it, and return later, or may decide not
to cover some items.

4.4 Conducting the Audit

4.4.1 An opening meeting is conducted prior to actual audit to reconfirm audit


schedule, basis for the audit, and audit participants. The meeting is usually
an informal one with no record being kept except those necessary for the
smooth conduct of the audit.
4.4.2 An Audit proper must have the following activities:

 Establishment of facts by interviewing personnel, reviewing


documents, observing processes, and verifying records.
 Recording of facts as evidence of the audit.
 Evaluation of facts to determine the objective evidence of a
nonconformity.
 Classifying audit findings as to NC or OFI.

4.4.3 Closing meeting is conducted to present audit findings to the


Deans/Directors/Heads of Offices of the audited area. RFAs are issued to the
Deans/Directors/Heads of Offices after the closing meeting.

4.5 Reporting of Audit Findings

4.5.1 Audit findings, are documented on the Request for Action (RFA) form.
4.5.2 Audit follow-up is conducted on or after the target implementation/completion
date, to verify whether the appropriate action is effectively implemented.
4.5.3 Details of the actions taken and the verification results are written on the
follow-up portion of the RFA.
4.5.4 In case of a rescheduled follow-up, the auditor ensures that the new follow-
up date is properly recorded in the RFA.
4.5.5 “Closed” RFAs are returned to the IQA Team Leader.
4.5.6 An Audit Summary Report is prepared by the IQA Team Leader and
submitted to the QAO for approval.
4.5.7 To provide evidence of a systematic audit and for useful references, the IQA
Team Leader maintains all relevant records of concluded internal audits.
4.5.8 Results of internal audits are discussed and presented during management
review meetings.

4.6 Verification of Actions Taken

4.6.1 RFAs are forwarded to the IQA Team Leader, who assigns control numbers
for monitoring purposes. The IQA Team Leader maintains a registry of all
RFAs.
Nature of Revision: Document Distribution:
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CNU-QP-05 Quality Procedure Effectivity:

4.6.2 Corrective/preventive actions are implemented without undue delay.


Guidelines are given on Corrective and Preventive Action Procedure.
4.6.3 Actions to address OFIs are recommended but not required.

5.0 REFERENCES:

5.1 CNU-QP-04 - Corrective and Preventive Action Procedure


5.2 CNU-QP-04 F1 - RFA form
5.3 CNU-QP-05 F1 - Audit Checklist

Nature of Revision: Document Distribution:


forms
MASTERLIST OF DOCUMENTED Issue No.:

INFORMATION _____________

Documented Information Retention Originator /


Document No.
Title Period Process Owner
CNU-01

Prepared by: Noted by:

Document Controller / Date QMR / Date

CNU-QP-01 F01 Rev. 0


Issue No.:
EXTERNAL DOCUMENT DISTRIBUTION LIST
____________

Reception Distribution
Document Type From
Received Signature / Recipient / Signature /
by date Addressee date

Prepared by: Noted by:

Document Controller / Date QMR / Date

CNU-QP-01 F01 Rev. 0


Issue No.:
DOCUMENT DISTRIBUTION LIST ___________

Document:
CNU-QP-01FO3 Control of Documents
Page Revision Effectivity Issued to / Custodian Group/Division/Unit Signature/date
No. No.

Prepared by: Noted by:

Document Controller / Date QMR / Date

CNU-QP-01 F01 Rev. 0


DOCUMENT FEEDBACK FORM
Initiated by: Document No., Title: Date:

Purpose/Reason for Document Revision or Creation:

Suggested / Proposed Revision:

This part must be filled-up by the Document Controller in coordination with concerned
Process Owner and Approving Authorities
Received Feedback/Actions taken/Disposition: Noted by/date:
by:

CNU-QP-01 F04, Rev. 0

---------------------------------------------------------------------------------------------------------------------------

DOCUMENT FEEDBACK FORM


Initiated by: Document No., Title: Date:

Purpose/Reason for Document Revision or Creation:

Suggested / Proposed Revision:

This part must be filled-up by the Document Controller in coordination with concerned
Process Owner and Approving Authorities
Received Feedback/Actions taken/Disposition: Noted by/date:
by:

CNU-QP-01 F04, Rev. 0


RFA No.:

REQUEST FOR ACTION


CNU-QP-04 FO1

DESCRIPTION Nonconformity OFI

DETAILS

Action request as a result of:

Internal Quality Audit Service Realization Process Others:

REFERENCES (manuals, procedures, policies, , etc.)

Area / Division / Office:

Initiato Signature over Issued Signature over Issued Signature over


r printed name / date by: printed name / date to: printed name / date

Definition:
NC - Nonconformity. Deviation from a specified requirement that need immediate action.
OFI - Opportunity for Improvement. A lapse in the system that causes minor errors or may cause potential problems and therefore may need to be improved

Note: The agency head or his/her delegate conducts the final follow-up on unaccomplished corrective/preventive action.
RFA No.:

REQUEST FOR ACTION


CNU-QP-04 FO1

Position, Division Position, Division Position, Division


ANALYSIS (Root Cause)

DISPOSITION / ACTION

Correction Target date:__________ Corrective /Preventive Action (must address root cause):
Target date:__________

Prepared Signature over printed name / date Signature over printed name / date
Approved by:
by: Position, Division Position, Division

FOLLOW-UP ON ESTABLISHED ACTION (refer to DISPOSITION / ACTION)

Auditee / Person
Auditor / who prepared the
Date Result / Additional Action Plan (if unresolved) Remarks
Initiator disposition / action
plan
Initial/
First

Second

Final

CNU -QP-04 F01, Rev. 0


Definition:
NC - Nonconformity. Deviation from a specified requirement that need immediate action.
OFI - Opportunity for Improvement. A lapse in the system that causes minor errors or may cause potential problems and therefore may need to be improved

Note: The agency head or his/her delegate conducts the final follow-up on unaccomplished corrective/preventive action.
IQA No.:

AUDIT CHECKLIST

Auditee/s Division/Section/Group Page

of
Audit Type Date of Audit Time Auditor/s
[ ] [ ] [ ] Start End
IQA Follow-up Supplier

AUDIT CRITERIA AUDIT NOTES/REMARKS


(Define the requirement that must be satisfied i.e. customer requirements, DESCRIPTION (Describe your observations on the extent of conformance with the specified
regulatory requirements, process requirements, ISO 9001 requirements,
requirements)
etc.)

CNU-QP-05 F1, Rev. 0

* DESCRIPTION
Conformity, Requirement has been met; No action required Not Applicable , No action
C NA required
Nonconformity Opportunity for Improvement
N Failure to meet one requirement of a clause of ISO Statement of fact or condition that does
9001:2000 or set criteria; a lapse in the system
OFI not signify a failure in the system but need
C
that needs improvement. to be addressed
Issue No.:
REVISION HISTORY _____________

Document No. Title:

Effectivity
Revision Page Approval
Description of Changes Date
No. No.
Name Signature

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