Meet mcardle skeath’s RP’s (responsible person)

ThomasRussell & Claire Little

Describe the role of an RP in McArdle Skeath.

Thomas: The role of RP withinMcArdle Skeath is to ensure that the Organisation complies with the Principlesof Good Distribution Practices along the supply chain from receipt to despatchof  goods on behalf of the client. The RPcreates and implements systems that ensure that we can consistently store ourclients products in an environment that maintains the quality of the productand that procedures are adhered to throughout the business. 

It is the role of the RP tohighlight quality related issues and communicate to the relevant stakeholdersand regulatory body.

Claire: The role of the RP in McArdle Skeath is todevelop, maintain and enhance the Quality Management System (QMS) ensuringcompliance 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 GoodDistribution 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. Theregular monitoring and sign off on temperature reports in chilled areas of +2^oCto +8^oC, controlled ambient +15^oC to +25^oC andmonitored ambient range of +5^oC to +25^oC.

Otheraspects of my role in the quality team includes report writing, drawing upService Level Agreements, Standard Operating Procedures along with internal andsupplier audits. Occasionally liaising with clients regarding specific queriesand developing solutions to assist with their requirements.

TheQuality Team in McArdle Skeath undertake the qualification and mapping ofequipment. This consists of regular validation of temperature controlled areasand refrigerated trailers to provide assurances that our equipment operates withintheir specification.

Claire: As Quality Assurance Specialist and RP, my role isto manage and maintain Good Distribution Practices (GDP) and Good ManufacturingPractices (GMP) within McArdle Skeath.

My role involves being the primary customer contact on allquality related issues and queries, compliance requests, audits and customer complaintsat our Inniskeen site. This includes training of all personnel, ensuring allemployees are aware of GDP, ensuring the approval of suppliers and customersand ensuring compliance to national and international standards.

How do your skills and experience benefit the quality team? (What youdid before McArdle Skeath)

Thomas: I have worked in Quality over 12 years within themanufacturing and supply chain industry. My experiences include working in alaboratory environment sample testing on a production line to liaising withclients and regulatory bodies during audits. I worked under GDP Guidelines for5 years and within that time managing and maintaining quality managementsystems.

Claire: Prior to joining the McArdle Skeath business inNovember 2018, I worked in the Food Industry within the Dairy Sector. Duringthis time, I worked in various roles within Quality and Technical Departments.I was involved in all customer audits which I feel has greatened my knowledgeof customer requirements and this has benefited me in my role at McArdleSkeath.

What are your achievements to date in your position? (Successfulaudits and accreditations HPRA, BRC etc.)

Thomas:I have facilitated several regulatoryand 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’sonly possible to achieve these accreditations / licenses within a strong teamof inter-departmental personnel from Quality through to Finance, WarehouseOperations and Transport.

Claire: I have been involved in the ISO 9001:2015, BRC Storage andDistribution and HPRA audits with McArdle Skeath in both the Inniskeen andHollystown 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, 3^rdparty certification and regulatory bodies. We also carry out 12 internal auditsand inspections on our quality management systems according to our annualschedule.

Claire: In 2018, there were over 30 Regulatory andCustomer 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 theyear.

Each audit is different which benefits the Quality Team aswe are always building our knowledge and developing our skills.

In addition to this, Internal Audits are also performedwithin the business. Each Internal Audit is listed in our Internal AuditSchedule along with planned dates, durations and completion dates. There were14 Internal Audits scheduled for 2019, including audits of the QualityManagement System, Facilities, Security, Supplier Management and Purchasing,CAPAs and Non-Conformances, Training and Personnel.

The Internal Audit process includes planning and reviewingprevious audits, conducting the audit, reviewing QMS documentation and otherrelevant information, reporting the results and a final review of the resultsby the Quality Manager and RP.

The Quality Team also perform Housekeeping Audits everymonth. This involves a full walkthrough of the warehouses, yards and officebuildings to ensure compliance to regulatory and customer standards., 

Looking at current QA trends, what do you think clients want?

Thomas: Clients are lookingfor a quality driven supply chain solution to manage and protect their productto the same requirement as they would provide. They want a traceable systemthat can track the process from receipt, storage and dispatch in an environmentthat is well maintained and supported by the relevant stakeholders.

Claire: I believe that the Pharmaceutical sector aresetting the standard within Quality Assurance. The Food Industry is now movingin the same direction and standards are increasing. Through regularcommunication with our clients, McArdle Skeath are able to develop  our relationships with our clients to ensurewe 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 validationson warehouse and transport storage. This displays a level of compliance andconfidence in McArdle Skeath by the client that equipment and systems arefunctional 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 introducedin response to the growth of the McArdle Skeath business and also the expansionof 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, RiskAssessments, Suppliers, Audits, Projects etc. I can envisage the implementationof many more of these modules with McArdle Skeath.