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0         Preface

Bureau Registrar Services of Millennium (BRSM), responds to an accreditation – recognition platform / system of higher purpose authoritatively carrying a legal instrument to protect communities and consumers throughout its worldwide jurisdictions. This accreditation responds to a trilogy of highest authorities (IAF). To this effect, impartiality needs to respond through policies that commence in values, mission and vision for a legally binding purpose. In addition, BRSM addresses the requirements of ISO/IEC 17021-# in adherence to local accreditation programs.

Regarding our responsibility overseas, we developed a scheme based on a PDCA system integrating with guidelines issues by NIOSH, CDC, WHO and local regulatory and statuaries for epidemics including COVID-19.

 

 

 

1         Scope

This Scheme specifies a framework to identify, develop, Implement and improve when a company:

  1. a) is active during Epidemics and/or
  2. b) is active during Pandemics

All the requirements of this scheme are generic and are intended to be applicable to any company, regardless of its type or size, or the products and services it provides, while we do not except same system for all companies that are using this scheme.

Note: Pandemic and Epidemic are temporary so we used term “SITUATION” that can mention to both of these temporary conditions.

2         Normative references

This scheme is referring to guidelines from the highest-level authorities regarding the situations that this scheme is to provides a framework for the company’s include but not limited to the following:

www.cdc.gov (Centers for Disease Control and Prevention)

www.who.int (World Health Organization)

3         Business Environment

The company shall identify and manage external and internal issues and expectations of interested parties that are relevant to its purpose and its strategic direction regarding the safety and Hygiene System (SHS) of all activities during the situation.

Note: without considering external and internal factors some aspects may be missed to handle during emergencies.

Note: company shall ensure working under the situation is allowed by local authorities.

Note: company must prepare a document including but not limited to: Scope, mission, vision, Strategic Plan, activities, interested parties and working hours during the situation.

4         System Requirements

Company shall establish, implement, maintain and continually improve a SHS, including the activities needed and their interactions, in accordance with the requirements of this scheme, those requirements are included but not limited to:

  1. A manual describing how company implemented this Scheme
  2. Operation process chart and/or Data flow diagram and/or flow process charts or any means that clarifies activities related to the situation;
  3. Documents that are mentioned in this scheme

5         Preliminaries

5.1        Leadership

Top management shall demonstrate leadership and commitment with respect to the SHS by taking responsibility for the effectiveness of the system and ensuring that the policy and objectives are established for the SHS and are compatible with the environment and strategic direction of the company;

Note: Top manager (that legally is director of the company) is responsible for this system, in case of using representative(s), authority can be delegated but not the responsibility.

5.2        SHS Team

Top Manager shall allocate of disciplined and competent team to ensure integration and comprehensiveness of system. All documents within system shall be prepared by this team

5.3        Policy

Top manager shall prepare a policy of its business regarding the situation it shall be include but not limited to:

  1. Commitment to mitigate the risk of disease transmission
  2. Commitment to continually update the requirements (refer to paragraph 4 & 7)
  3. Commitment to improvement of the SHS
  4. Commitment to supply any resources needed to mitigate the risk of disease transmission regarding the mission and activities of company (refer to paragraph 4)
  5. This Policy shall be communicated to internal and external interested parties
  6. Describing channels for feedbacks by the interested parties and accountability to take proper action against them (refer to paragraph 8)

Note: Policy shall be available for interested parties

5.4        Objectives

The company shall establish short term objectives relevant with SHS and activities

needed for the system. These objectives are a mean to fill the gaps or improvements.

Note: requirements shall be met, in other word, company cannot be certified without meeting all requirements.

Objective shall be in line with SHS.

 

6         Planning and support:

6.1        Risk Management

To ensure system can achieve its intended result, prevent, or reduce, undesired effects and achieve improvement, company shall prepare a risk document regarding its environment and activities. The risk shall be based on ISO 31000 but the way of application can be selected based on nature of company.

Note: Risk methods are described in ISO 31010 that is available on www.ISO.org

Note: For the company that are providing feed, food or human health products, performing a secondary risk management regarding life cycle of products and service are necessary too, HACCP for food and feed companies and FMEA for drug, medicine and medical devices.

6.2        Document and record control

Company shall have a documented procedure to:

  1. Gather all data necessary from local authorities and international databases that this scheme is intended to and all are update

Note: all databases shall review at least weekly, this review shall be done by a competent person

  1. Make it available for the applicable divisions and executers
  2. Ensure that related records and outcomes are effective
  3. Records and documents are available, retrievable and accessible for determined level of people.

Note: all procedures can be in the manual, there is no mandate to format or method of documentation.

6.3         Work Environment

The company shall determine, provide and maintain the resources for the establishment,

management and maintenance of the work environment necessary to achieve conformity with the

requirements of the SHS.

NOTE A suitable environment can be a combination of human and physical factors such as:

  1. social (e. g. non- discriminatory, calm, non- confrontational)
  2. psychological (e. g. stress-reducing, burnout prevention, emotionally protective)
  3. physical (e. g. temperature, heat, humidity, light, air flow, hygiene, noise)

These factors can differ substantially depending on the products and services provided.

6.4        HR

The company shall ensure that people necessary to operate and maintain an effective SHS are

Competent Where the assistance of external experts is used for the development, implementation, operation or assessment of the SHS, evidence of agreement or contracts defining the competency, responsibility and authority of external experts shall be retained as records.

6.5        Machines, tools and equipment

The company shall provide the resources for the determination, establishment and maintenance of

the infrastructure necessary to achieve conformity with the requirements of the SHS.

NOTE: Infrastructure can include:

  1. Land, vessels, buildings and associated utilities;
  2. Equipment, including hardware and software;
  3. Transportation;
  4. Information and communication technology.
  5. Measurement device, tools and equipment

7         Operation and control

With all necessary from clause 4-7, company shall prepare at least these documents:

  1. Pre-start
  2. Start
  3. After-finish

Note: gathering information and detecting system requirements in the critical step to develop an effective system.

Note: This scheme does not mean to overcharge the company but develop an agile and effective system to mitigate risk of disease transmission that shall cause to outbreak prevention

Note: If company already has a system, it can use same formats considering new requirements, for example, in food sector, if company already has FSMS system, they can review and use PRP/OPRP checklist.

Company shall keep records to show effectiveness of performance of SHS.

7.1        Pre-start

  1. Inspection work instruction, forms, logs and checklist for people, work environment and infrastructure
  2. Pest control work instruction, forms, logs and checklist
  3. Cleaning and disinfecting work instruction, forms, logs and checklist

7.2        Start

  1. Work Instruction of activities for people, work environment and infrastructure
  2. Inspection work instruction, forms, logs and checklist
  3. Cleaning and disinfecting work instruction, forms, logs and checklist

7.3        After-work

  1. After work instructions
  2. Inspection forms, logs and checklist
  3. Pest control work instruction, forms, logs and checklist
  4. Cleaning and disinfecting work instruction, forms, logs and checklist

Note: people shall be aware of how to transport from home to work and vice versa.

7.4        Critical case preparedness

Company shall be prepared for critical cases that may be emergencies too. This critical case are listed but not limited to:

  1. Critical places
  2. Critical activities
  3. Critical People
  4. Detection of an infection regarding the situation
  5. Detection of a suspicious people

7.5        Scenario and mock

Company shall have a scenario for identified critical cases, this scenario(s) shall be effectively communicated to related people and divisions.

Mock practice is a powerful mean to ensure these scenarios

Control of failures (refer to 8.3) shall be done after each case of failures to:

  1. manage failure and
  2. Avoid repetition

Note: Communications, recall, withdrawals and reporting to authorities can be some activities to handle failures.

8         Monitoring and improvement

8.1        Monitoring and Analysis

The company shall document:

  1. What needs to be monitored and measured;
  2. The methods for monitoring, measurement, analysis and evaluation needed to ensure valid outcomes;
  3. Intervals the monitoring and measuring shall be performed, analyzed and evaluated.

8.2        Feedbacks

Company shall document feedbacks to correct or improve the system, these feedbacks shall include internal and external interested parties.

8.3        Corrective action

The company shall take action to eliminate the causes of failures in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the failures encountered.

  1. a) Reviewing failures (including negative feedbacks),
  2. b) Determining the causes of failures,
  3. c) Evaluating the need for action to ensure that failures do not recur,
  4. d) Determining and implementing action needed,
  5. f) Reviewing the effectiveness of the corrective/preventive action taken.

 

8.4        Improvement

The company shall continually improve the suitability, adequacy and effectiveness of the SHS.

Note: main input of this can be guidelines updates and feedbacks

 

 

 

Appendixes:

www.cdc.gov (Centers for Disease Control and Prevention)

www.who.int (World Health Organization)

COVID-19:

https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance

https://www.who.int/emergencies/diseases/novel-coronavirus-2019/advice-for-public

http://www.euro.who.int/en/health-topics/health-emergencies/coronavirus-covid-19/novel-coronavirus-2019-ncov-technical-guidance

Note: Local regulations and legislations precedence over international regulations and legislations