SOP Title: Handling of Deviations
- Objective:
To lay down the procedure for handling of deviations in the premise
- Scope:
This procedure is applicable to all deviations observed during any stage of receipt, handling, storage, processing, testing, manufacturing and packing operations of the product (s) or material (s) including planned activities like training, audits or self inspection etc
- Responsibility:
It is responsibility of every personnel working in the respective department to report deviation to QA department and follow the procedure.
Department heads- To ensure deviation is raised, reviewed, evaluated, investigated, CAPA taken and recommendations are implemented and documented
Quality Assurance Head – To review, evaluate, analyse impact and authorize deviation, ensure investigation, CAPA taken, implementation and approval of deviation
- Accountability:
Head Quality Assurance department
- Procedure:
5.1 Definitions:
Deviation: A departure from standard practices or specifications resulting in non-conforming material /or processes, with potential to impact on product quality, safety, efficacy or data integrity. The deviation is an event occurring within the quality system, usually detected by the staff of the area in which the event occurred, which may result in non compliance with the quality system or the product requirement/contract giver.
There are two types of deviation:
Planned deviation: A planned deviation occurs, for example, when an unexpected event prevents an SOP from being followed exactly as written. Such deviations must be authorized before they are implemented and are expected to be short term solutions to a problem with immediate impact.
Unplanned deviation: An unplanned deviation is a deviation that is discovered after the procedure /process has been carried out.
To assess the risk & severity involved, the deviations are categories as followings:
Critical: A deviation that has a significant impact on the quality and/or safety of the final product
Major: A deviation that is likely to have an impact on quality of the product, but does not make any significant impact in the final quality of the product
Minor: A deviation that may not have an impact on the identity, quality, purity, strength, stability, safety and efficacy or physical characteristic of the product
Root cause: Root cause is that basic reason for an undesirable condition or problem, which if eliminated or corrected would have prevented it from existing or occurring.
Corrective action: It is action taken to eliminate the causes of an existing deviation, defect or other undesirable situation in order to prevent recurrence.
Preventive action: It is action taken to eliminate the causes of a potential deviation, defect or other undesirable situation in order to prevent occurrence and improve quality trends.
Immediate or remedial action: An action taken with immediate effect to minimize the harm to the product quality or customer before investigation.
QA Associate: Officer/executive or any personnel of QA department trained to perform duty as per this SOP
Concerned Department: Department in which the deviation has been noticed and raised as per the scope of this SOP
Concerned Department Associate: Officer/executive or any personnel of concerned department trained to perform duty as per this SOP
Designee: The person who is having adequate training, experience and qualification and assigned or delegated by the department head to perform the responsibility of deviation handling as per scope of this SOP
5.2 Procedure:
| 5.2.1 | Numbering of Deviation Report | |
| 5.2.1.1 | Each deviation noticed shall be number as mentioned below:
DRQAYYNNN where DR denotes deviation report, followed by QA denotes Quality Assurance department, followed by YY represents last two digit of the current year and last three digits NNN represents serial number as (001, 002, 003….). For example the deviation report number for first deviation of year 2024 shall be assigned as DRQA24001. |
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| 5.2.2 | Reporting of Deviation | |
| 5.2.2.1 | Any deviation from instructions or procedures should be avoided as far as possible. If deviations occur, they shall be done in accordance with this procedure. The authorization of the deviation shall be approved in writing by a designated person, with the involvement of the QC department, when appropriate. | |
| 5.2.2.3 | The department head/designee shall initiate the deviation report in the prescribed format ‘Deviation Report’. | |
| 5.2.2.4 | Initial investigation shall be made for the deviation and mentioned in the report along with reason. | |
| 5.2.2.5 | Type of deviation i.e. planned and unplanned and period for which deviation is requested to be permitted (in case of planned deviation) shall be mentioned in the report. | |
| 5.2.2.6 | Each deviation shall be logged in the current version of the ‘Deviation Log’ as per format. | |
| 5.2.2.7 | All deviation reports shall be authorized by QA head/designee prior to implementation. | |
| 5.2.3 | Evaluation and Analysis | |
| 5.2.3.1 | Deviation shall be evaluated and assessed for its potential impact on product quality, validation or regulatory commitment and on the basis of evaluation the deviation shall be categorized as minor, major or critical. | |
| 5.2.3.2 | Immediate remedial action shall be taken when the quality, efficacy or safety of the product may be compromised by the deviation. | |
| 5.2.3.3 | In case of contract manufacturing product, deviation shall be sent to the contract giver for impact assessment and approval. | |
| 5.2.3.4 | Following aspects should be considered during evaluation of deviation but not limited to:
— Scope of the validation- batch affected — Trend related to similar products, materials, equipment, testing procedures, previous complaints, previous deviations, APR and returned goods where appropriate. — A review of similar causes — Potential quality impacts — Regulatory commitment impact — Other batches potentially affected — Market actions |
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| 5.2.3.5 | Deviation shall be authorized or allowed for further processing /activities if it does not adversely affect the product quality and system/operating procedures. | |
| 5.2.3.6 | All planned deviation shall be authorised for limited batches/or with a valid period of time as appropriate. Any extension of the authorized time period should be mentioned on the deviation form. | |
| 5.2.3.7 | After depth of deviation is analysed, it has to determine whether investigation is necessary. | |
| 5.2.3.8 | If the deviation requires a permanent change in documents /system consequent to the deviation shall be handled through SOP ‘Change Control Management’. | |
| 5.2.3.9 | If a deviation leads to a non-conforming product, it shall be handled according to SOP ‘Control of Non-Conforming Product’. | |
| 5.2.3.10 | If deviation leads testing results out of specification limit then it shall be handled according to SOP, ‘Out of Specification’. | |
| 5.2.4 | Root Cause Investigation | |
| 5.2.4.1 | Thorough investigation of the deviation shall be performed to find out the root cause of the deviation. The root cause shall be investigated considering ‘5 M approach’ i. e. man, material, machine, method and mother nature (environment). | |
| NOTE:
Primary root cause is essential for determining appropriate corrective action and/ or preventive action. These root cause may help in suggesting whether inappropriate training, operation, equipment, procedure or environment have lead to failure or deviation. |
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| 5.2.4.2 | All investigations shall be completed within 30 days of initiation of the deviation unless otherwise authorized by QA. | |
| 5.2.4.3 | Summary of the root cause investigation shall be entered on the deviation form. A separate sheet may be attached for investigation with reference if required. | |
| 5.2.5 | Development of action plan (Corrective and Preventive Action) | |
| 5.2.5.1 | Based on the result of the root cause analysis, all tasks required to correct the problem and prevent reoccurrence shall be identified and included in an action plan. | |
| 5.2.5.2 | Corrective actions to be taken for the particular deviation shall be discussed with related department and mentioned in the deviation form. | |
| 5.2.5.3 | The requirement for revalidation, retraining, stability testing etc. shall be evaluated and if required, clearly mentioned in action plan. | |
| 5.2.5.4 | Similarly preventive actions to prevent occurrence of potential problem shall also be mentioned in the said form. | |
| 5.2.5.5 | Responsibilities assigned and due date for implementation shall be mentioned in action plan. | |
| 5.2.5.6 | If required, a separate CAPA may be initiated as per SOP to eliminate the existing and potential root cause after approval by QA head. | |
| 5.2.6 | Review of action Plan (CAPA) | |
| 5.2.6.1 | The CAPA shall be reviewed by all other department i. e. production, QC, QA, engineering, warehouse and admin/HR etc (as applicable). | |
| 5.2.6.2 | Finally the report shall be reviewed by head QA department. | |
| 5.2.7 | Implementation of CAPA and Follow up | |
| 5.2.7.1 | It shall be ensured that the action plan is executed and all tasks are completed as mentioned in the deviation form within the specified time frame. | |
| 5.2.7.2 | The actions that were taken shall be documented. | |
| 5.2.7.3 | The appropriateness and effectiveness of the action taken shall be evaluated and verified after implementation. | |
| 5.2.8 | Final review and Close-out | |
| 5.2.8.1 | Final review of the completed deviation report shall be done and comment shall be made with closeout date. | |
| 5.2.9 | General | |
| 5.2.9.1 | Flow for deviation handling shall be maintained as procedure mentioned above. | |
| 5.2.9.2 | A photocopy of the deviation report shall be attached to the batch documents (if required) and original shall be retained with QA department. | |
| 5.2.9.3 | All deviations and their related investigations shall be reviewed as a part of the batch record review before the batch is released. | |
| 5.2.9.4 | If similar type of minor deviations occurs frequently, these should be trended. Based on this trend, a permanent change can be proposed and implemented. | |
| 5.2.9.5 | In case of critical deviation, it shall be notified to higher management for review and decision shall be made accordingly to avoid any harm to the user. | |
| 5.2.9.6 | Any deviation in product for exports shall be communicated to the export department/ customer. | |
- Abbreviation:
| Abbreviation | Expansion |
| SOP | Standard Operating Procedure |
| DR | Deviation Report |
| QA | Quality Assurance Department |
| CAPA | Corrective And Preventive Action |
| APR | Annual Product Review |
| e.g. | Exempli gratia |
| i.e. | id est (that is) |
*Note – Ready to use SOP available in “DOWNLOAD” Section.