How do you motivate your team to read compliance policies, be open in audits, or raise risks?
Motivating a team of employees with quality can be tough and can become even harder when presented with a diverse team.
As you will be aware - everyone responds differently to motivational methods. If you want to successfully engage all of your staff, it is important to identify what motivates different personality types and why.
Motivators include achievement, recognition for achievement, the ability to grow or advance a person’s career, the work itself, and responsibility.
Understanding which of these motivates different personality types will not only make you qualiy part of the business culture, but will encourage your employees to be the best version of themselves in the office.
The 6 different personality types and how to motivate each one:
Healers are imaginative idealists, guided by their own core values. They are concerned not just with personal growth but the growth of others around them.
TAP INTO THEIR CREATIVE MIND by telling them a task needs to be done in a unique way.
PUSH THEM TO FIND AN ALTERNATIVE ANGLE TO A PROBLEM that hasn’t been thought of before.
Visionaries want to analyse, understand, and influence other people. They enjoy challenges and exploring new ideas.
TELL THEM IT CAN’T BE DONE their love for a challenge will motivate them to prove you wrong.
ENCOURAGE THEM TO APPROACH TASKS IN AN UNSTRUCTURED WAY, placing few limitations on their ingenuity.
Providers are sensitive to the needs of others and are eager to please. They prefer to work in a harmonic and cooperative environment.
SHOW THEM HOW THE TASK IS GOING TO IMPROVE THEIR CIRCUMSTANCES.
PROVIDE THEM WITH STRUCTURE AND ORGANISATION, as they respond best to work that allows them to follow through and see results.
Supervisors are hardworking, keen to be in charge, and are orderly, rule abiding, and conscientious.
PROVIDE THEM WITH A LIST OF CLEAR, TANGIBLE OUTCOMES FOR A PROJECT.
ENCOURAGE THEM TO PROGRESS TO MANAGEMENT ROLES, as they need to be reminded, they are capable of progression.
Inspectors tend to be introverted, but not isolated. They are keen to understand their role and successfully meet the expected standards.
TELL THEM THAT THE COMPLETION OF A TASK RESTS ENTIRELY ON THEM.
WORK WITH THEM TO CREATE CLEAR PLANS A CLEAR PLAN OF ACTION that they can follow with little deviation.
Performers are spontaneous, energetic and sociable. They enjoy being the centre of attention.
TELL THEM HOW IMPRESSED OTHERS WILL BE IF THEY COMPLETE THE TASK.
ALLOW THEM TO BE SPONTANEOUS IN THE WORKPLACE to address different situations as they see fit.
It's completely normal to want to escape the nail-biting stress of a medical device regulatory audit.
Manual paper-based systems and reams of spreadsheets don't just make GxP operation trickier, they add unnecessary time and effort.
If you're looking for a compliance tool to streamline your route to market and simplify your FDA, ISO and CE marking requirements, you're going to want to weigh your options and compare potential vendors.
We stacked our EQMS platform against Atlassian's medical device quality management add-on, SoftComply.
Both EQMS by Qualsys and SoftComply eQMS can be applied by medical device companies to fulfil their key quality management objective:
To build, maintain and prove the existence of an ISO 13485 QMS, underpinned by GxP.
This objective is attained with management of three core elements:
SoftComply eQMS provides users with a 'pre-packaged' set of quality document templates to populate.
This is great if you're yet to put together a quality manual, policy, or any of your SOPs and QMS documents.
And SoftComply's templates are constructed with ease of use in mind, so everyone in the business can understand their content. Embedded info boxes and warnings allow users to easily stick to GDocP principles as they create and share documentation.
But full document control - with workflows and audit trails for approval and archiving - can only be achieved with a separate add-on, Comala Workflows.
A further tool, Comala Publishing, is needed to separate live and draft documents.
And both SoftComply and Comala require Atlassian Confluence to operate.
The Document Manager module within EQMS, in contrast, operates as a single integrated document management tool, with controls and customisable workflow pathways baked into the repository.
Unlimited free end user capability means electronic documents can be provided to anyone within your business, as well as shared with suppliers, customers and regulatory bodies.
The Navigator tool allows Quick Links and Favourites to be added for speedier access, while the Dashboard allows administrators to track key document metrics such as overdue approvals, document owners and the volume of various document types - adding an extra layer of top-down control to the QMS document set.
Digital control of documents is possible with either tool - and is crucial for GxP and ISO 13485 compliance.
But what about managing corrective and preventive actions, change requests, development incidents, internal processes and non-conformances?
You can achieve GxP, CE marking and 510(k) market approval for your medical device without electronic process control - but wastage and time reduction with consistent digital processes make GxP easier to embed and achieve.
SoftComply currently does not offer an dedicated process management tool or module, with Comala Workflows limited to document workflows only.
Qualsys customer York Instruments applied the Issue Manager module within EQMS to strengthen the route to market for their Class II medical device, handling a range of quality management processes electronically for simplified GxP.
SoftComply recognised the significance of risk within GxP and medical device quality management and responded with their Risk Manager add-on.
Like SoftComply eQMS, Risk Manager requires an existing Atlassian stack to be effective.
But it is built upon the core requirements of ISO 14971, providing users with useful functionality such as risk matrices and a central electronic risk register.
Audit preparedness is simplified by combining risk, requirement and test case information in a single area, allowing users to track, trace and treat risks with full visibility.
The Risk Manager module provided by Qualsys offers similar functionality with customisable risk classification and storage, with the addition of bespoke review reminders to keep the risk register fresh, optimised and up-to-date.
Modular interaction also helps support risk management within EQMS: associate issues and actions from Issue Manager to their connected risks, and apply CAPAs from Issue Manager to treat risks and update their residual scores.
The bottom line
If your business:
Has no existing quality documentation yet
Is already using Atlassian and Jira (or is planning to)
Is comfortable with applying a separate tool for electronic process management
Has a small number of staff planning to use the software
then SoftComply is a potential solution.
Have an existing QMS you're aiming to digitise
Aren't tied to Atlassian
Want to integrate your document, risk and process management in a single tool
Are planning to expand your user base long-term with unlimited free end users
then EQMS is better suited for you.
Dive deeper into the functionality of EQMS by downloading our datasheets:
Businesses can only be as strong, compliant and efficient as their supply chains allow them to be.
So getting a robust auditing procedure in place to keep tabs on your suppliers is crucial for embedding world class quality control.
We built an example supplier audit within our Audit Manager module to demonstrate how EQMS can be applied for good supplier control.
Step 1: head to Audit Manager and create a new audit
Start by heading to the Housekeeping section of Audit Manager and building a 'New Supplier Audit' audit type.
Then, as with any kind of audit you want to complete in EQMS, click the 'Add new audit' button at the top of your Audit List.
Name the audit after the supplier you wish to audit, give it a reference and owner, and detail the scope - which will be something like: 'new supplier audit for Supplier X'.
Associate your New Supplier Audit audit type, and click save to begin building your audit checklist.
Step 2: build the audit
After entering the scheduled date and expected duration of your supplier audit, make sure you associate your audit with relevant records from other EQMS modules and any associated standards and clauses your audit relates to.
Associated standards could be:
ISO 9001:2015: Clause 4.1 (organisational context)
ISO 9001:2015 Clause 4.2 (understanding the needs/expectations of interested parties)
ISO 9001:2015 Clause 8.4 (control of externally provided processes, products and services)
A good supply chain is built on candid and transparent pricing.
1. Is the supplier willing to provide open-book costing details for the products within scope?
2. Are development costs included in the price?
3. Are there areas where the supplier can drive innovation/improvement?
4. Are there resources available to support continuous improvement activities? If yes, how many FTEs versus total?
Responsiveness and communication
Your supplier relationships will live or die on the level of effective communication and response you can achieve with your supplier.
Use this section to gauge those levels.
1. Is the supplier competent in lean and 6S techniques?
2. Is there a structured approach to resolve business problems?
3. Are there project management capabilities present?
4. Detail the number of staff in the supplier company and their qualifications/competences.
5. What is the standard lead time following receipt of the purchase order?
6. What is the company's responsiveness for new inquiries?
7. Detail the flexibility of production within the supplier's manufacturing site(s).
8. To what extent does the supplier communicate proactively?
9. Is there a willingness to share detailed information on a voluntary basis?
Step 4: audit!
Take advantage of Qualsys'smobile auditing application to eliminate paper-based clipboard processes and begin auditing your suppliers quickly and simply.
If necessary, divide the audit between multiple auditors, record findings on-the-go via the iEQMS mobile app, then visit the main Audit Manager system to view the combined findings in a single, instant automated report.
Use Issue Manager to record and drive any necessary change actions or resolve non-conformances.
And keep your supplier on track and in the loop by sharing EQMS access with them and pushing any necessary actions into their To Do list.
Download our Audit Manager datasheets to learn more about the functionality of the module and how to apply it to your own auditing needs.
The Unilever Oral Care department faced the first major test for its new EQMS system in May 2019, as the auditors arrived for the annual ISO 13485 surveillance audit.
After becoming Qualsys customers and implementing EQMS in January, the Oral Care team worked to digitise their paper-based legacy system, transferring over 2000 records and documents into Document Manager and building an operational electronic medical device quality management system.
Paulo Ramos, Quality Manager of the Oral Care R&D department, commented:
Oral Care at Unilever just passed another successful audit against ISO 13485 with zero non-conformities.
With a challenging year where we moved from a paper-based system to a fully digital, software-based environment, EQMS enabled us to drive efficiency and radically improve our levels of quality and control.
Thanks to our Qualsys partners who have been with us on this journey!
EQMS proved to be a great tool and strongly contributed to the success of this audit.
Last month, Unilever emerged as the world's strongest manufacturing brand in Kantar's annual brand footprint ranking, with six of its sub-brands purchased more than a billion times in 2018.
Read about how Unilever started their EQMS journey here.
And see how they breezed through their audit by downloading our ISO 13485 software datasheets:
Every drug, device and clinical company wants to be able to predict how regulations and laws are going to impact their current and future processes.
Last month, during our GxP Product Advisory Group event, we invited Sion Wyn, who assisted the FDA as a consultant with its re-examination of 21 CFR Part 11, to share forecast changes to expect from the FDA and MHRA.
Sion's links with the International Society for Pharmaceutical Engineering (ISPE) and experience working in the industry, means he is in a unique position to see what's on the horizon for the drug, device and clinical sector.
Keep ahead of the game with the five most important FDA and MHRA trends of 2019.
1. Expect pressure to digitise
Fear of validation costs has often meant the industry has been slow to adopt new technologies.
Cost of system validation is often up to two times the amount of the base system cost.
This was an eye opener for the FDA which meant many companies are still relying on manual, paper-based systems. But this causes endless communication, data integrity and quality challenges.
You can expect a lot more pressure from the MHRA and FDA to digitise your management system and more expectations to use a risk based approach to validation.
2. Focus on culture
The FDA and MHRA wants organisations to use their quality management system as a strategic weapon for competitive advantage, but acknowledges there needs to be a change in mindset for many businesses.
For example, Sion said:
Many used to focus on quality control. Then we moved to quality assurance. The next phase is all about quality improvement.
Quality control --> Quality assurance --> Quality improvement
The FDA and MHRA have noted that current complexities in regulation can sometimes make it too challenging for companies to focus on the most important matter - patient safety.
Their priority is ensuring patients have access to high quality, safe and effective medical technologies.
A major goal is simplification which includes aspects of increasing adoption of technologies and how to lean out validation.
4. No more compliance
While the FDA usually evaluates a manufacturer’s compliance based on each requirement in the regulation, in 2017 CDHR launched a new initiative – the Voluntary Medical Device Manufacturing and Product Quality Pilot Program, which set out to encourage organisations to go above and beyond baseline compliance. The group hypothesised that by focusing more on patient safety than compliance, this would result in higher quality outcomes.
Partnering with CMMI, MDCI and other regulatory and industry partners, the aim was to drive continuous improvement and organisational excellence using the maturity model framework.
This was tested by 9 organisations. They benefited from:
Foregoing surveillance, post approval and risk based FDA inspections
Streamlining submissions for manufacturing change notices, site changes and PMA notifications
Simplification. increasing adoption of technology and lean out validation
In the future, we’re likely to see more programs which focus on critical-to-quality rather than line-by-line regulatory compliance.
5. No more compliance
The FDA wants to move away from a world where you are excessively worried about complying with 4.1.a, and more of a focus on whether you are addressing key business opportunities, risks and vulnerabilities. In fact, they said 80 percent of your role should be focusing on quality, 20 percent on compliance - not the other way around!
See it in action: Case study with York Instruments
No matter how regulations and laws change, quality professionals can future proof their management system through critical thinking and risk based, agile approaches which streamline assurance activity and evidence capture. Find out how this approach is working for Stewart Wilson, Quality Manager at York Instruments who says he now looks forward to being audited.
Want to meet EQMS users, hear from the Qualsys team, and learn from industry experts?
Our next user group on is set to be the biggest ever.
Read below to find out why quality experts from across the UK are heading to Sheffield next month and how to reserve your space.
Why attend a user group?
Connect with your community
Hear how users like you are finding success using EQMS
Learn from experienced and knowledgeable industry leaders
From new risk apps to global search functionality, topics at Qualsys user groups cover numerous tools and technologies designed to create a culture of quality improvement
Leave with an actionable plan to help you create a culture of improvement
Bring key insights back to your business
Grow your professional network
What are Qualsys user groups?
Qualsys user groups are free, in-person bi-annual meetups that are open to all EQMS users. User groups are typically hosted in Sheffield, and are designed to help you master all things quality, compliance and technology.
Each user group tackles a quality, compliance or business management system related theme and is presented by the Qualsys team.
User groups help you mature your management system by leveraging in-person education and networking.
From day one Qualsys have been tremendously responsive to development requests, and days like this will only help the ongoing improvements”
"A QMS is a coordinated set of values and processes implemented by an organisation to ensure and demonstrate that it meets the standards demanded to satisfy its customers’ demands and expectations."
The international ISO 9001:2015 standardis the accepted statement of the broad requirements of a quality management system.
Why is a QMS important?
A fully operational QMS will help an organisation to meet and demonstrate that it has met certain goals:
Consistently meeting customer requirements.
Consistently managing internal requirements.
Consistently managing external requirements. e.g. the effective allocation of resources
What are the benefits of implementing a QMS?
Implementing a quality management system will result in a number of long-term commercial gains. Here are just a few benefits of effectively implementing a QMS:
Achieve organisational goals
Reduce costly errors and wastage
Boost customer satisfaction
Market your business more effectively
Manage growth more effectively
Improve documentation availability
Correct issues to continually improve products and services
Grow market share in new territories and market sectors
Create a culture of quality
Embed vision into all projects
Better internal communications
Effectively measure performance of individuals and teams
How does a QMS support an organisation to manage cultural issues?
Implementing a quality management system can ruffle the feathers of employees. It can take them out of their comfort zone and away from institutionalised processes. This is why support from operational and executive management from the outset is critical to the implementation of a quality management system.
Qualsys has worked with hundreds of quality managers and always found that it is best practice to get management to promote quality. It is advisable for managers to embark on a routine of positive reinforcement during the early stages of the systems life. Not only will this promote system use but it will motivate staff.
To be effective, a quality management system needs to be robust, intuitive and flexible. The diagram below demonstrates how Qualsys's software modules interact to reinforce a holistic QMS.
Under a QMS, processes should be subjected to tighter management. It is wise to expect changes in the way staff interact and to expect changes in the distribution of responsibility and accountability.
It is important to take account of staff perception. Recognising existing employee attitudes and dispelling any concerns they hold is a vital part of managerial strategy when implementing a QMS.
Building on the theme of staff communication, when implementing a QMS an organisation should not shut its ears to employee suggestion. Employees are the ones who will use the quality management system so making any necessary amends to fit their needs and improve usability makes sense.
It is also advisable for an organisation to allow for an initial lag phase before improvements become the norm.
A quality management system offers peace of mind that regulatory requirements are being complied with and that the organisation is continually adopting a customer-centric approach.
A quality management system requires a number of essential elements. Here are five of them:
A quality policy and quality objectives. These statements must be documented.
A quality manual including scope, justifications for any exclusion, documented procedures and process interaction descriptions. This will specify how a QMS will be observed and emphasise the company's commitments to both continuous improvement and quality.
Any document procedures required by the compliance standard.
Any documents needed to ensure the effective operation, planning and control of company processes.
Records such as evidence of conformity to requirements and of effective QMS operation will be required by the compliance standard.
Operating in a Controlled Environment:
Many organisations deploy a quality management system to demonstrate compliance to regulatory requirements. A QMS can support an organisation operating in a controlled environment in a number of ways:
To ensure compliance standards are met, all company documents should conform to QMS processes.
This will ensure conformity in staff behaviour when performing their duties, a uniform data recording method and consistency in staff training.
The keeping of records such as audit findings, data monitoring, non-conformance reports and corrective actions etc. can be used as proof of QMS use and effectiveness.
A QMS can be used to enforce the required approval and disposition of documents and records.
It is important that only the most up-to-date version of documents are available to company users. To be compliant documents should have unique identity and version control when subjected to change.
The signatures of authors and approvers of the document may be required.
A summary of document history showing changes and dates of revision may be required.
To ensure that all records are both traceable and retrievable, records must be managed and controlled in a similar manner to documents; it is advisable to assign them unique identifiers, which will be supplied by an electronic QMS tool.
The Importance of Hierarchical Organisation:
Organisation is vital when dealing with controlled documents. A suggested hierarchy for managing QMS documentation is:
Any additional document types may be used at a company’s discretion. For example in this screen grab of an exemplar Document Manager structure:
Steps of implementation:
Implementation of a QMS is a multi-faceted challenge. Here is a rough plan for getting a QMS implemented:
General templates for all Controlled Documents that the company plans to use should be drawn up before QMS documents are written. Templates should have consistent styles and formats thus making them easy to read and navigate. All template procedures and instructions should have purpose, scope and responsibilities sections, templates must also meet controlled document requirements e.g. unique identifier etc. It is optional for a company logo to be included in a document header.
Many companies will have written procedures already in place, however these current procedures may not be up to scratch in terms of being out of date, incomplete etc. There may be some areas of the business, such as finance, that are not seen to fall under the scope of the QMS and existing procedures may be seen as the best option to achieve compliance. However any areas deemed not under the remit of the QMS must not have an impact on product safety of quality as these are under the jurisdiction of the QMS.
Companies should undertake a flowchart-style mapping of quality framework management processes. This helps to include all stakeholders in the process, highlights areas of non-compliance and missing documents, and is a great method of identifying areas where change is needed.
It is useful to map your QMS documents and structure according to hierarchy using process/document maps and organisation charts.
Documents should be drafted according to the specifications in the document maps; be aware of your audience and use appropriate language accordingly. A large international company with bilingual staff may need to publish documentation in several languages.
Electronic drafts should be managed appropriately. They should be documented and filed so that they can easily be identified, retrieved, reviewed, tracked and managed. The process used in the document control mechanism should be consistent to that used in the drafting process.
It is important for all documents to be reviewed by Subject Matter Experts from all areas affected by the document scope. Failure to review documents may result in a reduction of compliance, increase the risk of deviation from the QMS and create friction between staff/departments.
It is important to obtain the appropriate approval level for an issued document, this will be dictated by the compliance standard. Once issued and approved a hard copy of the document must be filed at a secure location. Once documents are published staff can be trained to use them.
Evaluate your existing business
Ensure implementing a QMS is necessary
Make sure that the processes are working
Revise these processes where necessary and undertake continuous reviews
Qualsys Customer Success Manager Tom Speddings is organising a charity rugby tournament for Cardiac Risk in Youth (CRY).
Qualsys Customer Success Manager Tom Speddings
"12 young people die of undiagnosed heart conditions every week in the UK. I've known three young rugby players who have died suddenly due to this heart condition," said Tom.
In 2017 Tom and Claire set up the Fancy Touch rugby tournament to arrange for the CRY charity to scan young people for undiagnosed heart conditions.
The fancy dress charity rugby tournament brings together over 20 teams
Tom added: "The tournaments got bigger each year. In 2018 we raised over £5000. The money raised has paid for hundreds of people to be tested for heart issues which would otherwise have gone undiagnosed."
2019 is set to be the biggest year yet with 24 teams entering the tournament.
Many organisations get stuck in their GDPR journey and need some fresh ideas to move ahead.
If you're already using our integrated business management software, you can request our GDPR checklist to be added as an audit in the Audit Manager module. Simply talk to your account manager for more information.
This GDPR checklist makes it easy for you to:
Schedule recurring audits
Don't miss a thing - everything is already in the system
Assign roles and responsibilities
If you're not already using our software, you can access a shorter version by downloading from the form below.
Data is everywhere in your business. By managing information security centrally, you can control policies, procedures, data flow, to ensure the confidentiality, integrity and availability of data is always considered.
Qualsys's integrated business management system delivers all the compliance controls in the background. There are audit trails for everything, electronic 'read and approved signatures', customised to-do lists, documentation version control, competency management, and much many more compliance features which ensure that you are compliant.
How many times a day do your quality, human resources, health and safety, environment, information security, or other managers get asked:
Where is that policy?
Where can I see my upcoming training?
Where do I find that document?
By having a central business management system for all employees, you can make it habitual for them to check the central system without needing to inefficiently hunt the business for the latest information.
4. Scale more easily
Integrated business management system software helps you to clearly identify roles and responsibilities, manage employee on boarding processes, view risks and opportunities. This provides growing businesses with an essential tool to scale.
When you have a simple tool to update individuals, groups, or the entire organisation changes to documents, training requirements, new customers, new compliance requirements, risks, or opportunities - it's much easier to keep employees aligned and focused on the same goals.
1Approach to quality
2Main business challenge
3EQMS project & Qualsys
4Using Qualsys's solution
5Impact of the project
Approach to quality
Main business challenge
EQMS project & Qualsys
Using Qualsys's solution
Impact of the project
Approach to quality
Main business challenge
EQMS project & Qualsys
Using Qualsys's solution
Impact of the project
An integrated business management system also improves organisational strategy planning by bringing risk, vulnerability and opportunity data into a central view.
7. Whole-brain thinking
An integrated business management system enables you to ensure a balanced approach to making strategic business decisions. Use data to inform complex problem solving.
You want your customers to consistently have the best products and services. Therefore you need to understand what 'best' looks like, then enforce repeatable methodologies to consistently rinse and repeat.
Qualsys's integrated business management system enables you to:
Collect risk, issue and NCR data from employees across the business
Push and pull data from other software in your business - triggering action-based activity