| Department | Environmental, Health and Safety | Document no | EHS-055 | ||
| Title | Environmental Aspect Register | ||||
| Prepared by: | Date: | Supersedes: | |||
| Checked by: | Date: | Date Issued: | |||
| Approved by: | Date: | Review Date: | |||
1. AFFECTED PARTIES
All Environment, Health and Safety personnel
2. PURPOSE
This SOP describes the procedure for establishing and updating an Environmental Aspects Register for the GMP site. It outlines steps for identifying, rating and reviewing environmental aspects and impacts.
3. SCOPE
This SOP applies to all activities, processes, product and services, which impact or can, have a beneficial or adverse impact on the environment. This includes contractors and raw materials, intermediate and final products, and by-products.
4. RESPONSIBILITY \ BUSINESS RULES
GMP site is required to establish and maintain this procedure to identify the environmental aspects of its activities, products or services that it can control and over which it can be expected to have an influence, in order to determine those that can or have significant impacts on the environment. Teh site shall ensure that the aspects related to these significant impacts are considered in setting its environmental objectives.
The Environmental Aspects Register review will be conducted on an annual basis.
4.1 EHS Manager
The EHS Manager shall ensure this procedure is followed and that relevant stakeholders are consulted in the establishment of the Environmental Aspects Register and subsequent actions arising from the Register.
4.2 Site Leadership Team
The team shall assist the EHS Manager in the development and maintenance of the
Environmental Aspects Register and shall support the timely completion of subsequent actions arising from the Register.
4.3 Significant Impacts
Impacts shall be deemed significant if the following conditions exist after consideration of existing controls (see Step 5.7).
5. PROCEDURE
5.1 List Activities
A list of all applicable, activities, products and services for the site with actual or potential environmental consequences has to be generated. This will be the basis for creation of the
Environmental Aspects Register.
5.2 Aspect
The associated environmental aspects have to be identified for each activity. Aspects are defined as the element of site activities, products or services that can interact with the environment. Aspects are to be identified in consultation with area managers, supervisors or colleagues working in the area or any applicable stakeholder. The activity can involve design and development, manufacturing processes, packaging and transportation, environmental performance and contractors and supplier practices (refer to SOP for Contractor and Visitor Management for further information), waste management, extraction and distribution of raw materials / natural resources, wildlife and biodiversity as well as distribution and use of end-of life of products. The following in addition must be considered whenever identifying the aspect.
EHS Policy
Internal performance criteria
Legislative and regulatory requirements
Results from past audits, which reviewed current procedures and practices
Evaluation of feedback from incident investigations
Sensitive areas / issues around the site
Each aspect can be categorised into one or more of the following aspect categories:
Air emission
Waste water
Solid waste
Hazardous waste
Energy
Natural Resources
Community Health (Noise, water, air)
Soil / Water Stream (ground water, surface water)
Other
5.3 Related Impacts
For each aspect, the related impact that the aspect has or could have on the environment must be identified.
Impacts are defined as changes to the environmental either adverse or beneficial that are a whole or partial result due to an aspect.
Impacts can be associated with normal operating conditions, abnormal conditions including start-up and shut down, and emergency situations and accidents. The status of impacts are classified as shown in Table 1.
Table 1: Status of impacts
| Normal | Conditions, which exist as a result of routine operations according to normal operating procedures. Identify using the letter ‘N’. |
| Abnormal | Conditions, which exist as a result of non-routine operations including start-ups and shut down conditions. Identify using the letter ‘A’. |
| Emergency | Conditions that represent an immediate or potential emergency situation. These include accidental release of wastewater, chemicals or products into environment. Identify using the letter ‘E’. |
Impacts that are identified can also be categorised as
Actual Impacts (these are impacts that occur as a direct result of the aspect)
Possible impacts (due to failure of process and systems)
Future impacts (considering proposed changes and additions)
The nature of impact should be considered so as to identify the appropriate control measure to mitigate the impact.
5.4 Rating Scheme
A rating scheme has been devised to determine quantitatively the level of impact has for a particular aspect. This rating scheme is applied before and after controls are applied to a particular impact. The rating scheme is as below:
Table 2: Severity Rating
| Category | Rating number | Definition |
| Severity | 1 | No injury or first aid only, no environmental or business impact. |
| 2 | Short term illness or injury, minor environmental or business impact. | |
| 3 | Long term illness or serious injury, major environmental or business impact. | |
| 4 | Kill or permanent disability or ill health, critical environmental or business impact. |
Table 3: Likelihood Rating
| Category | Rating number | Definition |
| Likelihood | 1 | Very unlikely (could happen but probably never will) |
| 2 | Unlikely (could happen but very rarely) | |
| 3 | Likely (could happen sometime) | |
| 4 | Very likely (could happen anytime) |
Table 4: Improvement Opportunities
| Category | Rating number | Definition |
| Improvement Opportunities | 1 | None |
| 2 | Low | |
| 3 | Medium | |
| 4 | High |
Table 5: Public Perceptions
| Category | Rating number | Definition |
| Improvement Opportunities | 1 | Does not exist |
| 2 | Some | |
| 3 | Mild | |
| 4 | Strong public perceptions |
Table 6: Public Perceptions
| Category | Rating number | Definition |
Regulatory Implications (Regulatory) | 1 | No non compliance |
| 2 | Excursion from regulations can occur but not cause a non conformance | |
| 3 | Excursion from regulations can occur but trigger a notification requirement | |
| 4 | Excursion from regulations can occur and result in non compliance |
Table 7: Exposure Rating
| Category | Rating number | Definition |
| Exposure Rating | 1 | One off |
| 2 | Annually | |
| 3 | Monthly | |
| 4 | Weekly / Daily |
5.5 Control Measures
For each activity, product category, or service of an aspect, any control measures currently existing in place must be described and any control that might be considered or necessary must be highlighted as well.
The rating scheme is performed using the formula in Section 5.4 before existing controls are considered and again after existing controls are implemented as part of the Environmental Aspects Register
5.6 Significant Impacts
Aspects with a final rating of 11 or more are considered significant. It should be noted that all aspects, which are regulated under legislation or corporate guidelines, must be rated as a significant impact. Also all aspects that can cause severe environmental damage must also be rated as a significant impact.
5.7 Opportunities and Actions
For each Impact, possible opportunities for improvement and implementation of controls must be done in consultation with relevant parties and stakeholders. Based on identified opportunities or other appropriate information, actions plans must be developed and executed wherever possible to ensure that existing controls are in place and new controls are introduced.
5.8 Annual Review
The EHS Department on an annual basis shall review the Environmental Aspects Register.
6. DEFINITIONS / ACRONYMS
Not applicable
7. SUMMARY OF CHANGES
| Version # | Revision History |
| EHS-055 | New |