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NEW QMS ACTIV HR Management Module

Training and managing personnel information plays a vital role in the success of a quality management system. Once trained and skilled, your employees not only ensure the quality of products and services delivered but also work to ensure that the organisation is compliant with industry regulations.

This simple ACTIV web-based application was designed so that you have a single point of access to all your relevant HR information and enables you to:

Identify training needs and easily convert these into targeted and manageable training plans

Demonstrate and maintain compliance with HR, Health & Safety and Environmental legislation

Involve your employees in their own personal development;

The feature will enable you and your employees to more easily maintain and manage HR related records for:

> Comprehensive Personnel Management tool

Employee personal details

Training/competency records and training event plans

Quick access and management of employee skills and certificates

Enhance employee objective effectiveness with regular appraisals

Holidays

Absences /Lateness Records

Performance management

Reports for quick data analysis and more…

Cost for QMS ACTIV HR Management Module with professional complimentary training included is available upon request.

If you would like more details on this module or would like it activated for your system please contact us on 1926 800153, email info@advenamedical.com, or contact your consultant directly.

As always, we hope you find this new feature useful and we welcome any feedback you have on it.

Priority actions for manufacturers

The day before the European Parliament was scheduled to vote on adopting a more FDA-style method of medical device regulation, the central European consumer organization issued a video of medical device horror story testimonials, particularly relating to breast implants. This has not helped industry to fight to avoid radical changes.

We (industry) all know that the PIP implant scandal relate to a manufacturer’s fraudulent use of materials, nothing about the EU device regulations but this consumer group believes that more centralized regulation is needed. If consumer groups get their way we could be moving away from the current system, which they criticize for allowing device companies to shop around for the most lenient regulatory body, to the direction of the US FDA.

All of the following points should be considered in relation to the new legislation:

a). Manufacturers should review their control of all critical subcontractors and suppliers (including OEMs if the manufacturer is own brand labelling). Care must be taken to ensure that no legal responsibilities have been delegated and that control is adequate and risk based.

b). Manufacturers should ensure that they have good systems for informing their Notified Body of changes to product ranges, quality systems, critical suppliers and the design of high-risk devices.

c). Manufacturers should ensure that there are written procedures describing processes which will ensure compliance to regulatory requirements. This would include compilation and approval of technical documentation, EC declarations of conformity, vigilance, and determination of class (etc.).

d). Manufacturers should ensure that they are aware of all relevant EU Commission documents including MEDDEVs and classification decisions and that the requirements are incorporated into the QMS and technical documentation.

e). Manufacturers urgently need written procedures for managing unannounced audits, although these are not a requirement to be audited.

f). Manufacturers should ensure that all technical documentation has been updated in line with current device design and manufacturing practice.

g). It is recommended that a check of production against technical documentation and a traceability audit be incorporated into the internal audit process.

h). Manufacturers should make a judgement whether their Notified Body is likely to find compliance with the new requirements difficult because of limited resources, low technical competence or low prices, and consider moving to a stronger Notified Body.

i). Manufacturers should be ready for all the new expectations and unannounced audits from the beginning of 2014.

j). Best practice for manufacturers would be to immediately review the Recommendation document and undertake an internal audit/gap review of processes and technical documentation to identify any areas of weakness and then to implement an improvement plan before the first Notified Body audit in 2014.

Manufacturers who have been implementing best practice, following MEDDEV guidance and ensuring that classification and borderline decisions have been implemented have little to do other than institute a procedure to manage unannounced audits. However manufacturers who have fallen behind current best practice or who have chosen a lenient or incompetent Notified Body will have to review and improve processes and documentation or expect significant non conformities.

For more information contact Advena at info@advenamedical.com; Follow us on Tweeter and blog.

Major changes to audits and quality management systems (QMS)

All of the following points should be considered in relation to the new legislation:

a). There is a high emphasis on the need to audit the premises of the (legal) manufacturer and also critical subcontractors and suppliers. This will lead to the need to visit all manufacturers annually including own brand labellers and to increased audits of critical subcontractors and suppliers where the manufacturer’s control is judged inadequate.

b). Notified Bodies will need to assess more critically whether the organisational structure and the qualification and competence of managers and staff is adequate to ensure compliance. Major failures of compliance will result in the Notified Body questioning whether the manufacturer has adequate regulatory, quality or technical expertise within the organisation.

c). In future, it will not be sufficient to demonstrate that all devices are correctly classified, that technical documentation is complete (etc.). The manufacturer must have up to date procedures that describe all the processes that ensure regulatory compliance.

d). Risk management will continue to be considered a critical aspect of the manufacturer’s QMS and the application of the process to devices will be regularly audited. Manufacturers should be aware that ISO 14971 alone is not sufficient and the EU regulatory requirements of reducing risks ‘as far as possible’ and applying safety principles ‘compatible with the state-of-the-art’ must also be incorporated into the risk management process.

e). Clinical evaluation for medical devices and performance evaluation for in vitro diagnostic medical devices will remain a high priority, so manufacturers should expect their processes and their decisions and documented justifications to be challenged more often during audits.

f). The Recommendation provides a non exhaustive list of critical processes on which parts of the audit will focus: ‘design control, establishment of material specifications, purchasing and control of incoming material and components, assembling, software validation, sterilisation, batch release, packaging and product quality control.’ The expectation of the Notified Body will be that the manufacturer must demonstrate tight control even if this activity is subcontracted.

g). Notified Body audits may in future include in the audit a reconciliation check of purchased quantities of critical material or components against production. This will be of particular importance for high-risk devices.

h). Manufacturers will be expected to use all available sources of post-market surveillance data including (where applicable) distributors, users and patients.

i). The Recommendation makes it clear that Notified Body audits should be annual, a frequency already adopted by most Notified Bodies.

j). The quality manual and policies must demonstrate that the (legal) manufacturer, including when there is an own brand arrangement, actively retains responsibility for all the Directive requirements and all the critical processes. All manufacturers must have access to relevant technical documentation and must make all physical manufacturing sites available for the Notified Body audits. Current guidance on own brand labelling will have to be amended to reflect these changes.

For more information contact Advena at ela@advenamedical.com

Web Based Quality Management System – ACTIV

Here at,  Advena Medical Ltd, we firmly believe that a smooth transition to a digital – paperless document workflow can set up an organisation for success, which is why we’ve developed an in-depth QMS System called ACTIV to assist our partners as they make the switch.

We have noticed that more and more organisations are switching to digital document workflows from traditional paper-based processes to improve document accessibility, security, and storage.

What are you waiting for? 

There is still a large school of thought that still see the QMS as a regulatory nightmare and hindrance rather than a management tool for efficiency and productivity.

In particular the problems are intensified where there are;

  • A large numbers of documents.
  • Multiple sites using the same procedures.
  • Remote workers.

As a consultancy we see all these problems, many first hand, as we don’t just set up quality systems for clients but actually run the document control for them from our Warwick office using the web-based ACTIV QMS system that is licensed for us to supply to the medical device industry.

 

ACTIV is a web-based QMS software package which can be accessed from any PC with internet access, around the world and enables you to electronically control:-

  • All your quality documents and records via a strict electronic change control process
  • Supplier/sub-contractor status, tracking audits, certification
  • CAPA’s to track actions and implement improvements
  • Customer Complaints to track progress
  • Customers status
  • Customer Feedback to enable you to send out questionnaires to clients in order to receive feedback as part of your post market surveillance.

 

Our experience has shown that the ACTIV web based QMS provides;

  • A system suitable for the smallest of organisations.
  • Dramatically improved system effectiveness, ease of implementation and management.
  • A process easy to convert to from any existing document system.
  • Easy QMS compliance from any computer connected to the web and suitable for multiple sites using the same procedures anywhere in the world with web access.
  • A straight forward document & record control with automatic change control and the storing of obsolete documents.
  • Easy and automatic control of continual improvement (complaints, non-conformity, audits).
  • Easy customer feedback (post market surveillance), supplier control and communication.
  • The option of single controlled access point (administrator) with alternate multiple other users with lower access level or just read only.  Each user, with a secure log-in, could be anywhere in the world.
  • Readily available and instant management information.
  • Readily available specifications, drawings, procedures, forms, records, guidelines, general information to all, and all paper-less.
  • An easy to operate process (training can be provided) or can be administered by a third party (such as us) remotely from the main site. Could also be audited by a Notified Body remotely from the site; a very important advantage
  • Measurable cost effectiveness.
  • Established processes currently used successfully for very many small to medium sized companies in Europe

 

Most modules enable results to be statistically analysed to produce graphs or tables (something auditors love to see).

Once set-up with the data on the processes and procedures used, and approved suppliers / sub-contractors are listed, an operator of the system just needs to be party to the purchasing, manufacturing and dispatch records, (including traceability) to keep it up-to-date.

If you are interested we would be more than happy to provide you with a free log-in to our Advena ‘demo system’ which will provide you with an idea of what the system looks like as well as enabling you to experience some of its benefits.

Contact ela@advenamedical.com  for costs and more information.

 

 

 

 

ELECTRICAL SAFETY TESTING

It is obvious that test laboratories are getting totally bogged down with the testing to EN ISO 60601-1 3rd edition. We recently got a message from Intertek that they could not take on any more EN ISO 60601-1 3rd edition testing as the risk management phase was taking too long and they did not have enough people!

Any client who still has a problem on this we may be able to assist by doing the Risk Study and linking it, by check list, to 60601-1 requirements.

Enquire to john.adcock@advenamedical.com

 

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