Risk Posts

Uncovering the Real Cost of Quality: 1-10-100-1,000-10,000

Uncovering the Real Cost of Quality: 1-10-100-1,000-10,000

Kevin Lee, Industry Solutions Consultant, Pilgrim Quality Solutions

Can you capture or even approximate the cost of quality defects? Is it possible to put a price on a true or potential product recall? For manufacturers whose products can mean the difference between life and death, the costs can be staggering. The cost to prevent quality problems? It pales in comparison. No matter the product, the cost impact can not only be in real dollars, but reputation, market momentum, and shareholder value. (more…)

Top Concerns for Quality Audits: 5 Highlights from Last Week’s SmartSolve Audit Management Webinar

Top Concerns for Quality Audits: 5 Highlights from Last Week’s SmartSolve Audit Management Webinar

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Recently, we hosted two live demonstrations of SmartSolve Audit Management. The webinar covered a number of topics including how to perform mobile audits, creating audit programs and schedules, working on audits, and managing audit followup.  The webinar also included live Q&A during both sessions.

Some key themes emerged during both sessions that helped us understand the challenges you may encounter when carrying out quality audits, and how SmartSolve Audit Management can help.

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What I Learned Through Surviving an Internal Audit

What I Learned Through Surviving an Internal Audit

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

It takes a substantial amount of planning and effort to carry out an internal audit, but the outcomes can improve your processes, the performance of your department, and your outlook. As you’ll soon see, undergoing an internal audit can be a learning experience regardless of your skills or expertise within the organization.

Now, here’s a slight disclaimer: As part of a marketing department, the processes I touch and work through are not directly related to product safety or risk. However, our marketing internal audit was a necessary preparation to drive our entire organization toward our ISO 9001:2008 certification. The tips that follow are not solely relevant to marketing, or to any particular process or department, but reflect a broad overview of what I learned through participating in the audit process. (more…)

Sample, Skip and Switch – The Basics of Risk-based Incoming Inspection

Sample, Skip and Switch – The Basics of Risk-based Incoming Inspection

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

You’re probably conducting incoming inspections today but if you aren’t taking a risk-based approach, chances are you’re performing inspections you don’t need to do and possibly overlooking the items which need to be inspected most.  Implementing a risk-based sampling system helps you spend less time and less money inspecting high-quality raw materials when you are already confident that they are good. You’re also able to pinpoint poorly performing raw materials and suppliers based on their inspection state. (more…)

The Anatomy of Great Risk-Based GMP Audits

The Anatomy of Great Risk-Based GMP Audits

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

If you’re responsible for planning and carrying out your company’s internal audits, you know how much planning and effort it takes to monitor your quality system for GMP and ISO compliance. As your quality system has matured, you’ve probably noticed that certain sites, departments, or processes require more of your attention, while others are consistently in compliance and don’t need as much assistance. If this is the case in your organization, it’s time for you to consider a risk-based approach to your internal quality system audits. (more…)

3 Ideas for Reducing Quality Risks

3 Ideas for Reducing Quality Risks

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Sometimes small changes make a big difference. You’re already doing the difficult work of managing your quality system to stay in compliance and keep product quality high. But there may be some areas where you can focus to further reduce quality risk. Here are 3 areas to examine if you’d like to make some quick gains toward risk reduction and continuous improvement. (more…)

FDA Seeks More Control over Drug Compounders

FDA Seeks More Control over Drug Compounders

Mark Crawford

Meningitis gets attention.

As a result of the national outbreak linked to a Massachusetts compounding pharmacy that has so far killed 32 people and sickened about 500 others, the FDA has petitioned Congress for more authority over compounding facilities. (more…)

CAPA Risk Management and ROI

CAPA Risk Management and ROI

Konyika Nealy, Director of Quality Assurance, Pilgrim Quality Solutions

CAPA systems provide a wealth of information regarding the quality of a product or process.  However, few companies fully leverage the power of this tool to realize its positive impact to the bottom line. For instance, it is commonplace for a CAPA to be initiated for each product quality-related complaint regardless of scope or severity. Over time, the system becomes laden with records, of varying degrees of severity, which are often vetted by issuance order rather than priority. As a result, the organization cannot optimally allocate resources to correct events that have the most impact on the business as a whole. So then, how can a company reclaim efficiency and perhaps even streamline the CAPA process? (more…)

The Newest Kind of Risk

Mark Crawford

It’s a high-tech world full of high-tech solutions that give us comfort and peace of mind. We’ve got risk and quality management practices in place that free us up to charge ahead with business—but do we look back enough over our shoulders, or do we fall victim to complacency—like, “Hey don’t sweat it, if it hasn’t happened yet it’s not going to happen.”   (more…)

Beware: Annex 11 Has Implications for Medical Devices

Beware: Annex 11 Has Implications for Medical Devices

Mark Crawford

In January 2011 the European Medicine Evaluation Agency (EMEA) released an updated version of the European Union’s GMP Annex 11 for computerized systems (Annex 11), as well as an expanded version of Chapter 4 on document management.

These are significant changes for the pharmaceutical industry—the new Annex 11, for example, is about four times larger than the older version. EMEA decided to overhaul Annex 11 to keep up with the increased use of computerized systems in all aspects of good manufacturing practice (GMP), as well as their increased complexity. Annex 11 now addresses the regulatory needs of modern IT systems and imparts extensive requirements for compliance at all levels—for example, it dictates how computer printouts of critical records must indicate if any data has been changed since the original entry. Other key topic areas include business continuity, incident management, electronic signatures, migrating and archiving documents, and more comprehensive security controls. (more…)