January's Quality Manager Tip of the Month
EDITOR'S NOTE: Welcome to the Quality Manager Tip of the Month. This monthly series of posts will bring you state of the art tips to make your job in quality management easier. Come back each month for a new tip!
Challenge / Obstacle: Lack of sufficient personnel to keep up with the amount of work the quality department is responsible for; a backlog of work in multiple areas has become the normal state.
Tip: Leverage Expertise from External Organizations
External consulting firms can be used to provide expert help for many of the standard responsibilities that the quality department is tasked with. These external organizations are ready to provide you with the necessary documents to get on your approved supplier list, and can jump into work at various stages. Look for organizations that have specialized experience in the area(s) you are looking for and they can quickly and effectively help.
External organizations can supplement your workforce with expertise in many areas. Some of the areas you may need support in routinely (normal state) are as follows:
- Quality system development or remediation. Experts can perform gap analysis to applicable standards and improve or design your quality system from the ground up. Technical writing of standard operating procedures (SOPs) also falls into this category, along with harmonization and implementation of those procedures.
- Quality system training. Outsource your annual GMP refresher training or specialized training needs. One example of specialized training is regulatory advertising and promotion training for your identified subject matter experts. All of the individuals involved in developing and approving advertising and promotional material for your medical devices and pharmaceuticals (not just the quality and regulatory folks) will need to know the applicable regulatory requirements for these materials to ensure full compliance.
- Compliance. Outsource management of your external quality system audits (FDA QSR, ISO 13485, etc.) Another great practice is to outsource the FDA required "internal" quality system audit using consultants or an expert auditing organization ensures complete independence of the auditor for every area of the quality system. Quality system and regulations training is also included in this category, along with assistance in audit observation responses FDA 483s or warning letters) and any remediation projects stemming from audits.
- Supplier management. Consultants are located all over the world, just like your suppliers! Use this situation to your advantage by hiring them to help manage your suppliers, conduct routine supplier audits and aid in strategic sourcing.
- Inspection readiness and audit support. External experts can conduct mock inspections using FDA quality system inspection techniques (QSIT), European Notified Body procedures, or other global regulatory auditing procedures that are applicable to your organization. You can also use these experts to help manage your planned inspections and provide post-inspection resources and support.
External organizations can also be used when you need a very specialized expert for a tightly defined, unique (and usually non-recurring) scope of work. Some examples are as follows:
- Global labeling projects – You can use external experts to define international labeling requirements and support implementation of large labeling remediation projects.
- Process validations – When moving to a new manufacturing facility, external support can help eliminate the increased burden and any downtime for setting up new manufacturing lines
- Equipment validations – When moving equipment or setting up new equipment, external support can be used to complete Installation Qualifications (IQ), Operational Qualifications (OQ) and Performance Qualifications (PQ). Also, external experts should be considered when upgrading manufacturing to automated equipment.
- Software Validations – External expertise is often used in the release process for a new software version, including software embedded in products, software used in the manufacturing process, and software used in the quality system.
- Complaints and regulatory reporting – Complaint remediation projects are a very common output of audits and inspections. Often these projects involve digging through data and reports, sometimes going back many years, and compiling adequate complaint and reporting documentation for regulatory authorities.
This article is related to the Product Data Sheet:
Utilizing external organizations can be a quick solution to your resource constraints. Keep in mind these industry standards and best practices when working with external organizations:
- Expert consultants typically cost about 2-3 times as much as a corresponding full-time staff member.
- Higher costs are offset by quick (and sometimes immediate) turn-around time. Since you are paying for industry experts, you don’t have to invest the time and resource in training or on-boarding.
- Project contracts should be very specific and include the exact details of the scope of work. Each project (or group of work) should have its own contract, or at least an appendix to the overall contract.
- Request to review the resumes of the consultants who will be assigned to work on your project(s).
- Setup recurring meetings with each project team so you can stay on top of deliverables and continually manage the progression of the work.
- Make sure you are not using external help for work that is outside of the scope of their contract. This will result in projects taking longer than expected and inevitably lead to an unexpected increase in cost.
A strategic quality manager knows when and how to use external resources to an organization’s advantage. With the right mix of internal and external personnel, your organization can meet and even exceed the established annual goals and milestones.
Jake Walton is the corporate operations and quality manager at MasterControl, Inc. Jake has worked in the quality and regulatory industry for more than 10 years and is a Certified Quality Auditor, as well as a Certified Quality Process Analyst with the American Society for Quality (ASQ). Well-versed in medical device, laboratory, pharmaceutical, and ISO regulations, he has been a featured speaker at the ASQ annual symposium, as well as the Utah Technology Council’s regulatory conference. Throughout his tenure, he has hosted more than 250 external audits by customers, the U.S. Food and Drug Administration (FDA), European Qualified Persons (QPs), notified regulatory bodies (ISO), Taiwan FDA, and the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA).