26 Sep Meet mcardle skeath’s RP’s (responsible person)
Thomas Russell & Claire Little
Describe the role of an RP in McArdle Skeath.
Thomas: The role of RP within McArdle Skeath is to ensure that the Organisation complies with the Principles of Good Distribution Practices along the supply chain from receipt to despatch of goods on behalf of the client. The RP creates and implements systems that ensure that we can consistently store our clients products in an environment that maintains the quality of the product and that procedures are adhered to throughout the business.
It is the role of the RP to highlight quality related issues and communicate to the relevant stakeholders and regulatory body.
Claire: The role of the RP in McArdle Skeath is to develop, maintain and enhance the Quality Management System (QMS) ensuring compliance with the conditions of the Wholesale Distribution Authorisation (WDA) and ensuring the quality of medicinal products handled.
The RP must comply with the guidelines on Good Distribution Practice (GDP) to ensure compliance.
Describe your role on the quality team.
Thomas: In McArdle Skeath my role involves training staff in GDP and related SOP’s. The regular monitoring and sign off on temperature reports in chilled areas of +2oC to +8oC, controlled ambient +15oC to +25oC and monitored ambient range of +5oC to +25oC.
Other aspects of my role in the quality team includes report writing, drawing up Service Level Agreements, Standard Operating Procedures along with internal and supplier audits. Occasionally liaising with clients regarding specific queries and developing solutions to assist with their requirements.
The Quality Team in McArdle Skeath undertake the qualification and mapping of equipment. This consists of regular validation of temperature controlled areas and refrigerated trailers to provide assurances that our equipment operates within their specification.
Claire: As Quality Assurance Specialist and RP, my role is to manage and maintain Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP) within McArdle Skeath.
My role involves being the primary customer contact on all quality related issues and queries, compliance requests, audits and customer complaints at our Inniskeen site. This includes training of all personnel, ensuring all employees are aware of GDP, ensuring the approval of suppliers and customers and ensuring compliance to national and international standards.
How do your skills and experience benefit the quality team? (What you did before McArdle Skeath)
Thomas: I have worked in Quality over 12 years within the manufacturing and supply chain industry. My experiences include working in a laboratory environment sample testing on a production line to liaising with clients and regulatory bodies during audits. I worked under GDP Guidelines for 5 years and within that time managing and maintaining quality management systems.
Claire: Prior to joining the McArdle Skeath business in November 2018, I worked in the Food Industry within the Dairy Sector. During this time, I worked in various roles within Quality and Technical Departments. I was involved in all customer audits which I feel has greatened my knowledge of customer requirements and this has benefited me in my role at McArdle Skeath.
What are your achievements to date in your position? (Successful audits and accreditations HPRA, BRC etc.)
Thomas: I have facilitated several regulatory and industry compliance audits during my time with McArdle Skeath including ISO9001, BRC Storage and Distribution, Department of Agriculture and Marine Licenses (Process, Storage, Transport & Repackaging), Wholesale Distribution Authorisation audits by the HPRA.
It’s only possible to achieve these accreditations / licenses within a strong team of inter-departmental personnel from Quality through to Finance, Warehouse Operations and Transport.
Claire: I have been involved in the ISO 9001:2015, BRC Storage and Distribution and HPRA audits with McArdle Skeath in both the Inniskeen and Hollystown sites along with various customer audits from the Pharmaceutical, Medical Device and Food industries.
How many Audits does the business have every year? (Regulatory bodies & Customer)
Thomas: In 2018 there were a total of 33 external audits from clients, 3rd party certification and regulatory bodies. We also carry out 12 internal audits and inspections on our quality management systems according to our annual schedule.
Claire: In 2018, there were over 30 Regulatory and Customer Audits across the Inniskeen and Hollystown sites. To date this year, we have had over 20 audits with additional audits scheduled to the end of the year.
Each audit is different which benefits the Quality Team as we are always building our knowledge and developing our skills.
In addition to this, Internal Audits are also performed within the business. Each Internal Audit is listed in our Internal Audit Schedule along with planned dates, durations and completion dates. There were 14 Internal Audits scheduled for 2019, including audits of the Quality Management System, Facilities, Security, Supplier Management and Purchasing, CAPAs and Non-Conformances, Training and Personnel.
The Internal Audit process includes planning and reviewing previous audits, conducting the audit, reviewing QMS documentation and other relevant information, reporting the results and a final review of the results by the Quality Manager and RP.
The Quality Team also perform Housekeeping Audits every month. This involves a full walkthrough of the warehouses, yards and office buildings to ensure compliance to regulatory and customer standards.,
Looking at current QA trends, what do you think clients want?
Thomas: Clients are looking for a quality driven supply chain solution to manage and protect their product to the same requirement as they would provide. They want a traceable system that can track the process from receipt, storage and dispatch in an environment that is well maintained and supported by the relevant stakeholders.
Claire: I believe that the Pharmaceutical sector are setting the standard within Quality Assurance. The Food Industry is now moving in the same direction and standards are increasing. Through regular communication with our clients, McArdle Skeath are able to develop our relationships with our clients to ensure we are able to meet their compliance requirements.
What systems/tools do the McArdle Skeath quality team have in place?
Thomas: McArdle Skeath carry out regular validations on warehouse and transport storage. This displays a level of compliance and confidence in McArdle Skeath by the client that equipment and systems are functional within our organisation.
Claire: The Quality Team have recently introduced a new Quality Management System (QMS) – MasterControl. This QMS is 21CFR Part 11 Compliant. The system was introduced in response to the growth of the McArdle Skeath business and also the expansion of the Quality Team. We are currently using this system for Document Control, Issue Forms, CAPA Forms and Change Control Forms. There are many modules within this QMS, including: Manufacturing Records, Quality Records, Quality Events, Risk Assessments, Suppliers, Audits, Projects etc. I can envisage the implementation of many more of these modules with McArdle Skeath.