SOP For Quality Risk Management 1.0 PURPOSE To lay down the procedure for Quality Risk Management in case of identification/anticipation...
SOP For Quality Risk Management
1.0 PURPOSE
To lay down the procedure for Quality Risk Management in case of identification/anticipation of a risk that may have a direct or indirect impact on the Strength, Identity, Safety, Purity, and Quality (SISPQ) of the products.
2.0 SCOPE
This SOP shall apply to all areas of the manufacturing site
3.0 RESPONSIBILITY
3.1 User Department personal shall be responsible for identifies the risk in the departmental operations and prepares the Risk assessment document.
3.2 User Department Head /Designee shall be responsible for review the Risk assessment document.
3.3 QA Executive/Designee shall be responsible for assign document numbers to the “Risk Assessment’’.
3.4 Head Quality Assurance /Designee shall responsible for review and approve the risk assessment document.
4.0 PROCEDURE
4.1 Evaluation of risk to quality shall be based on scientific knowledge and it shall ultimately be linked to the protection of patients.
4.2 Quality risk management is a systematic process for the assessment, control, communication, and review of risks to the quality of the drug (medicinal) product across the product lifecycle.
4.3 Quality risk management program shall be performed on various aspects relating to storing, manufacturing, packing, testing, and various other GMP aspects were ever identified and appropriate.
4.4 Risk assessment shall consist of identification of hazards, analysis, and evaluation of risks associated with exposure to those hazards.
4.5 Risk management can be initiated by any personnel within the facility (Storing, manufacturing, packing, testing) with a well-defined risk question or problem description.
4.6 An overview of a typical quality risk management process is presented in the “Flow chart for Typical Quality risk management Process” (Refer Annexure No.: V).
4.7 Risk Management
4.7.1 The risk may be identified by any individual working in the organization. The individual shall ensure that risk to quality shall be based on scientific knowledge and it shall ultimately link to product quality and protection of the patient.
4.7.2 The concerned department heads or their designees shall review identified risks and for further evaluation FMEA, HACCP, or any other appropriate risk management tools may be adopted.
4.7.3 Risk assessment committee (comprising of technically qualified individuals from various departments, Refer Annexure No.: VI) shall review the identified risk and evaluate the same.
4.7.4 Control measures proposed at the time of risk assessment shall be reviewed and approved by the Head QA or his designee; shall be put forward for routine operations.
4.7.5 Control measures, as an outcome of risk assessment, shall be communicated to various personnel concerned in the areas.
4.7.6 Incorporation of control measures and impact of the same shall be reviewed by individual department heads and risk committees periodically.
4.7.7 For Probable risks involved in various operations refer to “Probable risks involved in various operations” (Refer Annexure No.: III)
4.8 Risk Assessment Tools
4.8.1 Failure Mode Effects Analysis (FMEA)
4.8.1.1 Assign FMEA team members and team leaders. Identify failure modes for process/ system/ the facility under evaluation.
4.8.1.2 Determine the main components of the system/ process & identify the worst potential “Effect” or consequences of each of the failure modes.
4.8.1.3 Determine The severity of the risk of failure (S), rank the severity qualitatively and quantitatively. Identify and note contributory factors for each failure mode.
4.8.1.4 Determine the probability of occurrence (O) and assign score accordingly Identify the “Existing Controls” in the place to minimize the risk.
4.8.1.5 Determine the detectability of risk and assign the score.
4.8.1.6 Calculate the Risk Priority Number (RPN) by multiplying the Severity X Occurenece X Detectability.
4.8.1.7 The further evaluation shall be done as per guidance provided in “Guidance for performing Risk Assessment “(Refer Annexure No.: IV).
4.8.1.8 Arrive at the conclusion to the risk process and summarize.
4.9 Hazard Analysis and Critical Control Points (HACCP)
4.9.1 HACCP Provides a systematic approach for assuring product quality, reliability, and safety.
4.9.2 Assign Risk Assessment team members and team leader. Identify possible hazards/ threats of a process under evaluation.
4.9.3 Arrive at the consequences of the failure mode.
4.9.4 Determine Severity of risk of failure (S), rank the severity qualitatively and quantitatively.
4.9.5 Determine the probability of occurrence (O) and assign scores accordingly.
4.9.6 Determine the detectability of risk and assign the score.
4.9.7 Describe available control points, determine whether critical control points are acceptable.
4.9.8 Propose any further critical control points required to mitigate the risk.
4.9.9 For rating on individual parameters refer to “Guidance for performing Risk Assessment” (Refer Annexure No.: IV).
4.9.10 Perform risk assessment as per “Risk Assessment For” (Refer Annexure No.: I).
4.9.11 Arrive at the conclusion to the risk process and summarize (Refer Annexure No.: II).
4.10 Risk Assessment Numbering
4.10.1 The Risk Assessment number shall be given as - RA/YY/ XX /ZZZ-AA
4.10.2 QA shall assign document number to “Risk Assessment” and mention the details in ‘’Risk Assessment Log Register’’ (Refer Annexure No.: VII) and maintained in the QA department.
4.11 Risk assessment document shall be revised with the change in revision number in following conditions but not limited to,
4.11.1 Modification or up-gradation of the Equipment / Instruments.
4.11.2 Major breakdown/replacement of major parts of Equipment / Instrument.
4.11.3 New risks/failure modes are identified.
4.11.4 Change in process / activity / Environmental conditions.
4.12 DEFINITIONS
4.12.1 Detectability: The ability to discover or determine the existence, presence, or fact of a hazard.
4.12.2 Harm: Damage to health, including the damage that can occur from loss of product quality or availability.
4.12.3 Hazard: The potential source of harm.
4.12.4 QUALITY RISK MANAGEMENT: A systematic process for the assessment, control, communication, and review of risks to the quality of the drug (medicinal) product across the product lifecycle.
4.12.5 QUALITY SYSTEM: The sum of all aspects of a system that implements quality policy and ensures that quality objectives are met.
4.12.6 RISK: Combination of the probability of occurrence of harm and the severity of that harm.
4.12.7 RISK ACCEPTANCE: The decision to accept risk.
4.12.8 RISK ANALYSIS: A systematic evaluation of the risk of a process by determining what can go wrong (risk identification), how likely is it to occur (risk estimation/assessment), and what the consequences are, and whether this has any impact on the quality of the final product (risk evaluation/impact analysis).
4.12.9 RISK ASSESSMENT: Systematic process of organizing information to support a risk the decision to be made within a risk management process.
4.12.10 RISK COMMUNICATION: Exchange or sharing of information about risk and risk management between the decision-maker.
4.12.11 RISK CONTROL: Actions of implementing risk management decisions
4.12.12 RISK EVALUATION: Compares the estimated risk against given risk criteria using a quantitative or qualitative scale to determine the significance of the risk.
4.12.13 RISK IDENTIFICATION: Systematic use of information to identify potential sources of harm (hazards) referring to the risk question or problem description.
4.12.14 RISK MANAGEMENT: Systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, and communicating risk.
4.12.15 RISK REDUCTION: Actions taken to lessen the probability of occurrence of harm and the severity of that harm.
4.12.16 RISK REVIEW: Step in the risk management process for taking account of new knowledge and experiences.
4.12.17 SEVERITY: Measure of the possible consequences of a hazard.
No comments