Pre Risk Analysis for Heating Ventilation and Air Conditioning Unit

TABLE OF CONTENTS

1. Introduction
2. Objective
3. Scope
4. Risk Assessment Approach
5. Responsibility
6. Reference Documents
7. Risk Ranking Parameters
8. Acceptance Criteria for Risk Assessment by FMEA
9. Risk Assessment as per FMEA
10. Review of Risk Assessment as per FMEA after action taken.
11. Risk Control Measures
12. Summary and Conclusion Report for Risk Assessment
13. Final Report Approval

DOCUMENT APPROVAL

This risk analysis study for the preapproval of the report by the following:

Responsibility	Department	Name	Signature	Date
Prepared by	QA
Reviewed by	Production
	Quality control
	Engineering
	Store
	QA
Approved by	Head-QA

1. Introduction

The heating ventilation and air conditioning are the technology to maintain the indoor environmental quality. Its goal is to provide thermal comfort and acceptable indoor air quality. In the pharma industry HVAC is used for product safety and to maintain environmental conditions.

2. Objective

The objective of this report is to assess the risk associated with the heating ventilation and air conditioning unit.

3. Scope

The scope of this report is limited to the risk assessment associated with the heating ventilation and air conditioning unit.

4. Risk Assessment Approach

Risk assessment is carried out as per the FMEA (Failure mode effects analysis) method.

5. Responsibility

Quality Assurance Engineering Production Quality Control Store

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6. Reference Documents

1. ICH Q9-Quality Risk Management

Background

PharmaGuide Limited intends to start a manufacturing facility of Tablets & Dry syrup at _______ Risk assessment is a part of corporate quality assurance. Post Quality Risk assessment of “HVAC” is done to check the system is capable of providing quality air. The company is maintaining areas as per ISO 8 in the core production area.

All the AHUs are qualified during the installation and prequalified as per ISO 14644.

AHUs are installed on the service floor of the main building. AHUs are maintained with 80-95% recirculation and 5-20% fresh air supply. The fresh air supply is passed through the 10-micron filter. A dedicated AHU is provided to the microbiology area.

7. Risk Ranking Parameters

7.1 Rating Parameters for Severity

Effect	Scale	Description
No effect	1	No effect on output
Very slight	2	Customer not annoyed
Slight	3	Slight
Minor	4	Minor effect on performance
Moderate	5	Moderate effect on performance
Significant	6	Partial failure but operable
Major	7	Product performance was severely affected, but some operability and safe
Extreme	8	Very dissatisfied, the product is inoperable but it safe
Serious	9	Potentially hazardous effect, time-dependent failure
Hazardous	10	Hazardous effect, safety-related sudden failure

7.2 Rating Parameters for Occurrence

Occurrence	Scale	Description
Almost never	1	Failure unlikely; history shows no failures
Remote	2	A rare number of historical failures.
Very Slight	3	Very few failures likely
Slight	4	Few failures likely
Low	5	Occasional number of failures likely
Medium	6	Medium number of failures likely
Moderately High	7	Moderately high number of failures likely
High	8	High number of failures likely
Very High	9	A very high number of failures likely
Almost certain	10	Failure almost certain

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7.3 Rating parameters for Detection control

Detection	Scale	Description
Almost certain	1	Proven detection methods with high reliability
Very High	2	Proven detection methods available
High	3	Detection tools have a high chance of detecting methods
Moderately High	4	Almost certain not to detect failure
Medium	5	Detection tools have a moderate chance of detecting defect
Low	6	Detection tools have a low chance of detecting failure
Slight	7	Detection tools may not detect failure
Very Slight	8	Detection tools will probably not detect failure
Remote	9	Detection tools most likely will not detect failure
Impossible	10	Failure not detected

8. Acceptance Criteria for Risk Assessment by FMEA

Acceptance criteria for FMEA are as follows:

Sr. No.	RPN Rating	RPN Category	Action Status
1.	≥ 76	Critical	CAPA Required
2.	51 to 75	Major	CAPA Required
3.	26 to 50	Moderate	CAPA Required
4.	Up to 25	Minor	Not applicable

9. Pre Risk Assessment as per FMEA

Name of facility / Engineering / Equipment / Process / Operation: HVAC

9.1 Review of Risk Assessment as per FMEA after Action Taken:

Action Results					Remarks
Action Taken	Severity	Occurrence	Detection	RPN

10. Risk Control Measure

Investigation/ findings: (an extra sheet can be used if space is insufficient)

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Corrective Action: (an extra sheet can be used if space is insufficient)

_____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

(Sign/Date)

11. Summary & Conclusion Report for Risk Assessment

Summary

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Conclusion

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12. Final Report Approval

The final report shall be signed after identifying all the risks and critical control parameters. All the reports or documents have been attached to the respective report (if applicable).

The signature in the block below indicates that all the control measures taken are documented and have been reviewed and found to be acceptable.

Department	Name	Designation	Signature	Date
Quality assurance
Production
Quality control
Engineering
Store
Head-QA

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