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

Scope

Procedure

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.

Document format and structure

Document Approval

1. Quality policy will be approved by Plant Manager of the company.
2. All manuals will be approved by Plant Manager.
3. All procedures will be approved by Manager Quality Assurance.
4. All specifications / standards will be approved by QC Manager, Production Manager & Manager Quality Assurance.

Document Issuance

1. The entire documents will be issued by management representative (MR/EMR) environmental management representative.
2. Management representative/ EMR will file a master copy of each document in his office.
3. 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.
4. Management representative/ EMR also make a distribution list of every document and get receiving signature of all personnel to whom the document are distributed.
5. 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

1. All controlled documents will be red stamped as CONTROLLED DOCUMENT. EMR / Management representative or his nominee is responsible to stamp the documents.
2. CONTROLLED DOCUMENT with red stamp will be submitted to QA department.
3. Photocopies will be distributed to the respective department for further use.
4. All documents which do not have the stamp will be considered as “Uncontrolled”.
5. Management representative/ EMR has the authority to issue uncontrolled documents for external or training purpose but all these document will be stamped as uncontrolled.
6. Management Representative/EMR has the authority to do minor correction manually with signature.

Document changes

1. Amendments in document can be authorized by the authorities who initially approved the document.
2. Any request for amendment will be sent to Management Representative/EMR through change control form (QA/FM/GN/020).
3. Management Representative/EMR will then verify the Change Details that clearly defines the indication of importance and urgency.
4. Then electronic copy of the respective document (already submitted to QA) will then be provided to the in-charge of respective department.
5. 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.
6. 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.

1. After any amendment in document, MR will issue the new version with the collection of obsolete document.
2. 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.

Control Records.

1. All the record generated for the compliance of ISO 9001 will fall under this procedure.
2. All the records are identified with their name and number.
3. All the section in-charge ensures that record is submitted to QA.
4. The designated QA person will maintains a list of quality records defining the record number, name location and retention period.
5. 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.
6. The personnel responsible for generation of record are responsible to ensure that records are legible.
7. 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.
8. 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.