Blackmores ISO Consultancy Service: The creators of isology®

The world of ISO is often stumbled into as a result of being tasked with either Implementing or maintaining a Standard for a business. It is rarely a desired career path, and yet there are thousands of ISO professionals from all corners of the globe.

We’re continuing with our latest mini-series where we introduce members of our team, to explore how they fell into the world of ISO and discuss the common challenges they face while helping clients achieve ISO certification.  

In this episode we introduce Derek Hall, a Senior Isologist® and Sustainability Lead at Blackmores, to learn about his journey from spending 40 years in the printing industry to becoming an ISO Consultant, and what drives him to help clients on their ISO journey.  

You’ll learn

• What is Derek’s role at Blackmores?
• What does Derek enjoy outside of consultancy?
• What path did Derek take to become an ISO Consultant?
• What is the biggest challenge he’s faced when implementing ISO Standards?
• What is Derek’s biggest achievement?

Resources

• Isologyhub
• Climate Change Amendment Workshop

In this episode, we talk about:

[02:05] Episode Summary – We introduce Derek Hall, a Senior Isologist® here at Blackmores, to discuss his journey towards becoming an ISO consultant who specialises in ISO 9001, ISO 14001 and ISO 22716.  

[03:45] What is Derek’s role at Blackmores? Derek is a Senior Isologist® with Blackmores, supporting companies with maintaining systems, undertaking internal audits, and supporting with implementing new systems to gain certification utilising our Isology methodology.

His passion lies in the realm of sustainability, embedding it within the management systems of many of our clients regardless of any certification to any dedicated sustainability Standard.

Derek was worked with a number of sectors, including:-

• Media
• Printing
• Constructions
• Cosmetics
• Recycling
• Electrical
• Public Sector & NHS

Derek enjoys the learning aspect of working with new industries, and values the input from all personnel involved, from top management to those on the shop floor. He well and truly immerses himself within each company he works with to learn about their values and how ISO can best support their vision.

[08:30] What does Derek enjoy doing outside of consultancy?: Derek has a few varied hobbies, including oil painting born out of his other passion, photography. He often uses his own photos as subject matter for his paintings.

He also trains 4-5 times a week at his local karate club, which caters for all ages and skill sets. Derek has diligently worked his way up to black belt over the 17 years he’s been attending, and offers his skills to teach sessions.

He appreciates the respect that karate teaches, in addition to gaining more knowledge on other points of view. With such a varied class, there’s always something new to learn.

The Australian based club he attends is called GKR Karate.

[12:20] What was Derek’s path towards becoming an ISO Consultant?: Derek’s journey starts back in the 60’s, where he worked in commercial photography, taking pictures on the progress of various building works, and products for furniture stores.

He used to work with plate photography, which was a rather old school method even back then! This was coupled with more modern methods such as 35 millimeter film. He recalls witnessing the building of the Thames barrier, taking pictures to help monitor the amount of water coming through the barrier.

After that he moved onto work for a printing company in Barnet (Hertfordshire), which specialized in advertisements and signage for furniture stores. From the shop floor Derek worked his way up to becoming a printer operative.

This company evolved to include screen printing, which allowed for more versatile applications such as clothing or certain plastics.

After spending 3 and a half years there he moved on with a friend to start their own printing company in Watford, which continued until the 70’s.

In the 70’s Derek joined a much larger printing company based in Southgate London. Here he was involved in the printing of cinema posters for theatres, and musical groups. Derek remained there for 40 years, watching it evolve to larger scale printing for retail markets such as HMV Records and curry’s, in addition to bus advertisements.

During the 90’s, there was a larger push for quality Standards, their clients wanted more assurance that they were following established guidelines and could produce the quality they were after. So, Derek was tasked with Implementing BS 5750, ISO 9001’s precursor, and BS 7750, ISO 14001’s precursor.

The company then got involved in an eco management audit scheme called EMAS, which required the reporting of environmental impacts. It was similar to ISO 14001, but it’s regulatory reporting requirements more closely align with modern schemes such as ESOS.

They also introduced other schools of thinking such as Kaizen, for the purpose of continual improvement.

At this point, Derek became very involved with sustainability standards, and developed a concept called ‘The Tree of Sustainability’, which included 9 branches for improvement. This was introduced due to the fact that their industry by its current nature, wasn’t very sustainable. There was a lot that could be done to reduce their impact.

Through developing that project Derek got involved with the DTR project called ‘The Sigma Guidelines’, a backed scheme run by the BSI forum and The Accountability Institute. These guidelines outlined a 3-year project to identify what sustainability meant to them and how it could apply to their industry.

The result of their work on this project was then submitted to various awards, netting them a number of sustainability awards and The Accountability Institute Awards.

That company continued its operations until 2007, leading to Derek joining Blackmores first year of operation in 2008.

Derek is leading us down a similar sustainability path by encouraging us to become a signatory of the Terra Carta, an initiative including 100 different actions for nature, people and planet.

[26:40] What is Derek’s favourite aspect of being a Consultant? – Derek has a few, including:

Building relationships with clients – Many of Dereks clients have been working with him for over 10 years. He’s as much friends with them as he is a work colleague.

Flexible approach – Consultancy can be delivered in many different ways, allowing for hybrid working. This flexible approach also applies to the way we achieve internal targets, with each member of the team being given specific goals with the freedom to choose how they reach them. Everyone has their own way of working, and we encourage all members of the team to work how they like with the opportunity to learn from each other.

[28:35] What Standards does Derek specilaise in and why? Starting with:

• ISO 9001 Quality Management: A core foundation that many businesses start with when diving into the world of ISO Standards. Derek started with it’s predecessor, and has watched it develop over the years. He appreciates the value it can bring, especially to SME’s who are looking for a scalable model for success.
• ISO 14001 Environmental Management: Derek is a fan of sustainability in general, and encourages everyone to implement some of it’s requirements as part of any project.  
• ISO 22716 Good Manufacturing Practices for the Cosmetics Industry: A rather niche quality standard for the cosmetic industry, this Standards works well in collaboration with ISO 9001 for a more holistic approach.
• ISO 45001 Health and Safety Management: Derek picked up this Standard as a result of his work with the construction industry. It’s importance as a tool to prevent harm to humans cannot be understated.
• ESG: Derek has been working closely with his colleague, Ali Henshaw, to develop an ISO based framework to tackle ESG requirements. This includes inputs and requirements from guidance standards such as ISO 20400 (Sustainable Procurement) and ISO 26000 (Social Responsibility)
• ISO 22301 Business Continuity: A lot of organisations are looking to implement aspects of business continuity as a result of the ever-changing resilience landscape.

[32:20] The link between business continuity and climate change: We have seen client requirements evolve to include various elements of business continuity in response to the increasing threats of cyber incidents and climate change related issues.

This is reflected in the recently introduced Climate Change Amendment to many commonly implemented ISO Standards. This requirement ensures that businesses consider their impact on climate change in addition to, how and if they would be affected in turn. If you would like to learn more about this, listen to a previous episode or watch our Workshop playback.

[34:20] What is the biggest challenge Derek had faced during a project and how did he overcome it?: Derek took on the challenge of implementing ISO 22716, when he knew very little about the Standard and the cosmetics industry as a whole. Though there were a few stumbles on his first attempt, they managed to get certified without issue.

That same company then wanted his help to implement ISO 14001, which is a tough ask for the cosmetics industry. There are a lot of factors to consider, such as:

• What is their environmental impact?
• Where are you sourcing materials?
• Are the ingredients shipped from across the globe or sourced locally?
• Is there any animal testing involved?
• How sustainable was their supply chain?

There was a lot to get through, but it was a beneficial choice to get a full picture of their environmental cost.

Later, the company opted to implement ISO 9001 in addition to their existing Iso 22716 and ISO 14001 certifications. This fit nicely as both ISO 22716 and ISO 9001 are quality based Standards, they complemented each other and created an effective and holistic management system.

[27:20] What is Derek’s proudest achievement?  Derek received an MBE from the late Queen for services in the environment in 2005. This was earned through his sustainability work within the print industry.

For those not familiar, the Queens Award (now the King’s Award) is a prestigious award that requires 3 levels of review and vetting before winners can be announced. It includes checking evidence provided and the financials involved to verify if applicants have achieved what they say they have achieved.

Derek, along with his wife and daughters, were invited to the palace to meet the queen and receive his award.

If you’d like any assistance with implementing ISO standards, get in touch with us, we’d be happy to help!

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• Share the ISO Show on Twitter or Linkedin
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ISO 22716 sets out the framework for a quality management system for anyone involved in the manufacture of cosmetics and other healthcare related products. While this Standard’s focus is on the manufacture of cosmetics specifically, many of the requirements can apply to any manufacturing process, especially those that involve a risk of contamination.

This Standard sets out clear guidance to help you ensure you align with Good Manufacturing Practices (GMP), but how do you go about implementing it?

In our last episode of the ISO 22716 series, we bring back Derek Hall once again to share his experience with implementing ISO 22716 and offer some top tips to get you started.

You’ll learn

• What considerations do you need for every aspect of the manufacturing process?
• How you can apply ISO 22716’s principles to your own processes
• Derek’s experience with his clients

Resources

• isologyhub
• Blackmores ISO 22716 Implementation

In this episode, we talk about:

[01:10] If you want a recap on the Standard – Watch our first episode in the ISO 22716 series  

[01:50] Key considerations for Personnel: Establish an Organisational Chart (with clear references for the responsibility and authority of quality issues), use a Skills matrix to help determine where training gaps are, develop procedures and processes to control what people can and can’t do in certain locations.

[08:33] Key considerations for Premises: Manufacturers should consider how the building is designed and laid out, ensure that there is a good flow for materials, have effective filling and packaging areas, introduce efficient sanitation programs, what can you do to minimise mix-ups?

[10:45] Key considerations for Premises: Manufacturing areas should only be accessed by authorised personnel, you should have effective measures in place to prevent pests – this includes the exterior as well as the interior of your buildings! You might want to consider external contractors for pest control.

[13:05] Key considerations for Equipment:  Ensure all equipment is fit for purpose, efficient and has the ability to be cleaned thoroughly, make sure any calibrations are assessed and documented, equipment should be laid out in a way to ensure a flow of materials, make sure there is a clear segregation of manufacturing and storage areas.

[16:45] Key considerations for Raw Materials and Packaging Materials:  – Raw materials should be well stored and clearly labelled, source your materials from trusted and accredited suppliers, have a controlled and quality approved list of suppliers and vendors (Do these suppliers provide proof of quality? Set out your minimum requirements for quality and ensure suppliers fulfill these)

[19:15] Key considerations for Production:  All raw materials and manufacturing batches should be identified by a unique code for control and traceability, regular quality control inspections should take place, determine what methods are used to ensure that products meet customer expectations, samples should be taken during set stages of manufacturing to check for quality.

[21:20] Key considerations for Finished Products:  Finished products should not be stored on the floor (use pallets), do what you can to minimise contamination during storage, ensure all staff know how to store products correctly and what to do if there is contamination, have defined acceptance criteria for products, have clear labelling, any faulty products should be labelled as ‘quarantined’ or ‘rejected’ and moved to a designated area.

[24:48] Key considerations for Quality Control:  Ensure all raw materials, components, bulk product and packed products pass established quality tests, obtain Certificates of Analysis, have acceptance criteria forms – fill these out at all relevant stages.

[26:30] Any products out of specification should be investigated by authorised personnel, only those responsible for product quality can decide to destroy or reprocess products.

[27:25] Key considerations for Wastes:  Identifiy different types of waste, ensure these wastes are disposed of in a timely and sanitary manner, have processes in place for collection, transportation, storage and disposal of waste.

[28:48] Key considerations for Wastes:  Where necessary, allocate a code in line with the European Waste Catalogue, ensure that correct waste carriers licenses are received and maintained.   

[29:19] Key considerations for Subcontracting:   You can subcontract a  lot of aspects i.e. cleaning, pest control, packaging ect. Ensure that any subcontractors are reviewed and approved, have clearly defined written agreements in place that outline roles and responsibilities (this can be a contract or just strictly in writing)

[32:10] Key considerations for Deviations: Deviations can happen anywhere, have a regime in place to investigate complaints, in the case of serious deviations that could affect health and safety – ensure you have an effective recall process in place.

[33:25] Key considerations for Complaints and Recalls:  All complaints should be communicated to the plant, all complaints should be investigated and followed-up, if a recall needs to happen – ensure that appropriate steps are taken to recall and then take corrective action.  

[12:05] Key considerations for Change Control: Have a change management system in place to document any changes (and define if they are fixes, enhancements or major revisions), you need to establish who can: request, approve, develop, test and implement these changes.

[36:35] Key considerations for Internal Audits: Internal audits need to be carried out in regular intervals, a minimum of 1 a year (but we recommend more!), track findings and document any corrective actions taken in a Continual Improvement Log.

[38:17] Key considerations for Documentation: Documents are used through the whole process – ensure all documents used are approved, signed and dated by authorised personnel, key documents should be version controlled.

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• Share the ISO Show on Twitter or Linkedin
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ISO 22716 sets out the framework for a quality management system for anyone involved in the manufacture of cosmetics and other healthcare related products. While this Standard’s focus is on the manufacture of cosmetics specifically, many of the requirements can apply to any manufacturing process, especially those that involve a risk of contamination.

As discussed in last weeks’ episode, having ISO 22716 is essential if you are manufacturing or distributing within the EU. Besides being a legal requirement for certain regions, what other benefits can ISO 22716 offer?

Today, Mel is joined by Derek Hall, a Senior Consultant here at Blackmores, to explain some of the key internal and external benefits of ISO 22716 and how it can work in tandem with other ISO Standards.

You’ll learn

• The internal benefits of ISO 22716
• The external benefits of ISO 22716
• How can ISO 22716 work with other ISO Standards?

Resources

• isologyhub
• Blackmores ISO 22716 Implementation

In this episode, we talk about:

[00:50] Adoption of standards such as ISO 22716 are often key requirements of Stakeholders

[01:15] One general benefit of implementing ISO 22716 is the ability to win new business by virtue of displaying compliance to EU regulations.

[01:40] What are the internal benefits? Firstly, it ensures you’re legally compliant  

[02:10] ISO 22716 put controls in place that can reduce risk and hazards with product manufacture, storage and distribution.  

[02:35] There can be tangible cost savings – Derek highlights a few clients who have taken a step back to correct and improve their internal processes, which in turn resulted in cost savings. Compliance can also help to avoid any fines

[03:29] It can help to avoid products being wrongfully distributed – which can be a very costly mistake, both in time, money and reputation.

[04:20] ISO 22716 can integrate seamlessly with other ISO Standards such as ISO 9001 (Quality Management), ISO 14001 (Environmental Management) and ISO 45001 (Health and Safety Management). They are all based on a similar framework and are designed to work together  

[06:15] ISO Standards can act as a roadmap for managing a business – especially for micro businesses

[08:05] ISO Standards are all scalable and can apply to any size of business. So, if you were to acquire more sites, you can simply roll out your management system across the expanding business

[08:43] ISO 22716 is very clearly laid out and easy to follow

[09:30] What are the external benefits? It’s an internationally recognised Standard, and can be used for various marketing and tendering opportunities

[10:47] ISO 22716 is a mark of quality and displays a brands commitment to delivering quality products

[11:10] It promotes ethical behavior through your supply chain  

[11:50] It promotes regulatory credibility – Ensures your products meet regulatory requirements

[12:05] It gives assurance that your product ingredients also meet legal requirements

[12:40] Some ISO Standards can reduce insurance costs – This is something we’ll explore in future episodes!

We’d love to hear your views and comments about the ISO Show, here’s how:

• Share the ISO Show on Twitter or Linkedin
• Leave an honest review on iTunes or Soundcloud. Your ratings and reviews really help and we read each one.

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ISO 22716 sets out the framework for a quality management system for anyone involved in the manufacture of cosmetics and other healthcare related products. While this Standard’s focus is on the manufacture of cosmetics specifically, many of the requirements can apply to any manufacturing process, especially those that involve a risk of contamination.

On the surface, ISO 22716 may be considered a niche Standard, so why it is still so widely adopted?

Today, Mel is joined by Derek Hall, a Senior Consultant here at Blackmores, to discuss the key drivers behind ISO 22716, including legal EU requirements and other related regulations.

You’ll learn

• Why is ISO 22716 used as an industry Standard?
• What is ISO 22716’s relation to the Cosmetic Regulation (EC) No. 1223/2009?
• Who are these regulations applicable to?
• Other regulations and Standards applicable to cosmetics manaufacturing

Resources

• isologyhub
• Blackmores ISO 22716 Implementation

In this episode, we talk about:

[00:42] A brief summary of ISO 22716 – watch the last episode for a full summary

[01:25] Do you still need to comply with EU directives? Short answer – Yes, especially if you sub-contract parts of your manufacturing process / packaging or export product within the EU.

[02:00] Why was the Cosmetic Regulation (EC) No 1223 created? To streamline and modernize current legislation across Europe for Cosmetics (though this can also include hygiene products i.e. soaps, toothpaste, deodorants ect)

[03:30] What is the Cosmetic Regulation (EC) No 1223? This regulation establishes rules to be complied with by any cosmetic product made available on the market – to ensure a high-level of protection of human health

[04:21] ISO 22716 is the central pillar of the Cosmetic Regulation (EC) No 1223

[05:02] A bit of background to the EU adoption of ISO 22716 – On April 21^st 2011 – ISO 22716 officially became the Good Manufacturing Practices Standard for cosmetic product across Europe. This created a harmonised approach that ensured cosmetic products are safely manufactured, stored and shipped.   

[05:58] The whole regulation came into effect in July 2013. The laws for each nation had to follow this regulation – which included any relevant Standards or guidance affecting the cosmetic industry. This requirement also applies to any cosmetic manufacturers outside the EU that want to import into the EU.  

[07:36] Who are the regulations applicable to? Anyone involved in the cosmetic products chain (European and non-European). This includes raw materials producers, product assembly, distributors, exporters ect

[08:05] ISO 22716 provides guidance for most parts involved in cosmetic production i.e. production, control, storage and shipment. However, it does not cover: safety for personnel (this may fall more under ISO 45001), protection for the environment, is not appliable to research & development and not appliable to the distribution of finished product

[09:55] ISO 22716 is almost 20 years old – so environmental considerations weren’t as much at the forefront of product manufacturing as they are today. Any manufacturers should be doing what they can about their impact regardless of current regulations (new versions may add guidance around this, so keep up-to-date with regulatory changes)

[11:45] Other applicable standards include: The two part ISO 16128 Standard:

ISO 16128-1: Guidelines on technical definitions and criteria for natural and organic cosmetic ingredients and products

ISO 16128-2: Describes approaches to calculate natural, natural origin, organic and organic origin indexes that apply to the ingredient categories 

[13:58] COSMOS (standard Cosmetics Organic and Natural Standard) was created by many different International parties including BDIH (Germany), COSMEBIO & ECOCERT (France), ICEA (Italy), AISBL (Belgium) and Soil Association (UK). Its purpose is to define common requirements and definitions for organic and / or natural cosmetics.

[15:25] Standards are created collaboratively by technical committees made up of global experts of their respective fields – they take years to develop to establish best practice

[16:09] ISO 22716 has been approved by many regulatory bodies around the world, including the ICCR (The International Cooperation on Cosmetic Regulation), FDA (Food and Drug Administration), JCIA (The Japan Chemical Industry Association) and ASEAN Consultative Committee for Standards

[17:10] Through current regulations, there is increased responsibility in regards to: Ingredients toxicity, product labelling, more comprehensive product file and compulsory notification of new products introduced to the EU

[21:00] The current regulations have specific requirements for ingredient toxicity and product labelling

We’d love to hear your views and comments about the ISO Show, here’s how:

• Share the ISO Show on Twitter or Linkedin
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ISO 22716 sets out the framework for a quality management system for anyone involved in the manufacture of cosmetics and other healthcare related products. This is not only limited to production but also the control, storage, and transportation of products, including the purchase of raw materials, components and packaging material.

While this Standard’s focus is on the manufacture of cosmetics, many of the requirements can apply to any manufacturing process, especially those that involve a risk of contamination.

Today, Mel is joined by Derek Hall, a Senior Consultant here at Blackmores, to talk through the main structure of the Standard and how it can be applied.

You’ll learn

• What is ISO 22716?
• Who does ISO 22716 apply to?
• How is ISO 22716 structured?
• How ISO 22716 can be applied

Resources

• isologyhub
• Blackmores ISO 22716 Implementation
• The Checklist Manifesto

In this episode, we talk about:

[00:35] A description of ISO 22716 Good Manufacturing Practices – A supporting Standard for the manufacture of cosmetics

[01:20] Why are we talking about such a niche standard? It’s one of our most popular standards via website enquiry, so we’d like to share our knowledge 😊

[02:20] There is an EU directive pushing for the adoption of this Standard where applicable

[03:00] A more in-depth summary of ISO 22716 – Why it’s so important and why it was made

[04:01] What does ISO 22716 cover? Guidelines and practical advice on the management of the human, technical and administrative factors affecting product quality.

[04:58] A summary of the 17 clauses within ISO 22716

[07:55] What are the core elements of ISO 22716? Personnel, Premises and Equipment, Operations and Material Management, Quality Control and Cosmetics Quality Management System

[08:50] Personnel – Key considerations include: Restricted areas free from food and drink, visitor supervision, personnel authorisation, personnel uniforms (removal of rings, hair restraints, safety glasses, gloves ect)     

[11:25] Premises and Equipment: The layout of buildings and equipment placement need to be controlled, controls for sanitisation and cleaning, guidance for storage, proper access to materials and equipment.

[13:27] Premises: Pest control – should be very controlled to prevent contamination. This can be controlled via the building layout and cleaning controls. A pest control program should be created and followed. This extends to the exterior of your building too!  

[15:45] Equipment: Automated systems should be controlled in-line with ISO 22716. Equipment should be suitable for purpose and capable of regular cleaning and maintenance to avoid contamination.  

[17:02] Materials Management and Operation: How well do you control your materials? What controls do you have in place for manufacturing and packaging? How good is your storage? What is your delivery process? Do you keep documentation of all your purchasing and quality checks?

[18:15] Materials Management and Operation: Stock – Consider how you manage and store stock, include regular checks to ensure it’s all well within date. The Operations area in particular aligns with ISO 9001 – Quality Management.

[19:40] Materials Management: You need to set the criteria for quality during different stages of manufacturing i.e. specifications for raw materials, components and packaging material. This should also include release parameters.

[21:00] Materials Management criteria can be set out in a checklist. Mel mentions ‘The Checklist Manifesto’ as a recommended read

[24:15] Materials Management: Make sure you store in a way that avoids any contamination or mix-ups. Ensure all containers are stored off the floor. Use clear labelling to show if they are accepted, rejected or quarantined

[25:37] Operations: Should be carried out according to manufacturing documentation i.e. suitable equipment, product formula, details of the product process ect.

[27:15] Quality Control: Consists of sampling, specification testing, out of spec investigations and release. You may subcontract out quality control – in which case, you must ensure you get proof that they are conducting adequate tests.

[29:13] For subcontractors – Ensure you have a written contract OR agreement in place. If your subcontractor is subcontracting along the work, you need to ensure that process is controlled

[31:32] Deviations: These can happen at any point in operation and can be both internal and external in origin

[32:09] Complaints and Recall: You need to have processes in place to log and deal with complaints and recall. You should also regularly test your product recall process

[33:20] Change Control: Making sure you have effective processes and documentation to control any changes to existing operation. I.e. if you get different machinery that changes mixing times

[34:50] Internal Audits: You need to have an internal audit program in place and have competent independent personnel that can carry those audits out. This could be sub-contracted out

[36:10] Documentation: You will be documenting all throughout the manufacturing process, it’s integral. Ensure all staff know the importance of it and how to complete it correctly.

We’d love to hear your views and comments about the ISO Show, here’s how:

• Share the ISO Show on Twitter or Linkedin
• Leave an honest review on iTunes or Soundcloud. Your ratings and reviews really help and we read each one.

Subscribe to keep up-to-date with our latest episodes:

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