INTERNAL POLICY AND PROCEDURE (IPP)

Titel/Description: Document Data and Records Control

Code Number: Effective Date: Replaces Number: Applies To: SASC LAB
GEN-017-01 01/11/2024 New

REVIEW AND APPROVALS Signature Date

Prepared by: Abdulrahman Shoaib, Quality Officer 01/11/2024

Reviewed by: Ahmed Othman, Supervisor 01/11/2024

Dr. Zhour Ibrahim, Technical and Medical
Approved by: 01/11/2024
Director

Review /
Name Signature Summary of Changes
Revision Date

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 INTERNAL POLICY AND PROCEDURE (IPP)

Titel/Description: Document Data and Records Control

Code Number: Effective Date: Replaces Number: Applies To: SASC LAB
GEN-017-01 01/11/2024 New

1. PURPOSE

1.1 To provide a standardized system to establish, and maintain procedures to control

documents, records and data that form part of the quality system of ISO/IEC 17025.

2. DEFINITIONS

2.1 Quality system documents: Quality system documents shall be uniquely identified
with date of issue, and /or revision identification, page numbering, the total number of
pages or mark to signify the end of the document and the issuing authority.

2.2 Document: can be generated internally or from external sources and can be in any
media such as Hard copy written, Electronic, digital, analog and/or photographic.
Type of documents:

2.2.1 Regulations.
2.2.2 Standards.
2.2.3 Normative documents.
2.2.4 Test and and/or calibration methods.
2.2.5 Drawings.
2.2.6 Software.
2.2.7 Specifications.
2.2.8 Instructions.
2.2.9 Manuals.
2.2.10 Policy statements.
2.2.11 Procedures.
2.2.12 Calibration table.
2.2.13 Charts.
2.2.14 Textbooks.
2.2.15 Posters.
2.2.16 Notices.
2.2.17 Memoranda.
2.2.18 Plan.

2.3 Control of Records are accumulations of data and can be in any media such as hard
copy or electronic media. Records can be Quality and Technical:

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 INTERNAL POLICY AND PROCEDURE (IPP)

Titel/Description: Document Data and Records Control

Code Number: Effective Date: Replaces Number: Applies To: SASC LAB
GEN-017-01 01/11/2024 New

2.3.1 Quality records: are records from internal audit, management reviews,
corrective and preventive action records, and Proficiency testing reports.

2.3.2 Technical Records: are accumulation of data and information which result
from carrying out tests and/or calibration and which indicates whether
specified quality or process parameters are achieved, they may include:

2.3.2.1 Forms.
2.3.2.2 Contracts.
2.3.2.3 Staff records.
2.3.2.4 Books.
2.3.2.5 Check sheets.
2.3.2.6 Work notes.
2.3.2.7 Control Graphs.
2.3.2.8 Test reports.
2.3.2.9 Calibration.
2.3.2.10 Certificates.
2.3.2.11 Customers notes.
2.3.2.12 Test reports and calibration certificates to customers.
2.3.2.13 Observations, data, and calculations shall be clearly and permanently
recorded and identifiable to the specific job at the time they are made.

2.4 Data: information generated from instruments upon performing a test.

2.5 External documents (example: ISO standards) is reviewed and updated on annual
basis by an assigned person (s) from Technical and Medical Director to confirm that
we have the latest version of the documents and to ensure continuing suitability,
implementation and conformance with the management system and ISO/IEC 17025
requirements.

3. Responsibilities

3.1 It is the responsibility of the supervisor to review laboratory policies and procedures.
3.2 It is the responsibility of the Technical and Medical Director to approve policies and
procedures.

4. POLICY

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 INTERNAL POLICY AND PROCEDURE (IPP)

Titel/Description: Document Data and Records Control

Code Number: Effective Date: Replaces Number: Applies To: SASC LAB
GEN-017-01 01/11/2024 New

4.1 Guidelines for the control of document, technical and quality records and data are
illustrated below. Disposal scheduling is mentioned in retention list schedule.

4.2 Document Control:

4.2.1 All approved Laboratory Internal Policy and Procedures (IPPs), forms ,and
external documents must be posted in the laboratory share drive, back up PDF
soft copy in external hard drive and hard copy as per location in the internal
and external documents lists.

4.2.2 All documents must be kept for five years.

4.2.3 No pencil should be used.

4.2.4 Raw data must be signed with date and kept.

4.2.5 Use logbook in each sub-section.

4.2.6 Where possible connect instruments with printers.

4.2.7 All documents issued to personnel within lab shall be reviewed and approved
for use prior to issue.

4.2.8 Invalid or obsolete documents are archived in a place that the staff does not
have access to them.

4.2.9 Obsolete documents will be handled as mentioned in the table.

4.2.10 Suitably mark obsolete document if retained for legal or knowledge purposes.

4.2.11 The changes to documents shall be reviewed and approved by the same
function that performed the original review unless specifically otherwise
designated. The designated personnel shall have access to the original
information to base their review and approval.

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 INTERNAL POLICY AND PROCEDURE (IPP)

Titel/Description: Document Data and Records Control

Code Number: Effective Date: Replaces Number: Applies To: SASC LAB
GEN-017-01 01/11/2024 New

4.2.12 Technical and Medical Director or designee is required to perform review of

internal policies and procedures (IPPs) biennially (Every two years).

4.2.13 Changes in the documents is controlled by authorized personnel who can

access and modify the documents. Unauthorized staff can read only in the
document.

4.2.14 All staff shall acknowledge all general IPPs and forms, and the staff in each
section should acknowledge the related IPPs and forms, by singing the
laboratory acknowledge form. In case any changes in the IPPs the staff should
sing the acknowledge laboratory form again.

4.3 Record Control: the lab shall establish and maintain procedures for identification,
collection, indexing, access, filling, storage maintenance and disposal of quality and
technical records.

4.3.1 Quality records:

4.3.1.1 All records stored and retained in a way they can be easily retrieved in a
suitable environment to prevent damage and loss.

4.3.2 Technical records:

4.3.2.1 When mistakes occur in the records, each mistake shall be crossed out, not
erased, made illegible not deleted, and the correct value entered alongside.
All such alterations to records shall be signed or initialed by person
making the correction. In case of computer-collected data from analytical
instruments, all data must be backed up to an external hard desk every two
weeks and label properly, in addition to these on hard disk. Since all
records in SASC Share drive, the backup will be done by ITA on Daily
basis through server.
4.3.2.2 The records of each test results shall contain sufficient information to
facilitate identification of factors affecting uncertainty and to enable to be
repeated under condition that close to original.

4.3.3 Data control:

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 INTERNAL POLICY AND PROCEDURE (IPP)

Titel/Description: Document Data and Records Control

Code Number: Effective Date: Replaces Number: Applies To: SASC LAB
GEN-017-01 01/11/2024 New

4.3.3.1 This is related to testing and calibration of data, it will be applied for data
entry or collection, data storage, data transmission and data processing, the
following shall be ensured.
4.3.3.2 Calculations and data transfers shall be subject to appropriate checks in a
systematic manner.
4.3.3.3 When computers or automated equipment are used for acquisition,
processing, recording, reporting, storage or retrieval of test or calibration
data the following shall be ensured.
4.3.3.4 Computer software developed by user is documented in sufficient detail
and is suitably validated as being adequate for use.
4.3.3.5 All laboratory data are confidential and must be protected.
4.3.3.6 Computers and automated equipment are maintained to ensure proper
functioning and provided with environmental and operating conditions
necessary to maintain the integrity of the test and calibration data.
4.3.3.7 Commercial off - the shelf software may be considered to be validated if it
is used within designed application range.

5. TRAINING:

5.1 When a technical procedure is revised, the staff performing the procedure must be
retrained, and deemed competent. Retraining is not necessary if the revision is minor
(e.g., correction of clerical errors, wording changes to improve clarity, etc.).

5.2 All staff members listed in authorized column in the following retention list schedule
must be trained on how to control documents, records, and control of data as per
retention List.

5.3 All staff are trained about the content and location of documents.

6. Retention List Schedule:

6.1 All documents, records, and data in the Laboratory whether hard or soft copy are
confidential and protected.

6.2 Soft copies are protected by computer password and share drive limited access to
authorized personnel. Analytical equipment software is locked.

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 INTERNAL POLICY AND PROCEDURE (IPP)

Titel/Description: Document Data and Records Control

Code Number: Effective Date: Replaces Number: Applies To: SASC LAB
GEN-017-01 01/11/2024 New

6.3 Hard copy located in SASC Lab. Protected by limited access door to authorized
Personnel.

6.4 All records will be archived for five years.

6.5 The code number of some general forms related to both clinical and non-clinical IPPs
will be as per document control of the clinical forms.

7. IPP Format

7.1 The SASC laboratory IPPs will be divided as flows:

7.1.1 General IPPs.

7.1.2 Trace elements IPPs.
7.1.3 Chromatography IPPs.
7.1.4 Microbiology IPPs.

7.2 The abbreviation for the type of IPP:

7.2.1 GEN: for General.

7.2.2 TE: for Trace Elements.
7.2.3 CHR: for Chromatography.
7.2.4 MIC: for Microbiology.
7.2.5 P: for Procedure.
7.2.6 OPMN: for Operation and maintenance.

7.3 IPPs code numbering for general IPPs:

7.3.1 GEN-00X-0Y
7.3.2 00X: Serial number of IPP.
7.3.3 0Y: Revision number.
7.3.4 Example: GEN-010-01.

7.4 IPPs code numbering for non-general IPPs:

7.4.1 ABC-CD-00X-0Y.

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 INTERNAL POLICY AND PROCEDURE (IPP)

Titel/Description: Document Data and Records Control

Code Number: Effective Date: Replaces Number: Applies To: SASC LAB
GEN-017-01 01/11/2024 New

7.4.2 ABC: abbreviation of the section (e.g.: TE, CHR or MIC).

7.4.3 CD: abbreviation of the type of IPP within the section (e.g.: P: for procedure
and OPMN: for operation and maintenance).
7.4.4 00X: serial number of IPP.
7.4.5 0Y: Revision number.
7.4.6 Example: TE-P-008-01.

7.5 Forms Code Numbering:

7.5.1 The forms are given the same code number of the IPP that they belong to
followed with FX and then the revision number of the form.
7.5.2 F: abbreviation for form.
7.5.3 X: form number.
7.5.4 Example: GEN-017-01-F1 (Rev.1).
7.5.5 All forms are placed in a separate folder named as form folder.

7.6 Formatting the header and footer of the IPP:

7.6.1 The header will have the following information of the IPP:

7.6.1.1 Title/description of the IPP.

7.6.1.2 Code number.
7.6.1.3 Effective date.
7.6.1.4 Replaces number.
7.6.1.5 Applies to.
7.6.1.6 The font will be Timer New Roman.

7.6.2 The footer will have the following information of the IPP:

7.6.2.1 Code number.

7.6.2.2 Number of pages. In the format (Page number of total number of pages),
example (Page 8 of 9).

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 INTERNAL POLICY AND PROCEDURE (IPP)

Titel/Description: Document Data and Records Control

Code Number: Effective Date: Replaces Number: Applies To: SASC LAB
GEN-017-01 01/11/2024 New

8. FORMS

8.1 Internal Document GEN-017-F1.

8.2 External Document GEN-017-F2.
8.3 Laboratory Staff Acknowledgment form GEN-017-F3.

9. REFERENCES:
9.1 ISO/IEC 17025 Standard.

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