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VERSION: A D4

CHANGE CONTROL PROCEDURE EFFECTIVE:


SYS-006 AUTHOR: B Glass
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1. PURPOSE
The purpose of this procedure is to ensure that changes to any product or process within the scope of [Company
Name]’s quality management system are planned, approved and implemented in a controlled manner, maintaining
the safety and efficacy of product and the effectiveness of the quality management system.

2. SCOPE
This procedure applies to any changes to product that has been released for manufacture and to any changes to
process that will result in a change to product or process documentation or that otherwise may potentially have an
impact on product characteristics or safety.
This procedure incorporates a procedure for deviations from planned arrangements or specifications within any part
of [Company Name]'s quality management system.
This procedure is not directly applicable to the control of changes to documents, which are covered in SYS-001. The
Document Control procedure will often be called up by change control plans under this Change Control procedure.
This is the primary document meeting the applicable regulatory requirements for Change Control as defined in
[Company Name]’s Quality System Manual (POL-001).

3. REFERENCES AND RELATIONSHIPS


SYS-001 Document Control Procedure
SYS-008 Product Development
Procedure
SYS-014 Process Validation Procedure
SYS-024 CAPA Procedure
SYS-011 Supplier Quality
SYS-010 Risk Management SYS-006 Change Control Management Procedure
Procedure Procedure SYS-026 Regulatory Affairs Manual
FRM-014 FMEA FRM-012 Change Note

FRM-013 Deviation Report


LST-009 Change Register

FRM-002 Training Record

4. DOCUMENT APPROVAL
Changes to this procedure document and associated forms and templates are to be approved by:
 Change Control Process Owner
 Quality Manager.

5. REVISION HISTORY
Date
Ver DCN What changed? Why did it change? Author
mm/dd/yy
1 mm/dd/yy YY-nnn Initial release - B Glass
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6. RESPONSIBILITIES AND AUTHORITIES


Role Responsibilities and Authorities
Change Controller Responsible for managing the overall process, including maintenance of the
Change Register and verification of change implementation.
Change Initiator Responsible for managing a change which they have initiated.
Production Process Owner Authorised to approve change proposals for changes to production process.
Product Development Authorised to approve change proposals for changes to product.
Process owner
Quality Manager Authorised to approve all other changes.

7. PROCEDURE

1. CHANGE CONTROL
Refer to Flowchart 1 and the guidance in FRM-012.
1 FRM-012 is designed to be partially filled out in Word, and partially by hand e.g. signatures and
implementation as it progresses. The form is designed with page breaks to enable the relevant pages to
be printed, then the next stage completed by hand.

2. DEVIATIONS
Refer to Flowchart 2 and the guidance in FRM-013.

8. MONITORING AND MEASUREMENT


The number of changes and deviations per month (from LST-009 Change register) is reported to Management
Review (refer to SYS-003).

9. TRAINING/RETRAINING
Role Training or Retraining Required
Change Controller Shall have a general understanding of this procedure and shall be able to
maintain LST-009 Change Register
Change Initiator Any person required to initiate a change shall be trained in all parts of the
procedure by the time that they first need to apply them, by the Quality
Manager, and shall be supervised by the Production Process Owner until they
are assessed as competent.
Production Process Owner Shall be trained and be competent in all aspects of this procedure.
Product Development Shall be trained and be competent in all aspects of this procedure.
Process owner
All staff Shall understand that they must follow documented procedures unless they are
following an approved change or deviation plan.
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10. RISK MANAGEMENT


Hazard Risk control measures
1. Uncontrolled change results in unsafe All changes to product must be approved and controlled. The
product with no traceability to the need for design verification and validation must be considered as
change. part of the change.
2. Change results in product that does not Product Development must approve all changes to product.
meet design requirements and/or is not
appropriately verified and validated
3. Uncontrolled changes to process result All changes to product must be approved and controlled. The
in a manufacturing process that is no need for revalidation of the process must be considered as part of
longer in control. the change.
4. Change to production or process is Change may not be implemented until documentation has been
made without being reflected in the revised and training completed.
relevant documentation, resulting in
potentially unsafe product, lack of
traceability and lack of consistency.
5. Change is approved without full Approval by the relevant process owners (Production and/or
understanding of implications. Product Development, dependent on the nature of the change).
6. Supplier is not able to implement the Consultation with supplier as part of process.
proposed change.
7. Changed product or process is no Consider impact on regulatory approvals and build into plan if
longer within the parameters of required.
regulatory approvals.

11. RECORDS
Record Description Storage and Retention
Change or Deviation File Collation of records associated with the Set of folders by CN or DVR
change. number, under the Change Control
Folder in default record location.
Retained indefinitely.
FRM-012, Change Note Used to approve, plan and record Part of Change or Deviation File
implementation of a change.
FRM-013, Deviation Report Used to approve, plan and record Part of Change or Deviation File
implementation of a deviation.
FRM-014, FMEA Used to analyse risks associated with the Part of Change or Deviation File
implementation of a change.
FRM-002 Training Record Used to record training associated with a Part of Change or Deviation File
change
LST-009, Change Register Spreadsheet used to allocate numbers to Living document maintained by
change notes and deviations, and to Change Controller electronically.
track their progress.
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12. FLOWCHARTS
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