Product Stewardship Requirements

 

Identify and Consult Relevant Stakeholders on The Recommended Actions to be Taken to Conform with Product Stewardship Requirements

The stakeholders for consultation on the recommended actions to be taken to conform with Product Stewardship Requirements were identified as:

Employees and contractors

Local community organisation

The representation from employees and contractors participation have lead to the development, implementation, review and improvement of HSE initiatives and programmes, the establishment of HSE goals and targets, and the review and verification of HSE performance.

Proactive and open consultation and communication with governments, authorities and other organisations is maintained in order to contribute to the development of public policy, relevant legislation and educational initiatives in relation to sustainable development

 Review Records on Implementation of Product Stewardship Management

There are many examples of records which can be review to demonstrate the organization’s implementation of product stewardship management.

However, in this assignment, i will only discuss the following records which include:

• Record of use of chemical during product development
• Record of disposal of waste chemical

An effective control of chemical risks at the workplace requires an efficient flow of, information from the manufacturers or importers to the users of chemicals on potentia lhazards and on the safety precautions to be taken.

For record of disposal of waste chemical, l would relate this requirement with the Singapore Environmental Public Health (Toxic Industrial Waste) Regulations, Register 6,where it imposed the legal requirement of waste generators to keep a register as stipulated below:

Generator to keep register

6.—(1)  Every generator shall keep a register which shall contain the following particulars in respect of toxic industrial waste:

(a)the type and quantity generated;

(b)the manner of disposal;

c)the date and the quantity supplied or sold to a «toxic «industrial «waste collector;

(d)the name and address of the «toxic «industrial «waste collector; and

(e)the quantity held in stock.

2)  The register shall be kept up to date on a weekly basis unless otherwise specified by the Director-General and shall be kept for such period of time as the Director-General may direct.

As for record of use of chemical during product development, i would assume the safety datasheet of a particular chemical was review to gain a better understanding of the chemicals HSE risks and exposure to the end user.

Product Stewardship Action Plan

 

Recommend Actions To Be Taken To Conform To Product Stewardship Requirements

Product Stewardship is part of the Responsible Care Program bearing the document #GPCA-RC-C03. The code includes technical processes called Management Practices. The Management Practices provide specific technical requirements and guidance for Companies to fulfil their responsibilities in terms of Responsible Care and can also be used as a self-assessment tool

Obtain Relevant Codes

The purpose of the Product Stewardship Code is to make health, safety and environmental protection an integral part of designing, manufacturing, marketing, distributing, using, recycling and disposing of our products.

The Code provides guidance as well as a means to measure continuous improvement in the practice of product stewardship. The scope of the Code covers all stages of a product’s life. Successful implementation is a shared responsibility where everyone involved with the product has responsibilities to address society’s interest in a healthy environment and in products that can be used safely.

All employers are responsible for providing a safe workplace, and all who use and handle products must follow safe and environmentally sound practices.

The Code recognizes that each company must exercise independent judgment and discretion to successfully apply the Code to its products, customers and business.

This Code is composed of Management Practices as indicated in Table 1 – Product Stewardship Management Practices. Individually, each Practice describes an activity or approach to implementing the requirements of this Code

The implementation of Product Stewardship Code will help in fulfilling the requirements of the Responsible Care management system specification RC 14001. Notably, the implementation will help in closing gaps related to Product Stewardship requirements of the specification, particularly those requiring a system to facilitate the flow of hazard information to all elements of the value chain.

Obtain Top Management Commitment

The actions to be taken to conform to product stewardship requirements specifically ;obtain top management commitment are to get the buy in, commitment and support from all operations and organization levels and it requires a commitment for continuous improvement

Effective commitment from senior management, success in achieving excellence in accordance with the principles of Product Stewardship will not occur. Moreover, the program will lack credibility in the eyes of employees, our shareholders, customers and the public

Product Stewardship is an ongoing process that starts with an effective commitment from senior management (business direction). Through planning the development of the management systems, an organization would be able to implement & execute Product Stewardship effectively through the product entire lifecycle

The senior management develop the inventory of all HSE risks related to the properties, the production, distribution storage and use of chemicals followed by setting realistic and attainable goals for improvement of performance in relation to Product Stewardship and to measure (monitoring) actual performance against these goals.

Senior management must also ensure that there is an ongoing audit process to ensure that Product Stewardship systems are maintained and regularly reviewed (review) in a manner consistent with these principles. And any corrective and preventive actions that may arise should be taken if necessary.

Product Stewardship Principle

Products and/or services of the organization 

Background

Company XXX is a global manufacturer of polymeric medical grade components and systems for injectable drug delivery, including stoppers and seals for vials, and closures for the healthcare industry.

In view of Company XXX product manufacturing requirements, substantial amount of flammables and hazardous substances were employed in Company XXX operations where this emergency response plan is developed to mitigate the consequences and severity of the foreseeable emergency situations applicable to Company XXX  

Identification of relevant principle of product stewardship in accordance with Company XXX Organizational Procedures

The International Council of Chemical Associations define Product Stewardship as the practice of making health, safety and environmental protection an integral part of the life cycle of chemicals

It is an integral component of the global chemical industry’s Responsible Care® initiative and includes evaluations of risks and the development of actions to protect human health and the environment commensurate with those risks

Product stewardship is a shared responsibility between chemical producers, their suppliers and their customers. It requires the development of close working relationships with suppliers, customers, and others in relevant value chains

The close relationships enabled these parties to share information up and down the value chain to ensure that chemicals are used and managed safely throughout their life-cycle. 

And by doing so, they will also help companies and their partners meet the increasing demand for safe and environmentally-sustainable uses of chemicals.

The benefits of Product stewardship are; it can provides the platform for companies to identify risks at an early stage and manage those risks along the value chain, thereby enabling adequate protection of human health and the environment.  This can result in increased customer loyalty as well as expand the positive impact of product stewardship down the value chain.

Evaluation and avoidance of risk reduces the potential for harm and potential liabilities, making product stewardship a “value added” business proposition

The relevant principles of product stewardship applicable to Company XXX include:

• Responsible and pro-active management of the environmental ,health and safety aspects of products throughout their entire life cycle;
• Compare and contrast relations with sustainable development, and corporate social responsibility;
• Life-cycle considerations for products;
• An integrated business process involving all, not just a team of specialists;
• Systematic management of risk at the earliest opportunity in an alert, pro-active, interested and open fashion;
• A commitment to continually improve EHS performance of its operations;
• Open communications with interested parties;
• A means of competitive advantage;
• Strategic differentiation, leading to enhanced reputation with the authorities, customers, employers and the community at large;
• Minimize product liability and likelihood of severe adverse issues or publicity

However, in this post, i will briefly explained the principles associated with responsible and pro-active management of the environmental ,health and safety aspects of products throughout their entire life cycle and a commitment to continually improve EHS performance of its operations

Responsible and pro-active management of the environmental, health and safety aspects of products throughout their entire life cycle

This principle require the top management commitment in the reduction of the environmental, health and safety impacts of products throughout their entire life cycle, which would requires a thorough life cycle assessment from manufacture of parts and products to transport, use by customers (e.g. reduced power consumption) and final disposal.

A system has to be established to clarify the environmental, health and safety impact of products throughout their life cycles. This include tracking the total life cycle costs such as the costs of purchasing, transporting, storing, treating and disposing of materials, the loss of man hours and loss workdays due to recordable injury recorded as well as the compensation to employees for their occupational diseases arising from work and the insurance premiums paid by the organizations under the Work Injury Compensation

Collection of information relating to number of occupational diseases as well as the number of recordable injuries rate reported in the manufacturing site as well as the CO2 emissions and energy and resource consumption at each stage of the life cycle

With the availability of these information, it would enables Company XXX to identify products and stages with high environmental, health and safety impacts, clarify improvement priorities and prepare the HSE goals, objectives and targets. And this would in turn assist Company XXX  to monitor the environmental, health and safety impact of all its products.

A commitment to continually improve EHS performance of its operations

This principle would require the top management leadership and accountability to ensure it’s business units commitment and involvements to continually improve EHS performance of it’s operations which include:

• Management demonstrates that EHS issues rank amongst the highest priorities and maintains a commitment to continuous improvement.
• Business units to defines its Product Stewardship plan with appropriate targets and performance measures which are reviewed at least annually to maintain continuous improvement. Performance measures are broken down to annual employee target setting.
• Establishment of appropriate systems and procedures to manage EHS risks throughout the product life cycle, collecting information on the product's EHS hazards, assessment of employee and Customer EHS exposure
• Provision of training to employees and customers where the training scope may include the job function, with the objective of safe development, manufacture. storage, handling, transport, use and disposal of products.
• Communicate openly and honestly with employees and the public and be anticipative and responsive to their concerns about the potential hazards and impacts of products.
• Enforce the application of the Product Stewardship principles to all organization activities and to comply with all local EHS legislation and participate proactively in the development of local laws and regulations in all countries in which the Company has business activities

Product Stewardship Good Practices

Good practices related to product stewardship that have the environmental impact of the entire product life cycle –from raw material; use, manufacturing and production processes, product use and disposal 

Identification of good practices that requires conformance to product stewardship requirements

The good practices that requires conformance to product stewardship requirements for recognize and respond to community concerns about chemicals and chemical related operations would be the development of the manufacturing site specific pollution prevention program which shall include:

1. Written policy which demonstrates senior management clear commitment, communications, and provision of resources, for ongoing efforts to reduce environmental releases to the air, water, and land and in the generation of wastes.
2. Collecting and collation of quantitative inventory of wastes generated and hazardous releases to the air, water, and land, measured or estimated at the point of generation or release.
3. Evaluation, sufficient to assist in establishing reduction priorities, of the potential impact of releases on the environment and the health and safety of employees and the public.
4. Education of, and dialogue with, employees and members of the public about the inventory, impact evaluation, and risks to the community.
5. Establishment of priorities, HSE goals and plans for waste and hazardous release reduction, taking into  account both community concerns and the potential health, safety, and environmental impacts
6. Ongoing efforts in reducing wastes and releases, giving preference first to source  reduction, followed by recycle/reuse, and lastly to treatment. 
7. Measurement and tracking of progress in reducing the generation of wastes and in reducing releases to the air, water, and land, by updating the quantitative inventory at least annually.
8. Organize personal or face to face ongoing dialogue with employees and members of the public regarding waste and release information, progress in achieving reductions, and future plans. And emphasized by listening to others and discussing their concerns and ideas.
9. Inclusion of waste and release prevention objectives in research and in design of new or modified facilities, processes, and products.
10. Periodic evaluation of waste management practices associated with operations and equipment taking into account community concerns and health, safety, and environmental impacts and implementation of ongoing improvements.
11.  Implementation of a process for selecting, retaining, and reviewing contractors taking 
     into account waste management practices that protect the environment and the health and  safety of employees and the public.
12. Implementation of engineering and operating controls to improve prevention of and early detection of releases that may contaminate groundwater.

Sharing of past best practices for addressing operating and waste management  issues with others with the objective to help them resolve identified problems taking into account community concerns and health, safety, and environmental impacts.

The good practices that requires conformance to product stewardship requirements for making EHS considerations in planning for all existing and new products and processes

To integrate EHS considerations into the process and during the product development stage as product stewardship encompasses the assessment of the health, safety (excluding patient safety which is assessed separately), and environmental risks created during all stages of the product’s life cycle and in particular at the key decision stages in R&D. Similarly, product stewardship can also be apply to contract manufacturers and key suppliers

Environment, health and safety play an important role in the commercialising products by integrating environment, health and safety planning into decision-making on manufacturing processes, packaging design and product labelling, we help differentiate our products and protect and extend product life cycles.

And by fully embracing EHS principles, the sales organisation can minimise the cost of motor vehicle accidents and maximise the productivity of sales and distribution staff while optimising their environmental efficiency

Integrating EHS considerations helps an organization to achieve legal compliance with the EHS regulations in the country in which it operates. It can also continuously improve the organization’s performance particularly in the areas of accident and occupational illness prevention, waste minimisation and emissions reductions

HCP Program

OBJECTIVE

To provide guidelines to minimize the risks associated with workplace noise exposure to employees and to prevent noise induced hearing loss (NIHL). The company is committed to provide employees with a safe and healthful working environment. This is optimally accomplished by incorporating feasible safeguards into facilities and equipment designs. When effective engineering controls are not feasible, or when they are being initiated, administrative controls and/or personal protective equipment will be utilized to prevent employee exposure to noise over regulated or recommended levels.

SCOPE

Applicable to activities carried out within the company premise.  
 

RESPONSIBILITY
 

Management

The management shall:

-Ensure that noise control measures are in place such that no employees are exposed to excessive noise.

-Where 50 or more persons employed are exposed or likely to be exposed to excessive noise, a competent person  (Noise Control Officer) should be appointed to advise the management on the proper noise control measures.

-Ensure that the individuals who advise on noise control are suitably qualified, whether in-house personnel or service provider.

-Allocate appropriate resources and, as far as it is reasonably practicable, implement the noise control plan put up by  the competent person.

-Ensure that the noise control plan be reviewed at least once every three years or until such time when the noise is reduced to an acceptable level and the noise hazard is eliminated.

-Consider the noise emission levels during the selection and procurement of new machines since the selection of quieter machines at the initial stage can bring about cost savings from the need to introduce noise control measures after initial installation.

-Appoint a Hearing Conservation Program (HCP) Administrator to take charge of the HCP. 

The HCP administrator should be an individual who has keen interest in the company’s HCP. He / She should possess good communication skills and spend time at the production floor to interact with employees to discuss the noise problems and associated prevention or solutions. 

HCP Administrator

The HCP administrator should coordinate all aspects of the program and possess knowledge on:

-individual elements of HCP

-relevant provisions of the Workplace Safety and Health (WSH) Act, the Workplace Safety and Health (Noise) Regulations, and the WSH (Risk Management) Regulations,

-effects of noise on hearing, and

-purpose of hearing protectors and audiometric examinations 

The EHS Officer / Manager shall be the HCP Administrator. He / She shall:

-coordinate the HCP,

-monitor its progress,

-assess its performance,

-evaluate its effectiveness,

-review the HCP at regular intervals, 

-ensure that the set objectives are met,

-arrange meetings or discussions to promote collaboration of effort between management and team members, and-foster exchange of information between management and team members on the progress of the program

 

Competent person for noise monitoring:

A competent person is an individual who is trained to conduct proper noise monitoring. The person should work with the HCP administrator to ensure that noise monitoring is conducted properly. The tasks of a competent person include:

-Identifying work areas with excessive noise i.e. areas where employees are exposed or likely to be exposed to noise  levels at or above 85 dB(A).

-Identifying individual noise sources (e.g. equipment, machines, processes, operations and work activities) which  contribute to the excessive noise in the work areas.

-Monitoring or assessing the noise exposure levels of individual persons working in the work areas identified to have excessive noise. Determine whether the noise exposure levels are excessive, i.e., at or above an equivalent sound  pressure level of 85 dB(A) over an eight-hour period per day.

-Conducting noise monitoring or measurements at regular intervals (at least once every three years) or whenever there is any change in equipment, machinery, processes, operations, controls or other conditions, which may result in excessive noise generation or emission.

Ensuring  that the instruments used for noise monitoring are calibrated at required intervals. The accuracy of the instruments should be verified with an acoustic calibrator immediately before and after every measurement.  In addition, the instrument used should be sent to the manufacturer or its authorized agents for servicing and maintenance at intervals recommended by the manufacturer.

Ensuring  that noise measurements performed are representative of employee’s normal daily exposure to noise. To obtain representative results, the following should be considered:

-ensure adequate sampling of all work processes,

-ensure adequate duration of sampling, and

-discuss with employees to have a better understanding of the work environment  and processes monitored to obtain a more representative measurement.

-Ensure the appropriate selection of parameters, such as weighting network, meter’s response, exchange rate, criterion levels and threshold levels for accurate noise measurements. Normally an ‘A’ weighting network is used to measure the average noise levels while a ‘C’ weighting network is used to measure peak and impact / impulse noise. 

The following points should be noted during measurement:

.Measure at a suitable distance from the noise source. The sound measuring instrument should be held at arm’s length or using a remote microphone to avoid reflections from the body.

.Keep away from reflecting surfaces.

.Ensure that there are no obstacles between the noise source and the instrument.

.Check background noise level and make corrections if necessary.

.Use a wind shield to protect the microphone.

-Prepare a Noise Monitoring Report as described in the WSH (Noise) Regulations.

-Perform a noise mapping of work areas with excessive noise, including a contour of 85 dB(A) around the noise source(s) on the noise map.

-Present and explain the results of noise monitoring in a clear and understandable format to the management and employees. Ensure that results of the noise monitoring are communicated to all persons exposed to excessive noise not later than 14 days after preparation of the report.

-Assist management in implementing a job rotation schedule for the exposed employees if engineering noise controls are not practicable.

-Assist management in implementing a maintenance program for equipment and machinery to minimise noise generation from friction, wear and tear, or unbalanced parts of machines.

-Assist management in implementing a HCP which includes regular noise monitoring, hearing protection and health education of persons exposed to excessive noise.

 

Competent person for noise control:

A noise control officer is an individual who is adequately trained and knowledgeable on the details of noise control to provide the management with sound advice on the proper noise control measures. He/ She should work with the HCP administrator and the employees to ensure that the proposed noise control measures are implemented. The tasks of a noise control officer include:

-Identifying all possible noise sources.

-Evaluating specific machinery or noise source for noise control, and determining the most practical and effective  methods of reducing the noise to meet the desired criteria.

-Involving the machine operators or production people on the selection of the noise control measures which may interfere with their work; communicate with them on the proper use of the noise control devices to ensure that the controls are kept in good condition.

.Developing a comprehensive noise control plan with recommendations on engineering noise controls where practicable. A sample template of the noise control plan is in Appendix C.

-Working closely with the management when putting up the noise control plan, especially in recommending priorities and setting targets for noise control.

-Assisting the management in implementing the noise control plan and evaluating the effectiveness of noise control measures.

-Reviewing and revising the noise control plan at least once every three years or whenever there is a significant change in the work processes or machinery

RA Key Elements

Risk assessment is the scientific process of collecting and analyzing scientific data to describe the characteristic of risk which can take up many forms such as physical hazard, mechanical hazard, chemical hazards and biological hazards etc.

Every workplace should conduct risk assessments for all routine and non-routine operations carried out under various environmental situations, e.g., weather and soil conditions. Routine operations include activities such as preparatory and troubleshooting work activities. Non-routine operations include commissioning, repair and maintenance of plants

There are many risk assessment methods available in the industry and the choice of method depends very much on the purpose and scope of the available information or data used in an assessment as well as what we want to achieve at the end of  a risk assessment study

No matter which methods of risk assessment that you use, all methods should comprise the 3 basic steps of ; Hazard Identification, Risk Evaluation and Risk Control..

Hazard Identification is the process of identifying hazards in order to plan for, avoid, or mitigate their impacts and for decision making purposes.  Hazard identification is an important step in risk assessment and risk management

Hazard identification builds the foundation on which subsequent quantitative frequency and/or consequence estimates are made. We may have considered chemical, physical, mechanical and biological properties can present a hazard during a fault or failure conditions. But it is not always possible to be sure that all situations have been taken into consideration.

The simplest systematic approach to identify hazard is the use of checklist. Checklists are lists of known hazards or hazard causes that have been derived from past experience. The past experience could be previous risk assessments of similar systems or operations, or from actual incidents that have occurred in the past. This technique involves the systematic use of an appropriate checklist and the consideration of each item on the checklist for possible applicability to a particular system.

Checklists should always be validated for applicability prior to use.

Advantages of using checklist to identify hazard They can be used by non-system experts. They capture a wide range of previous knowledge and experience. They ensure that common and more obvious problems are not overlooked. Disadvantages of using checklist to identify hazard They are of limited use when dealing with novel systems. They can inhibit imagination in the hazards identification process. They would miss hazards that have not been previously seen. Consequence Analysis Consequence Analysis is the process of examining the possible effects of a planned activity, for example the possible risks to the environment that may be caused by building work Consequence analysis involves 4 basic activities which include: Characterizing the source of the release of material or energy associated with the hazard being analyzed Measuring through costly experiments or estimating using models and correlations the transport of the material and/or the propagation of the energy in the environment to a target of interest Identifying the effects of the propagation of the energy or material on the target of interest Quantifying the health, safety ,environmental, or economic impacts on the target of interest Risk Analysis Risk Analysis is a component of risk management, it consists of (1) Identification of possible negative external and internal conditions, events, or situations, (2) Determination of cause-and-effect (causal) relationships between probable happenings, their magnitude, and likely outcomes, (3) Evaluation of various outcomes under different assumptions, and under different probabilities that each outcome will take place, (4) Application of qualitative and quantitative techniques to reduce uncertainty of the outcomes and associated costs, liabilities, or losses. Successful QRA provide data and information that allow us to increase our wisdom and understanding of the risk of a particular activity. To interpret the QRA results would require us to review the analysis objectives For example if our objective is to identify the most important contributors to potential accidents, then the results may be completely unsuitable for presentation to zoning commission interested in the total risk of a toxic material release. Hence it is important and essential that QRA be interpreted only in the context of the study objective. Four essential area largely determine our success in capitalizing on high quality QRA results and they are namely; Presenting the results in perspective Recognizing the factors that influence perceptions of the meaning of the results Credibly communicating risk information in the public arena Avoiding common pitfalls in using the results for making the right decision Limitation in Risk Assessment When using the QRA results for decision making purposes or when chartering a QRA Study, we must recognize and respect the limitation in risk assessment due to the fact that quantitative risk analysis is subject to several theoretical limitation lists.

Completeness	There can never be a guarantee that all accident situations, causes, and effects have been considered
Model Validity	Probabilistic failure models cannot be verified. Physical phenomena are observed in experiments and used in model correlations, but models are, at best, approximations of specific accident conditions
Accuracy/Uncertainty	The lack of specific data on component failure characteristics, chemical and physical properties and phenomena severely limit accuracy and can produce large uncertainties
Reproducibility	Various aspects of QRA are highly subjective-the results are very sensitive to the analysts assumptions. The same problem, using identical data and models, may generate widely varying answers when analyzed by different experts
Skill Unavailable	The accuracy and corresponding uncertainty of a risk estimate depend heavily upon the expertise and judgement of the analyst
Inscrutability	The inherent nature of QRA makes the results difficult to understand and use

WSH Audit Resources

The lead auditor need to to ensure the auditors  required for the audit are available on the day, and ensure that sufficient resources are made available for the audit to be undertaken which may include

Finance resources for development, implement, manage and improve audit activities. 

Audit programme resources such as the use of external auditor due to difficulties involved with auditing areas where operational responsibilities or chain of command cause independence issues during an internal audit

Audit techniques

Audit programme resources such as the use of audit technique guide may be require during auditing with the objective to provide information to enable auditors to effectively audit issues pertaining to Workplace Safety and Health by providing the background information, Identify frequent and/or unique issues, provide examination techniques and Supply applicable law

Auditor

Audit programme resources such as the verification of the audit risk by external professional body due to the possibility that the auditors' findings, conclusions, recommendations, or assurance may be improper or incomplete, as a result of factors such as evidence that is not sufficient and/or appropriate, an inadequate audit process, or intentional omissions or misleading information due to misrepresentation or fraud. The assessment of audit risk involves both qualitative and quantitative considerations. Factors such as the time frames, complexity, or sensitivity of the work; size of the program in terms of dollar amounts and number of citizens served; adequacy of the audited entity's systems and processes to detect inconsistencies, significant errors, or fraud; and auditors' access to records, also impact audit risk

Subject matter experts

Audit programme resource such as engaging  the subject matter of experts (external professional body or local regulatory agency) for advice should the areas to be audited is a specialized one and none of the audit team members have prior knowledge nor experience

Instruments and equipment

Audit programme resource such as the engagement of MOM approved authorised examiners for the conduct of the inspection, testing and maintenance of the statutory equipment of steam boilers, pressure vessels and steam receiver as well as the lifting equipment, gears and accessories as well as the engagement of the original equipment manufacturer for reviewing quality of the equipment by assessing the conditions of the statutory equipment for consistency and their legal enforceability

Personal protective equipment for auditors

Audit programme resource such as the availability of the required PPE for Auditors site access during an audit and provision of PPE training to auditors on the use of the PPE

Managing WSH Audit

Managing the conduct of an audit in accordance with audit programme and plan which may include:-

• Plan and make effective use of audit resources
• Communicate with auditees or audit clients
• Organize and direct auditors activities
• Lead audit team to reach audit conclusion
• Ensure auditor code of conduct
• Prevent and resolve conflicts
• Prepare audit report
• Distribution of audit report

Tabulated below is the series of actions to be taken Vis-à-vis the audit process elements

Sample of the audit plan 

Conclusion

The audit conclusion is the outcome of the audit after considering the audit objectives and all findings. The conclusion generally also summarizes the extent of conformity of the auditee with the audit criteria