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Control of Quality Records

Document Title:
This document is confidential to the person and to INCOS Lab. Inc. It may not be copied or distributed by any other person, nor should information be used for other than the purposes intended.

Doc. No. PM-11-07

Rev. No. 0

Page 1 of 3

Section: 11 PROCEDURES MANUAL


1.0 OBJECTIVE : To ensure that quality records are properly labeled, handled and maintained. 2.0 SCOPE :

Effectivity: January 15 , 2012

It covers all the records that provide evidence of quality system performance, and compliance by every department to quality standard and other specified requirements. 3.0 DEFINITION OF TERMS : Records Disposable Record Live Record
-

Record Index Obsolete Document

a written or stored information which provides objective evidence of activities performed or results achieved. record that has reached its maximum limit of retention and no longer serves any purpose. record that is more or less permanent in nature due to historical relevance of recorded data or information. Examples of such records include personnel data and training records, calibration records, machinery and equipment breakdown, maintenance record, product drawings, etc. a method of providing unique identification to compiled data to facilitate traceability, easy retrieval and refilling. an outdated document. Responsible Department Heads Details 1. When data are recorded manually this should be: Written legibly in ballpen or in similar writing instrument. Pencil must never be used in recording or writing data / information. Signature of personnel is affixed and dated if applicable. Verification / review/ approval signatures when required are affixed and dated to ensure that data recorded are correct and authorized. Correction to recorded data / information shall be authorized and signed by responsible personnel. Refer to (Documentation Requirements). Whenever necessary compiled record bears any of the following : a) Heading or title of the compiled records b) Coverage which corresponds to the period of compiled data / information. Example : APPROVED SUPPLIERS LIST (ASL) (as of January XXXX) Reviewed by: Approved by: 2.

4.0 PROCESS FLOWCHART : Flow

Start

Department Heads / Assigned Encoder

Identification of Records

DDCC
2

Indexing of Records

Prepared by:

Document and Data Control Custodian

Management Representative

President

Control of Quality Records


Document Title:
This document is confidential to the person and to INCOS Lab. Inc. It may not be copied or distributed by any other person, nor should information be used for other than the purposes intended.

Doc. No. PM-11-07

Rev. No. 0

Page 2 of 3

Section: 11 PROCEDURES MANUAL


Flow
A

Effectivity: January 15 , 2012

Responsible

Details 3. When records are stored in filing cabinets or other storage facilities, location charts or similar system shall be drawn to facilitate easy retrieval and re-filing of records. Unique identification to facilitate indexing / locating files such as the following method shall be employed : a) Filing cabinet reference code. b) Location identifiers. c) Color-coding as appropriate. 4. Records must be stored in a manner that will maximize risk of loss, damage and deterioration. Plastic folders, plastic covers or similar strong materials shall be used to protect compiled records. Note: Live records are retained for as long as the recorded data and information are deemed relevant.

Department Heads / Assigned Personnel

Retrieval of Records

Storage of Records

Department Heads / Assigned Personnel

Retention of Records

Department Heads

Determine records disposition

Department Heads

Update Masterlist of Records

Department Heads

End

5. Records that have become disposable and obsolete documents shall be discarded. Live records when rendered obsolete shall be treated similarly as in the handling of disposable record and obsolete documents. 6. Where applicable, hard copies shall be maintained simultaneously with electronic data such as in the case of Sales Order electronically generated and other records. Data in the form of electronic media shall have a back-up file to ensure protection against damage or deterioration. Note: When backing-up files, the user shall name the files in such a way that it will be easy for him / her to open / locate / access the files. Back-up files saved in compact disc, hard disk / Server must be properly labeled. The Department Head shall ensure that both data, whether electronic or hard copies, are exactly similar to each other. However, should there be a difference between the two, the hard copy that has been approved and signed will prevail. Documents in soft copies and should be properly documented and coordinated with DDCC. 7. All Process Owners should update their respective Masterlist of Records. Proper Indexing should be followed and proper retention periods should be observed. Disposal of Records shall be covered by a Scrap Disposal Sheet and duly approved by the Division Heads.

Control of Quality Records


Document Title:
This document is confidential to the person and to INCOS Lab. Inc. It may not be copied or distributed by any other person, nor should information be used for other than the purposes intended.

Doc. No. PM-11-07

Rev. No. 0

Page 3 of 3

Section: 11 PROCEDURES MANUAL

Effectivity: January 15 , 2012

5.0 RECORDS All available records declared by the Process Owners. 6. 0 REVISION HISTORY: Revision Status 0 Effectivity Date January 15, 2012 - New release. Details Of Revision