Quality Procedure Title:

DOCUMENT CONTROL
Rev: Date Approved: Date Received By DCC: Doc. No. : Page:

5 April 06, 2011 Revised By: V.M. Comia, RMT

QMR

Reviewed by: A.A. Comia ; V.C. Espina

FM MM

QP-001 1 of 13 Approved by: C.G. Espina, RMT

GM

DOCUMENT APPROVAL & DISTRIBUTION SHEET FOR CIRCULATION FOR DISTRIBUTION Distribution List (as per applicability) General Manager Marketing Manager Finance Manager QMS Manager Human Resources Accounting Unit Laboratory Unit Medical Unit Radiology Unit Industrial Clinic Medical Director Data Controller Operations Officer REVISION HISTORY QP-001: Revision Control Rev. 0 1 2 3 Reference
PCAHO Standard PCLI-QP-001 Rev. 0 PCLI-QP-001 Rev. 1 PCLI-QP-009 Rev. 2

Signature & Date Received New/Revised Document Signature Date

Signature & Date Returned Old Document Signature Date

Date 2001/02/13 2003/05/15 2006/06/02 2009/09/22

Page No. N/A 1-11 1-13 1-13

Description of Change No Change First Issue Total Revision of Service Delivery Total Revision to address revised PCAHO Standard; Changed Document Number to PCLI-QP-009 Total Revision to address requirements of ISO 9001:2008; Changed Document Number to QP-001 Minor Revisions: Section 4 will be the Procedures; Section 5 will be the References/Associated Documents; Section 6 will be the Resources Needed and Section 7 will become Records Retention Table. Removed attachments. Added procedure for Automated DCC. Major Revision in processes (more elaborated & detailed step by step procedure). Added procedure for Document Control Re-Verification, faxed documents & memorandum circular.

QP-001 Rev.3

2011/02/16

All

QP-001 Rev. 4

2011/04/05

All

DO NOT IMPLEMENT IF WITHOUT RED CONTROLLED DOCUMENT STAMP FROM DCC:

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TABLE OF CONTENTS

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1. 2. 3. 4.

PURPOSE ............................................................................................................................................................. 3 SCOPE ................................................................................................................................................................... 3 TERMS AND DEFINITIONS .............................................................................................................................. 3 PROCEDURE ....................................................................................................................................................... 4 4.1 4.2 4.3 4.4 4.5 4.6 4.7 Document (Procedures) Creation/Revision.................................................................................... 4 External Documents ............................................................................................................................... 7 Obsolete Documents ............................................................................................................................... 8 Procedure on Requesting for Document Copy ................................................................................ 8 Procedure for Guidelines Creation/Revision/Removal ............................................................... 9 Automated Document Control System ............................................................................................10 Document Control Re-verification Procedures .............................................................................10

See G-QMS-10 ...................................................................................................................................................10 4.8 4.9 5. 6. 7. Procedure for Faxed Documents.......................................................................................................11 Procedure for Memorandum Circular .............................................................................................11

REFERENCES/ASSOCIATED DOCUMENTS ................................................................................................12 RESOURCES NEEDED ......................................................................................................................................12 RECORDS RETENTION TABLE......................................................................................................................12

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1. PURPOSE The purpose of this procedure is to provide a consistent method for the control of documents, both internal and external in nature, hard copy or electronically available, which are utilized in the operations and processes of PCLMCI. This shall also provide the process for the creation, revision and approval of new or existing document as well as its distribution or circulation, storage, retrieval, archiving and disposal. 2. SCOPE This Quality Procedure applies to all important information sources, documents and data of PCLMCI which may be internal or external in origin, hard copy or electronically available, utilized in its operations and processes. This defines the controls needed for the creation, review, approval, necessary updating, revision, distribution, circulation, storage, retrieval, archiving and disposal of the above-mentioned types of documents and information sources. 3. TERMS AND DEFINITIONS TERM DEFINITION Controlled - A document that is subject to change control during its life cycle. Examples Document are procedures; specifications; reports; wherein they can be revised and reissued. It also means that the document may have been checked or reviewed prior to its release. Customer - Organization or person that receives a service or services from PCLMCI. External Document - A document that originated from external parties (i.e. Government Rules/Standards, Manuals, etc.) For Circulation - A type of document which is circulated ONLY among specified recipients of the information contained in that document For Distribution - Copies of the original document can be distributed equally among specified recipients Internal Document - A document that is prepared, revised and/or established by individuals within PCLMCIs organization Major Revisions - Those revisions or changes which affect the content of quality of the action being prescribed in the document, such as updated technology resulting in change of procedure or multiple changes within the document. Minor Revisions - Those revisions or changes that do not affect the content of quality of the action being prescribed in the document, such as typographical or grammatical changes, template formatting or small changes within the document Obsolete Document - Old, discarded, no longer used, superseded and/or revised document Quality Manual - Defines the scope of the QMS and documents the Quality Policy, referenced Quality Procedures, Standard Operating Procedures and processes that have been implemented to achieve the companys Quality Objectives. Reference Only - Old documents kept as reference, usually revised or superseded. Retention - The act or an instance of retaining Revision - As applied herein, it pertains to a change or changes made to an already established document, duly reviewed and approved for use. Uncontrolled - A document that is not subject to change or revision. It is usually issued once Document and may be re-copied without formal authorization. ACRONYMS ADCS -Automated Document Control System DC -Document Controller DCC -Document Control Center DCR -Document Creation/Revision/Removal Request DCRRN -Document Creation/Revision/Removal Notice PCLMCI -Pioneer Clinical Laboratory & Medical Clinic Inc. QMR -Quality Management Representative QMS -Quality Management System QP -Quality Procedure SOP -Standard Operating Procedure WI -Work Instructions

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4. PROCEDURE The following table depicts processes described in this document, as well as the responsibilities and actions that shall be performed by process participants. 4.1 Document (Procedures) Creation/Revision Person Process Flow Reference/Notes Responsible a) Determine End-User of Done as result of: need to Document/ Document Review done prior to Management Review (bicreate/revise Unit Heads/ annually as per QP-004; or as the need arise) document Officers/ Modifications in existing procedure Managers Newly imposed procedure by statutory or regulatory authorities b) Accomplish Author/ Use DCR Form (QF-01) DCR form Requestor Write the affected documents as well as the summary recommendation/revision details. Indicate in the Type of Action Requested portion, if it is either: Major Revision = part or parts of the procedure has to be modified; additional process has to be implemented; part or parts of the procedure is/are no longer practiced (removed/deleted) Minor Revision = correction of typographical errors only For newly created procedures, write Creation. Ensure DCR form is properly accomplished up to Action To Be Taken portion (check appropriate box). c) Approve/ Immediate See Table 1 for Document Approval Matrix. Disapprove Superior IF DCR is not approved: action to be (Supervisor/ indicate reason for non-approval, taken Officer/Manager) - signature & valid reason of immediate superior is required -forward DCR to DCC notify author/requestor - use DCR (Notification Confirmation portion) file DCR - register in DCR Log Sheet (QF-33); - stamp with NOT APPROVED, in blue ink and file as Internal Record. d) *Assign a DC *For Newly Established Documents: Document Level 1: PCLI-QM-01 where QM-Quality Manual; 01 series Number number starting 01 Level 2: QP-001 where QP-Quality Procedure; 001 series number starting 001 Level 3: SOP-01 where SOP-Standard Operating Procedure; 01 series number starting 01; and WI-XX-Y where WI-Work Instruction; XX corresponding SOP(2-digit) or QP(3-digit) series number; Y series number starting 1. Level 4: Forms Refer to QP-002, Control of Records procedure. For documents under revision, retain the Document No. For documents subject for removal from the DCC, use the assigned document number (re-use) for newly established procedures. e) Create / Revise Author/ Use QF_20, Official Document Template Document Requestor/ Standard Font: Cambria; Size: 10 Technical Person/ Standard Paper Size: A4 (8.27 x 11.69) QMRs Margins : Recommended Top (1); Left (1.2); Bottom (1); Right (0.8) Person Footer from Bottom: 0.3; Header from Top: 0.5

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Format: 1. Purpose 2. Scope 3. Tems & Definitions 4. Procedure 5. References/ Associated Documents 6. Resouces Needed 7. Records Retention Table For document revision, ask DC for the soft copy (master copy; latest revision) as well as a photocopy of the original document to be revised. DC should stamp the duplicate copy as UNCONTROLLED DOCUMENT in blue ink upon issuance. This uncontrolled copy shall serve as the attachment (supporting documentation) to the DCR, showing the revisions made on the document.
NOTE 1: The requestor need not be the same person who established (author) or will make the revisions to the procedure for DCR. Revisions can be made by anyone who have technical expertise regarding the procedure or as per QMRs recommendation.

f) Submit document & approved DCR for document review g) Review Document

Author/ Requestor/ Technical Person/ QMRs Recommended Person Reviewer

See Table 1 for Document Approval Matrix. Include any supporting documentation.

h) Approve Document i) Submit softcopy to DCC

General Manager Author/ Requestor/ Technical Person/ QMRs Recommended Person

See Table 1 for Document Approval Matrix. Evaluate the document for technical accuracy, conflict with other Unit or Section policies or procedures, if known, training needs, additional resources, and any impact to customers. Seek input from clients, staff and other departments if appropriate. Ensure if document contains all elements. Use reference documents and other pertinent information upon which to base approval. IF document is not approved: Changes are noted; document is sent back to Author/Requestor Technical Person/ QMRs Recommended Person for needed modifications A new DCR shall be accomplished by Requestor & DC shall note the new DCR No. in the Refer to DCR No. portion. Revised document (w/ noted changes incorporated/completed) should be returned to the Reviewer on the date specified in the Return To: _________ on __________ portion. After revision/changes are made, document is subject for another Document Review. See Table 1. Document Approval Matrix DCC acceptance criteria: Completely accomplished & approved DCR Approved by GM Complete attachments & stamps DC and/or QMR are the only authorized personnel to save & print the master copy of the submitted document. Refer to 4.6, Automated Document Control System

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Process Flow j) Register Document Person Responsible DC

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k) Accomplish Distribution Sheet & Revision History page

DC/QMR

l) Accomplish DCRRN

DC

m) Stamp Document n) Distribute new/revised document & retrieve old documents

DC

DC

o) File Document

DC / Unit or Department Head (P.I.C.)

Register in PCLMCIs Document Control Center as controlled document. Copies are made available to employees for use during execution of their job, both in hard and soft copies (see par. 4.6, Automated Document Control System) Update form QF-21A, Internal Documents Masterlist. Fill-out the Document Approval & Distribution Sheet. Indicate the persons and/or Units to whom/to which the procedure shall be ditributed or circulated. Specify the details of the revision(s) made in the Revision History portion. For new procedures, just indicate No changes, first issue. Each release will be dated with the issue date of the document or change indicating the effective date of the document. Use QF-02, Document Creation/Revision/Removal Notice Always indicate the DCR which it corresponds to in the For DCR No.:_______ portion. Specify the no. of controlled copies and/or uncontrolled copies (if necessary) for distribution as well as the filing intructions (remove/insert; page(s) to be removed/ inserted). Write down the Orientation/Education or Training Requirements: Date & Attendees Check the Not Applicable box if orientation/training is no longer needed. Show revision update; detail the description of change(s) done to the document (for [latest] revised documents only; not applicable for newly created documents). Have concerned personnel sign the Conforme portion. Original Copy -stamped ORIGINAL COPY & CONTROLLED DOCUMENT in red ink; duplicate copies (for distribution) stamped CONTROLLED DOCUMENT only. Signatures (in blue ink) shall be obtained from all the representatives listed in the Distribution List. Original copies of revised/obsolete documents retrieved are stamped REVISED in red ink & OBSOLETE in red ink. Thsese copies are retained in the Archive as per Records Retention Schedule (see QP-002, Control of Records). Revised/Obsolete documents which are still needed as reference are retained in the area & stamped REVISED, OBSOLETE in red ink and REFERRENCE ONLY in blue ink. Have recipient sign in the Received By portion of the Documents for Distribution Logbook. Department / Unit Color Coding (Upper Band): General Manager: Navy Blue Marketing: Royal Blue QMS: Aqua Marine Finance: Yellow Operations: Red Laboratory: Pink Radiology: Orange Medical: Green Industrial Clinic: Purple Binder/Folder Color Coding (Lower Band): Level 1: Quality Manual: Royal Blue Level 2: Quality Procedures: Royal Blue Level 3: SOP- Maroon; WI- Olive Green; Guidelines- Yellow Level 4: Forms Red; Memo- Lilac; External Docs.: Yellow Green
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q) Give orientation

Author/ Requestor/ Technical Person/ QMRs Recommended Person

r) Implement new/ revised procedure

Person Responsible

Register in DCR Log Sheet (QF-33); DCR-XY-ZZ where DCR, Document Change Request; XY, last two digits of the year; ZZ, series number from 01. For the following year, DCR No. starts back at -01. Refer to DCRRN for the date & attendees. Provide attendance sheet and submit to HR for filing. Refer to QP-005, Competence, Awareness & Training Update QF-17, Employee Orientation Log Sheet. Done as General Assembly or attended by QC members [only] for Level 1 & Level 2 documents and/or Guidelines. Unit & Department Heads shall orient/re-orient their respective subordinates for newly created/revised [process-specific] SOPs & WIs (Level 3 documents). Revised document must be implemented the day following the orientation. Do not implement if without RED CONTROLLED DOCUMENT stamp from DCC. Review procedure on a regular basis to monitor its effectiveness.

4.2 External Documents Person Process Flow Reference/Notes Responsible a) *Submit PCLMCI Employee Books, Manuals, Training Materials, Memos, Machine Operator Original Copy manuals, MSDS, permits, certificates, statutory and/or regulatory to DC documentation, etc.
*NOTE 2: For faxed documents, see par. 4.8 Procedure for Faxed Documents

b) Register & Issue Control No.

DC

c) Stamp Document d) Provide Label Sticker of control no.

DC DC

e) Provide EndUser copy

DC

Register received document in the DCC Receiving Logbook: Date Received Received From Document Title Classification No. of Copies Issue control number: EX_Document Code_001: where EX = External; Document Code (as per type of document) = BK (Book)/ CN (Compilation/Training Module)/ ML (Manual); 001 = series no. starting 001. Stamp as EXTERNAL DOCUMENT in blue ink (all pages); for books, stamp the first & last pages only. Place it on the upper right corner (first page only); for books, including the cover (side). Label Sticker should contain the following: Control Number Issued To: Type of Copy: (either original or distributed copy) Copy XX of YY; where XX = copy number issued to user; YY = total no. of copies received/distributed. Retain the original copy in the DCC; stamp with ORIGINAL COPY in red ink. Stamp distributed copies as REFERRENCE ONLY in blue ink. Not applicable for books, operator manuals & other published work (no need to photocopy, original copy shall be issued). Have recipient sign in the Received By portion of the Documents for Distribution Logbook.

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Indicate in QF-21B, External Documents Masterlist: 1Doc. Code No.; 2Title of the External Document; 3Edition; 4Author; 5Classification (Book/Manual/Compilation); 6Subject/Field; 7Location (Current); 8No. of copies, including distributed copies; 9Issued To; 10Date Issued and 11Disposition (In Use/ In DCC/ Discarded).

4.3 Obsolete Documents Person Process Flow Responsible a) Identify End-User of obsolete Document/ documents Unit Heads/ Officers/ Managers

Reference/Notes Obsolete documents (soft or hard copy) may be one of/related to the following (internal or external in origin): 1. Revised/superseded documents/procedures 2. Outdated masterlists 3. Outdated bulletin posts 4. Expired permits, certificates and other statutory and/or regulatory documentation 5. Obsolete Operation and Maintenance manuals (Machines) 6. Outdated/Revised Maps, Flowcharts, Charts 7. Outdated Report, Checklists & Schedule/Calendar of Activities 8. Obsolete Forms 9. Outdated Registers/Log Sheets 10. Inactive forms/procedures for 2 years Use DCR Form (QF-01) Write the affected documents as well as the summary recommendation/revision details. Indicate in the Type of Action Requested portion: Removal (Obsolete) Ensure DCR form is properly accomplished up to Action To Be Taken portion (check appropriate box).
*NOTE 3: Accomplishment of DCR form is applicable only for items no. 1, 8 & 10 of par. 4.3a.

b) *Accomplish DCR form

Author/ Requestor

c) Approve/ Disapprove action to be taken d) Retrieve & Stamp Obsolete Documents

Immediate Superior (Supervisor/ Officer/Manager) DC

Refer to par. 4.1 c

e) Update Document Masterlists

DC

Register retrieved obsolete document in QF-47, Obsolete Documents Master List. Original Copies: For NON-PROCEDURES, stamp OBSOLETE in red ink & retain in the Archive Room as quality record (refer to par. 7, Records Retention Table). For OBSOLETE PROCEDURES, refer to 4.1 n. Distributed Copies: Collect for Shredding. Soft Copies: Save in CD or external hard drive (archived docs.) Refer to QP-002, Control of Records procedure. QF-21A, Internal Documents Masterlist QF-21B, External Documents Masterlist

4.4 Procedure on Requesting for Document Copy Person Process Flow Reference/Notes Responsible a) Accomplish Requestor Utilize form QF-01A, Copy Request Form Copy Request Accomplish up to Purpose portion & submit to DC Form b) Approve/ DC Copy request is valid, ONLY for the ff purpose(s): Disapprove Controlled Copy: Requestor is not included in Distribution List

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c) Issue copy of requested document

DC

d) File Copy Request form for reference

DC

but should have a copy (compulsary) Uncontrolled Copy: Requestor needs it as attachment in DCR (Document Revision). Reference Only: (Uncontrolled Copy); Requestor needs to have a copy for reference. If NOT APPROVED, indicate reason for non-approval. For copies of Controlled Documents, see 4.1 m. For copies of Uncontrolled Documents, see 4.1 e. For copies to be used as reference, stamp document with REFERENCE ONLY and UNCONTROLLED DOCUMENT in blue ink upon issuance. Copy request form should be signed as Noted By by the QMR, and signed as Received By by the requestor. Also, have recipient sign in the Received By portion of the Documents for Distribution Logbook. See par. 7, Records Retention Table Refer to QP-002, Control of Records

4.5 Procedure for Guidelines Creation/Revision/Removal Person Process Flow Reference/Notes Responsible a) Accomplish Author/ Refer to 4.1b (Creation/Revision) DCR Requestor Refer to 4.3b (Removal) b) Approve/ Immediate Refer to 4.1 c Disapprove Superior action to be (Supervisor/ taken Officer/Manager) c) *Assign a DC Format: G-XXX-YY-ZZ, where G, Guideline; XXX- Unit Code; YYGuideline Series Number starting 01; ZZ copy number starting 00 (where Number 00 would be the DCC copy). Unit Codes:
FIN = Finance Dept. HRU = Human Resources Unit INC = Industrial Clinic LAB = Laboratory Unit MAR = Marketing MED = Medical Unit OPN = Operations Department QMS = Quality Management System Dept. RAD = Radiology Unit

d) Create/ Revise Guideline e) Review Guideline f) Approve Guideline g) Submit softcopy to DCC h) Register Document i) Update ADCS

Author/ Requestor Immediate Superior / QMR GM Author/ Requestor DC DC/QMR

Use the Guideline Template (QF-31) Refer to 4.1 g See Table 1 Document Approval Matrix Refer to 4.1i Refer to 4.1j Update form QF-21A, Internal Documents Masterlist. Specify the details of the revision(s) made in the Revision History portion. For new procedures, just indicate No changes, first issue. Refer to 4.1l Refer to 4.1m

j) Accomplish DCRRN k) Stamp Guideline

DC DC

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Process Flow l) Distribute guideline Person Responsible DC

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Required signatures (Preparation, Review & Approval) should be in blue ink for the DCC Copy (-00 copy); while distributed copies are marked w/ ORIGINAL SIGNED only. Refer to 4.1n Retrieve old/superseded guideline, if applicable, (see 4.4d) Have recipient sign in the Received By portion of the Documents for Distribution Logbook. Refer to 4.1o Refer to 4.1p Refer to 4.1q Refer to 4.1r

m) File Document

n) File and Register DCR o) Give orientation p) Implement new/ revised guideline

DC / Unit or Department Head (P.I.C.) DC Author/ Requestor/ Person Responsible

4.6 Automated Document Control System Person Process Flow Reference/Notes Responsible a) Submit softcopy Author/ Refer to 4.1i to DCC Requestor b) Convert DC/QMR This is to ensure that documents are controlled by soft copy. For viewing and/or review, only the files in PDF format are available on softcopy to PDF server. format c) Save document DC/QMR Only the latest version of the documents shall be available on server. in specific Retrieve the superseded/obsolete files and save in CD (properly labeled) or external hard drive (archived docs.) destination Refer to QP-002, Control of Records procedure. folder d) Upload/Register DC/QMR Log on to http://dc/dc/mainmenu.php (removed hyperlink) Only the DC & QMR have super-user or administrator access to documents in the ADCS as control measure. the ADCS (Super User) e) Provide inforDC/QMR Employees are informed thru all of the following: Memo mation about E-mail uploaded Verbal information documents f) Log-in in the Employee Log on to http://dc/dc/members.php (click link to view) program Each Department & Unit Head are given usernames and passwords in order to view the files online. (Members Area) g) Click Files Tab Employee From the drop-down menu, select Documents. h) Select prefered Employee A new window will appear w/ drop-down menu w/c is divided into 3 seach keys (refinement options), as to: search key Description (Title of Document) Code (Document Code) Author Type either the title, document code or author in the space provided then press Enter( ) or click Search button. The program will automatically take you to the documents link. i) View Document Employee Either double-click on the documents link or press View button to view the desired document (opens in a new window). j) Exit program Employee Close all open windows (click Close button) & from the Files tabs drop-down menu, click Exit Program. 4.7 Document Control Re-verification Procedures See G-QMS-10
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4.8 Procedure for Faxed Documents Person Process Flow Reference/Notes Responsible a) Receive Fax Employee / DC If the sender is still on the line, ask for his/her name & note it in the faxed document as Received From; if otherwise, proceed to 4.8b. b)Stamp Fax Employee / DC Stamp as EXTERNAL DOCUMENT or EXTERNAL RECORD in blue ink (all pages) Either stamp Received by and put initials & date received -ORwrite down, Received By: [Initials] & date received. c) Photocopy Fax Employee / DC 1 copy only d)Give fax to Employee / DC Either ask intended recipient to pick it up or bring it personally to intended recipient him/her. Photocopy is provided to intended recipient. e) File original copy Employee / DC Place in the Faxed Documents Binder See par. 7, Records Retention Table for the retention schedule. 4.9 Procedure for Memorandum Circular Person Process Flow Reference/Notes Responsible a) Ask DC for Memo Manager/Officer/ DC controls the memo. numbers (to ensure that memos created Number Supervisor are in chronological order). Format: ZZZZ-YYY; where ZZZZ = current year and YYY = series no. starting -001. For the following year, the numbering starts back at -001. b)Create Memo Manager/Officer/ Use form QF-35, Memorandum Circular Template Supervisor Indicate the following: Memorandum No. To (Recipient(s) of the memo) From (Sender/Creator of memo) Date (Date the memo is created) Re (in reference to/topic of memo) Send soft copy to Reviewer. c) Review Memo Reviewer Refer to Table 1, Document Approval Matrix d)Approve Memo GM e) Print & Sign Memo Manager/Officer/ Provide signature & date in the Prepared By; Reviewed By & Supervisor Approved By spaces respectively. Give to DC the memo after all signatures have been satisfied & advise her whether the memo is for distribution or for circulation. f) Register Memo DC Register in PCLMCIs Document Control Center as controlled document. Update form QF-48, Memoranda Master List. g) Photocopy memo Dc No. of copies depends on the no. of intended recipients h)Stamp original DC Original copy: Stamp ORIGINAL COPY & INTERNAL memo & its RECORD in red ink photocopies Photocopies: Stamp INTERNAL RECORD in red ink only. Stamp either FOR CIRCULATION or FOR DISTRIBUTION (black ink) depending on the instructions of the creator of the memo. i) Distribute/ DC Have recipient sign in the Received By portion of the Circulate Memo Documents for Distribution Logbook as well as in the Conforme portion of the original copy of the memo (use blue ink) j) File Original Copy DC Refer to 4.1o & par. 7, Records Retention Table.
NOTE 4: The procedure for forms and/or templates (for reports, plans, drawings, maps, charts, calendars, schedule, bulletin posts) creation/revision/removal can be found in QP-002, Control of Records procedure.

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Table 1. Document Approval Matrix Level Document Creation/Revision Review Approval 1 Quality Manual QMR FM & MM General Manager Quality Procedure Responsible QMR/ FM and/or MM/ 2 General Manager (QP) Person Immediate Superior Standard Operating Procedure (SOP); Responsible QMR/ FM and/or MM/ 3 General Manager Work Instructions Person Immediate Superior (WI), Guidelines (G) Forms/Templates; Responsible QMR/ FM and/or MM/ 4 General Manager Memoranda Person Immediate Superior NOTE 5: If the creation/revision/removal of a document is done by the QMR, the FM & MM shall be the document reviewers
while the GM still, shall be the one to approve the new/revised/removed document.

5. REFERENCES/ASSOCIATED DOCUMENTS Document Code: Document Title: EX_085_ML ISO 9001:2008 Quality Management System- Requirements PCLI-QM-01 Quality Management System Manual QF-01 Document Creation/Revision/Removal Request QF-01A Copy Request QF-02 Document Creation/Revision/Removal Notice QF-04 Attendance Sheet QF-17 Employee Orientation Log Sheet QF-20 Document Template QF-21A Internal Documents Master List QF-21B External Documents Master List QF-31 Guideline Template QF-33 DCR Log-Sheet QF-35 Memorandum Circular Template QF-47 Obsolete Documents Master List. QF-48 Memoranda Master List QP-002 Control of Records QP-004 Management Review QP-005 Competence, Awareness & Training QP-013 Internal Quality Audit QP-014 Control of Nonconforming Materials/Services QP-015 Corrective/Preventive Action 6. RESOURCES NEEDED 6.1 Bond paper 6.2 Pencils 6.3 Pens 7. RECORDS RETENTION TABLE Identification Attendance Sheets Copy Requests DCC Receiving Logbook DCR Log-Sheets Document Creation/Revision/Removal Notices Storage HR Filing Cabinet DCC Filing Cabinet DC Cabinet DCC Filing Cabinet DCC Filing Cabinet Retention Unit/Office Archive Calendar 3 years Year Calendar 1 year Year As long as 5 years applicable Calendar 5 years Year Calendar Year 3 years Disposition Shred Shred Discard Shred Shred Protection Locked inside cabinet Locked inside cabinet Locked inside cabinet Locked inside cabinet Locked inside cabinet

6.4 Personal Computer 6.5 Photocopier 6.6 Folders

6.7 Binders 6.8 Paper Clips 6.9 Paper Clamps

ISSUE DATE: April 06, 2011 REV.5_040511

QF-20

DISCLAIMER: This document contains proprietary information to PCLMCI and may not be used or disclosed to others, except with the written permission from PCLMCI. Master documents are available at PCLMCIs Document Control Center.

Quality Procedure Title:

Rev.:

Page:

QP-001: DOCUMENT CONTROL

Identification Document Creation/Revision/Removal Requests Documents for Distribution Logbook Electronic copies of documents Employee Orientation Log Sheets External Documents
(Used as references)

5
Disposition Shred Discard Discard/Delete

13 of 13 Protection Locked inside cabinet Locked inside cabinet CDs locked inside cabinet Locked inside cabinet Locked inside cabinet Locked inside cabinet Locked inside cabinet Locked inside cabinet Locked inside cabinet Locked inside cabinet Locked inside cabinet Locked inside cabinet Locked inside archive Locked inside archive Locked inside cabinet

Storage DCC Filing Cabinet DC Cabinet DCC Filing Cabinet (in CDs) Respective Binders of Documents DCC Filing Cabinet DCC Filing Cabinet DCC Filing Cabinet DCC Filing Cabinet DCC Filing Cabinet DCC Filing Cabinet DCC Filing Cabinet DCC Filing Cabinet Archive Archive DCC Filing Cabinet

Retention Unit/Office Archive Calendar Year As long as applicable 2 years As long as applicable As long as applicable Calendar Year Calendar Year As long as applicable Calendar Year Calendar Year Calendar Year Calendar Year N/A N/A As long as applicable 3 years 5 years 10 years

1 year 3 years 3 years 1 year 3 years 3 years 3 years 3 years 5 years 3 years 5 years 5 years

Shred Shred Shred Shred Shred Shred Shred Shred Shred Shred Shred Shred

External Documents Master Lists Faxed Documents

(Non-Statutory/Regulatory)

Faxed Documents
(Statutory/Regulatory)

Internal Documents Master Lists Memoranda Memoranda Master List Obsolete Documents Master List Obsolete Documents (Others) Obsolete Procedures QPs, SOPs, WIs, Guidelines & other related documents

(Original Copies) NOTE 6: The above Records Retention Table is for original copies kept in the DCC only. Refer to G-QMS-06 for a more comprehensive Records Retention Schedule of QMS-Related Records.

ISSUE DATE: April 06, 2011 REV.5_040511

QF-20

DISCLAIMER: This document contains proprietary information to PCLMCI and may not be used or disclosed to others, except with the written permission from PCLMCI. Master documents are available at PCLMCIs Document Control Center.