We’ve worked with a myriad of firms across their lifecycle and budget constraints, and can offer some pros/cons of the various approaches in Table 3. Below are some general guidelines for maximizing value through automation.
- Start-up or early stage organizations can benefit from basic manual systems or hybrid systems that automate some of the more labor-intensive quality functions such as document control.
- Mid-market organizations can benefit from increased automation through hybrid or enterprise QMS systems that address multiple quality needs such as document control, deviations control, non-conformance, equipment calibration, equipment maintenance orders, audit, CAPA, change control, training and functions that control product outputs.
- Large organizations can benefit from enterprise QMS systems and integrating those systems with their ERP systems for even greater interoperability.
In working with digital systems, our clients have found web-based options can require less IT support than network or client-server systems. These web-based systems can encounter less organizational pushback than networked systems, especially from companies experiencing IT fatigue from automating other non-quality functions.
Generally automation projects are cost-justified on their labor savings, and this is typically the case with automating quality systems. However, the automation offers greater value by enabling organizations to focus more on driving quality than reacting or reporting metrics. For example, many digital systems provide automated scorecards and dashboards that highlight quality trouble spots, monitor cost of compliance, and provide deeper visibility into the supplier quality. With these insights, organizations can leverage more opportunities to improve strategic quality management.
Don’t underestimate the change management for staff in adopting electronic systems, especially if the company has been using non-automated systems for an extended period of time. Consider investing in training and change management services from experienced consultants familiar with your digital system to ease the learning curve.
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Maximizing Value from Continuous Improvement
Once your quality system has been developed and managed through your budget process, it is important the entire system is audited to assure your systems and resources fully meet the level of compliance against the company’s standards and regulations. Typically the initial audit should be planned at 3-6 months after implementing the QMS to give the organization time to get up to speed.
In this first true test of the quality system, companies need to make sure the quality system is compliant, complete and meets the planned budget. There are tradeoffs of internally conducting the audit versus outsourcing the audit to a well-qualified quality consultancy. It’s less expensive to conduct internal audits with a competent internal auditor than an external expert. Table 4 outlines the considerations.
Continual improvements to the quality system allow the organization ongoing opportunity to assess and enhance the system based on feedback from a number of different areas which typically include:
- Internal and external audits program
- Customer feedback
- CAPA system
- Product or process non-conformances
- Processing data
- Enforcement activity such as a FDA 483 or Warning Letter
- Costs relative to the budget
Companies often adopt a risk-based approach in evaluating and implementing improvements to maximize value and minimize risk of noncompliance.
Budget Maximizing Tips
Regardless of careful planning and prudent management of the quality function, quality leaders are sometimes required to trim their budgets. A few short-term areas to consider:
o Limiting travel by employees and choosing local contractors or consultants to minimize this expense.
o For organizations with multiple locations, consider leveraging the geography of the company’s quality personnel. For example, if facility A has an out-of-state supplier located near sister facility B, then facility A might be able to tap into the facility B personnel to perform the supplier audit. The travel savings could offset the cost to quality facility B personnel on the QMS audit.
o Delaying training can minimize this expense. Although it can be less expensive in the long run to raise the skill set of your employees in areas such as internal audits, some companies trim budgets by foregoing to deferring training.
o Group training is another possibility to minimize training expense. By training all your employees at once, companies can negotiate reduced training fees and may possibly eliminate department travel by having a trainer come onsite to the company.
- Delaying supplier audits – Sometimes audits can be scheduled to the next quarter or early next year to save expense based on the acceptable risk exposure.
- Group input – The quality team is the cornerstone of the QMS. Engaging these internal experts can identify creative opportunities to trim expenses while minimizing risk.
Today’s Quality leaders are responsible for managing the organization’s compliance and cost of quality, while driving customer satisfaction and maximizing their department budgets. Careful planning and judicious use of human capital and other resources are critical in deploying a risk-based strategy that delivers organizational results.
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Keith Matthews is director of quality systems at Regulatory Compliance Associates® Inc. He brings over 25 years of medical device industry experience in various quality management roles. Keith can be reached at firstname.lastname@example.org or at (262) 842-1250.