Creating a Standard Operating Procedure for Document and Data Control is crucial for ensuring consistency, accuracy, and compliance in managing organizational information. Here’s a template you can use as a starting point. Adjust it based on the specific needs and processes of your organization.
Objective
This procedure ensure that document within the scope of ISO 9001are controlled so that current version of all document is readily available at the point of application.
Scope
This procedure will apply to all quality environmental, Lab management system document like, all manual, procedure, work instruction standard and specification format etc.
Procedure
Document Numbering System
The numbering scheme of all documents will consist of nine numbers.
WW/XX/YY/ZZZ
First WW shows the department from where the document is originated.
The codes of departments are
QM: For Quality Management System
MM: For Material Management
PR: For Production
QC: For Quality Control
QA: For Quality Assurance
MN: For Maintenance
AC: For Accounts
MK: For Marketing
HR: For Human Resources (Administration & Personnel)
RD: For R & D Department
EM: For Environmental Management System
IT: For Information Technology
Second XX shows the section or broad category of document, the coding system will be
TB: For Tablet Section
SP: For Syrup Section
OC: For Ointment, Cream, lotion & solutions Section
ED: For Ear Drops
GS: For Glycerine suppository.
FG: For Finished Goods Store
RM: For Raw Materials Store
PM: For Packaging Materials Store
FM: For Formats
CL: For Calibration
AP: For Analytical Procedure
GN: For General Documents
The third YY shows the type of documents, the coding system will be
CA: For Certificate of Analysis
EQ: For Equipment
SP: For Standard operating procedure
FM: For Formats
SN: For Specification
SD: For Standards
JD: For Job Description
IS: For Inactive substances
AS: For Active substances
IP: For Installation qualification protocol
IR: For Installation qualification report
OP: For Operation qualification protocol
OR: For Operation qualification report
PP: For Performance qualification protocol
PR: For Performance qualification report
MP: For Standard manufacturing procedure
MO: For Standard manufacturing order
FD: For Formulation development
The fourth ZZZ will be sequential numbered, which starts from 001 and increases numerically.
All manuals will not contain any number.
Storage procedure for Electronic data
All data will be typed & stored in Microsoft Word Documents electronically, either text or tables. Last syllable of every document number will be taken along with its number separated by a hyphen and document name will be written with title format followed by a single space. For example the document name for the current SOP is QA/GN/SP/058. Now the last syllable will be “SP” and its document Number is “058”, so it will be written as using a hyphen between SP and 058 as;
SP-058Now by placing a single space, the document name would be written as;
SP-058 Document and Data Control
The title style is as; the only first alphabet should be in capital and the rest as small. Then this electronic copy will be submitted to QA.
Document format and structure
All the quantity, environmental, lab management system procedure will follow the following structure
Objective: The aim of the procedure.
Scope: What the procedure does or not cover.
Procedure: Description of the activity to be carried out, by whom, and in what sequence.
Related document: What documentation is needed?
Revision History: Describe the previous revision record of the document.
Top right corner of all procedures and other documents will contain the following information.
Document number :
Issue date:
Revision date / #:
Page #:
Top right corner of all manual will contain the following information
Issue number
Date of release
Page number
Top right corner of forms and formats contain the following information
Document number:
Issue Date/ number:
The title page of procedure and all documents will contain the name of procedure and signature of writing, checking and approving authority with their respective designations.
Document Approval
- Quality policy will be approved by Plant Manager of the company.
- All manuals will be approved by Plant Manager.
- All procedures will be approved by Manager Quality Assurance.
- All specifications / standards will be approved by QC Manager, Production Manager & Manager Quality Assurance.
Document Issuance
- The entire documents will be issued by management representative (MR/EMR) environmental management representative.
- Management representative/ EMR will file a master copy of each document in his office.
- Management representative/ EMR will make department wise master list of every document and get receiving signature of all persons to whom the document are disturbed.
- Management representative/ EMR also make a distribution list of every document and get receiving signature of all personnel to whom the document are distributed.
- Initially all the document will be issued in issue # 1. After every change this issue number will be increased by 2, 3 and so on.
Controlled Document
- All controlled documents will be red stamped as CONTROLLED DOCUMENT. EMR / Management representative or his nominee is responsible to stamp the documents.
- CONTROLLED DOCUMENT with red stamp will be submitted to QA department.
- Photocopies will be distributed to the respective department for further use.
- All documents which do not have the stamp will be considered as “Uncontrolled”.
- Management representative/ EMR has the authority to issue uncontrolled documents for external or training purpose but all these document will be stamped as uncontrolled.
- Management Representative/EMR has the authority to do minor correction manually with signature.
Document changes
- Amendments in document can be authorized by the authorities who initially approved the document.
- Any request for amendment will be sent to Management Representative/EMR through change control form (QA/FM/GN/020).
- Management Representative/EMR will then verify the Change Details that clearly defines the indication of importance and urgency.
- Then electronic copy of the respective document (already submitted to QA) will then be provided to the in-charge of respective department.
- In-charge of respective department will made change in the document and will submit both electronic copy and the hard copy of the document to QA and Management Representative/ EMR.
- Management Representative/ EMR will then verify the change and then returned to the respective in-charge for prepared by, checked by and approved by initials.
Removal of Obsolete documents.
- After any amendment in document, MR will issue the new version with the collection of obsolete document.
- MR/EMR will dispose all the copies of obsolete document and file one copy in “obsolete document file” for record purposes.
Controlling of standard/ specifications.
Standards and specification will also be controlled by putting Red Stamp.
Control Records.
- All the record generated for the compliance of ISO 9001 will fall under this procedure.
- All the records are identified with their name and number.
- All the section in-charge ensures that record is submitted to QA.
- The designated QA person will maintains a list of quality records defining the record number, name location and retention period.
- The record is files and indexed in such a manner that can be retrieved very easily. For this purpose record are kept batch wise or date wise or report number wise.
- The personnel responsible for generation of record are responsible to ensure that records are legible.
- After the retention period (minimum two years), department head (QA) ensures that records are disposed off properly by the method of shredding, burning or land fill.
- Retention period for Batch Manufacturing Records BMRs will be as one year after the expiry date. Audit branch will ensure the disposal off the BMRs by the method of shredding, burning or land fill.
Revision History: First issued