As the regulatory bodies continue to evolve and increase their requirements, fashions change; and now the requirement from the FDA/MHRA/HPRA commands that all companies must have a Disaster Recovery/Business Continuity Management plan in place. Now is the time to start your efforts to meeting the ISO:22301 Business Continuity Management accreditation for your business.
These are some of the questions you should be asking yourself;
What does this mean? What do I consider? Who can help me? How do I pick someone? What criteria should I look for? How much will it cost?
These are the things you will need to consider when choosing your service partner.
ISO:22301 International Standard for Business Continuity Management (BCM)
ISO:22301 and what is it?
The ISO:22301 is the world’s first international standard for Business Continuity Management to aid organisations to prepare and ensure their businesses can continue when facing external threats such as an information security breach or any form of natural disaster, such as flooding, fire or earthquake for example. The interruption of service provision, displacement or harm to personnel that disrupts the supply chain or causes damage to the company property or inventory will ultimately hit the company’s revenues and profits.
By adopting the BCM system, it will prepare your organisation and display to the regulatory authorities that your business is resilient, which in turn provides comfort to clients and stakeholders of a continuous operation and service, even if these events do occur. Receiving the ISO:22301 certification allows your business to demonstrate that your organisation management plan has been developed to determine your ability to respond to any incident that threatens the business-critical operations.
- Requirements of the ISO:22301 standard is applicable to all organisations of all sizes and industries
- Provides focus on assessing all risks and opportunities to visualise threats and provide a plan of action to maintain Business Continuity
- Specifies that an organisation has planned, established, ready to implement, operate, monitor, review, maintain and continually improve a documented management system to protect against any disruptive occurrence as and when they arise.
With this information to hand one of the requirements will be to look for a partner who you can work with to minimise this risk.
What you should look for in a Partner:
- Experience & Reliability
- Quality & Compliance
- Geographical Coverage (for multiple sites)
- Experience & Reliability
There is a plethora of outsourced capabilities in the market to handle the products you have on store currently, and varying positives and negatives of how these will all meet your requirements to reach the ISO:22301 standard.
Look for experience within the business. Do they have the knowledge on how to handle your samples in this environment? At a time that will be stressful, dealing with a disruptive incident in your business, you need experience and a plan that has been tried and tested on many occasions. Does the proposed provider have a plan on how to handle this type of incident? Have they evidence of auditing this process internally to confirm it both works and works for you? Are they adaptable to change to meet your own specific requirements? Can they help with the transportation planning needed? A good partner, will have a robust service, planned to the finest detail with the ability and staff to react at any time day or night.
Making sure that the volume of product you are looking to move can be managed within one site to reduce risk of multiple site planning. Having all the correct ICH and custom conditions your products may need to be stored in is imperative.
Your proposed partner should be able to meet all your requirements and needs. Your partners staff should be fully trained with full training records to hand for inspection. Their SOP’s should be detailed, signed off and an audit trail on internal processes to meet this immediate requirement for a “all hands-on deck” approach to accepting product with limited advanced notice.
Transporting products at short notice will also require careful planning and therefore, your partner should be able to work with you to help find a reliable logistics group, able to meet the condition requirements at a moment’s notice.
- Quality & Compliance
Your partner should be well versed and highly trained in all requirements needed for Quality & Compliance.
The highest standard of Quality Management System should be in place and evidence should be provided through an audit, to prove its robustness and compliance to meet your own exacting standards. The Quality management System must include documentation that covers the processes, policies and procedures that are followed consistently throughout the business allowing full document trail should also be available as evidence. It should be at the very core of all its activities and its ability to meet regulatory agency requirements. Outsourcing products for storage should be the very basis of this business partnership to give you the security and satisfaction that your products will be handled, monitored and secured in the appropriate manner.
The equipment your products will be stored in should be of the highest quality. The monitoring systems, validation and servicing documentation should be accessible to your auditors upon request.
A full back up system should also be in place for any disruption your partners should experience at any time. An uninterrupted power supply should be standard within any service provision and IT network failures accounted for with the ability to maintain performance whilst archiving data for reference.
- Geographical Coverage
Many companies operate from multiple facilities either within the same territory or globally. Partnership with a provider who has UK, European and US coverage is beneficial to allow a global approach to all Business Continuity Management standards. A service provider should have global standards through their own Quality & Compliance, meaning that wherever the site, whatever the product, the process will be managed, monitored and executed to the same high standards, giving you, the client complete peace of mind.
Companies in general are looking to reduce the number of providers used for the same or similar activities, finding a global partner will see this goal achieved, but also will allow some significant cost savings.
Business Continuity Management is partially an insurance policy, therefore, whilst you may find a provider who will offer this service for free, be warned that charges will be added upon execution of the activities. A good provider will charge a minimal monthly amount to keep space provision onsite in case of a disruptive incident. Staff should be kept on an on-call rota and assigned tasks and duties in readiness for any such eventuality. A partner who is up front with their costings, services and eventual charges is the type of partner most will and have chosen.
This list is not exhaustive, but a general guide to areas where an outsourced partner can add significant value into the goal of reaching the ISO:22301 accreditation.
Source BioScience’s Stability Storage Solutions Group have been offering an outsourced stability storage service for 30+ years from sites in Europe, UK & US. Using their world leading 21 CFR Part 11 compliant equipment backed by their own dedicated service & validation teams, Source BioScience can offer a first-class service for all your Business Continuity Management needs to achieve ISO:22301 accreditation for a low fee whilst consistently adhering to current Good manufacturing Practices (GMP) and also ISO 9001:2015 Quality standards. Whether or not the requirement to meet this standard has been raised within your business through your regulatory inspection, our experience shows, that clients are overlooking this service and accreditation. Don’t leave this to the last minute, contact us now to start your journey and provide the security you need for your supply chain. With the world’s climate changing and the images we have seen across Australia, the US, Europe and the UK we can take a lot of your stresses away.
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