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As we at Perry Johnson Registrars enter National Preparedness Month 2023, it’s imperative to highlight the importance of readiness, especially for vulnerable communities disproportionately affected by disasters and emergencies. This year’s theme, “Take Control in 1, 2, 3,” emphasizes preparedness for older adults, particularly those facing heightened risks due to factors such as living alone, low income, disabilities, or residing in rural areas.

In 2021, FEMA’s Ready Campaign and the Ad Council initiated a groundbreaking national preparedness campaign targeting the Latino community. It underscored the connection between personal planning for life milestones and disaster preparedness, emphasizing the significance of readiness within cultural contexts.

This year, the focus shifts to the Black and African American community, extending the commitment to put people first and reach underserved populations. National public service announcements will disseminate crucial preparedness information across the country, aiding those most in need.

For emergency managers and those supporting older adults, the new webpages in both English and Spanish offer essential resources. These tools enable better preparedness and resilience for older adults and individuals with disabilities.

For More Information and Resources:

• National Preparedness Month Social Media Toolkit
• 2023 National Preparedness Month Social Media Graphics
• National Preparedness Month Social Media Graphics (Past years)
• National Preparedness Month Animated Graphics
• 2023 National Preparedness Month Congressional Co-Chairs
• 2023 NPM Congressional Co-Chairs Graphics
• President Joseph R. Biden, Jr. Signs Proclamation for National Preparedness Month 2023
• Preparedness for Older Adults
• Personal Disaster Preparedness for People with Disabilities Social Media Toolkit
• FEMA Signed MOU with the Rosalynn Carter Institute for Caregivers

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In the dynamic world of quality control, several key trends are shaping the landscape in 2023 and beyond.

One significant trend is the shift from considering quality as a concern limited to manufacturing processes. Today, quality management principles extend across the entire value chain, from finance to warehousing and supply chain management. Customers now demand effective quality management systems from suppliers, and businesses failing to meet this demand risk losing their competitive edge.

Regardless of global inflation and economic challenges, quality management remains a top priority for businesses. The 22nd Annual Quality Spending Survey shows that 98% of US manufacturing companies consider quality as important as ever or even more so. With supply chain disruptions continuing to impact business, collaborative relationship management with suppliers and partners is vital for survival.

The hybrid workforce presents both opportunities and risks, prompting companies to adapt their risk plans continuously. Talent shortages, especially in entry-level and leadership sectors, persist as a major challenge for manufacturers. To mitigate this, businesses are implementing flexible work arrangements, investing in robotics and AI, and focusing on employee experiences. Combatting workplace partiality is also becoming a key focus, as organizations strive to create inclusive environments that promote diversity and equal opportunities for all employees.

Quality professionals are increasingly taking on roles in environmental health and safety (EHS), leading to a merging of these functions. Consequently, companies seek integrated software solutions that handle both quality and EHS needs. Additionally, cloud-based Quality Management Software (QMS) is gaining broad adoption, as remote audits become more prevalent.

As cybersecurity risks grow, quality professionals must incorporate risk-based thinking into their systems and processes. Strategic management of cybersecurity risks is becoming essential in the field of quality assurance.

In conclusion, the year 2023 brings a range of quality management trends that are redefining business practices across industries. Embracing these trends will be crucial for companies seeking long-term success in the ever-changing global market.

If you have any questions, feel free to contact us by phone at (248) 358-3388 or email: pjr@pjr.com.

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For over two decades, PJR has been working diligently with thousands of satisfied clients as a trusted certification body. While disputes may occasionally arise, we take pride in the fact that we only encounter an average of about 20 disputes per year. Understanding that disputes are an essential part of the certification process, PJR ensures that concerns are addressed and resolved in an organized manner. In this blog, we will explain what constitutes a dispute, the step-by-step process PJR follows to resolve disputes, and the possible outcomes that arise from this procedure.

Disputes, also known as “appeals,” refer to officially-filed disagreements raised by auditees regarding the conclusions drawn by the auditor. To initiate the dispute process, a PJR client contacts the PJR team at our headquarters in Troy, MI, requesting the “Dispute Resolution Request Form” (F-217). All dispute requests must be submitted within 15 calendar days of completing the audit, with each nonconformance documented on an individual F-217 form.

The F-217 form captures essential details about the audit in question. The “Resolution Request” section includes fields for:

1. Certification Criteria: The nonconformance number assigned by the auditor.
2. Auditor/CB Finding: A summary or direct copy of the nonconformance as issued by the auditor.
3. Justification for Dispute Request: A detailed description of the disagreement, encompassing points related to evidence, audit criteria, or other relevant aspects.
4. Description of Attachments: A comprehensive explanation of the evidence provided to substantiate the dispute, which can be submitted in any format.

Upon receiving the necessary forms and evidence, PJR schedules a dispute hearing. Led by the Dispute Chairperson, this hearing involves auditee representatives, the auditor responsible for the disputed nonconformance, and a Dispute Panel consisting of three Lead Auditors from the corresponding scheme. During the hearing, each side presents their perspective, and the panel may ask additional questions to clarify the situation.

After the hearing concludes, the Dispute Panel engages in a private discussion to render a final decision on the disputed item(s). This decision is considered binding and is communicated to the auditee. There are three possible outcomes:

1. Upholding the disputed nonconformance: The auditee’s argument against the nonconformance is rejected, and the nonconformance must be addressed accordingly.
2. Overturning the disputed nonconformance: The Dispute Panel accepts the argument against the nonconformance, and the nonconformance is removed from the official audit report.
3. Upholding but reducing the disputed nonconformance: In this scenario, part of the nonconformance may be considered valid, while other parts may be eliminated or reduced in severity. An updated audit report is provided in such cases.

If you have any questions regarding the Dispute Process or how it aligns with your ongoing relationship with PJR, feel free to contact us by phone at (248) 358-3388 or email: pjr@pjr.com.

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Change control guidelines are designed to mitigate the risks associated with product modifications, and strict adherence to these guidelines is important. Identifying the attributes of change should begin early in the development cycle, encompassing the manufacture of products for pre-clinical and clinical testing, as well as throughout the product life cycle. Every change in design or manufacturing processes must be thoroughly documented according to regulatory guidelines.

Typically, the control of changes is overseen by a change control committee or designated individuals, depending on the size and complexity of an organization. All discussions, meeting minutes, emails, and notes associated with changes must be included in change documentation, regardless of the number of people involved. A controlled change is defined by the establishment of all necessary documents, approvals, and data, while uncontrolled changes can lead to compliance violations if not properly reviewed and approved by quality control.

The specific processes involved in change control may vary depending on the organization, but they should include certain minimum requirements. A change request form is completed and submitted, with details such as the description of the change, potential impact on other documents, and dates of approval. The change control staff reviews the request form to assess the significance of the change and its alignment with current good manufacturing practices (CGMP). Once reviewed and approved, the change control staff submits the necessary documentation to the appropriate regulatory authorities.

While change control may seem straightforward for smaller-scale businesses, it becomes more complex as the organization grows and handles additional processes and products. However, there are solutions to streamline document collaboration through enhanced document sharing and meeting software. Storing documents in a centralized digital location with clear revision/change history, such as SharePoint, can reduce the need for additional (or manual) documentation.

When developing or optimizing change control procedures, it is important to consider the regulatory perspective. While there may be regional differences between regulatory agencies such as the FDA, ISO, and the EU, the general principles covered by CGMP guidelines include having written procedures for proposed changes, providing supporting data to demonstrate the quality of revised processes, ensuring all changes are controlled and documented, and recording and justifying any deviations from established control procedures.

For more information on change control procedures as part of ISO 13485 certification for medical devices, reach out to PJR via phone: (248) 358-3388 or email: pjr@pjr.com.

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Completing an R2V3 Transition audit is a big milestone for organizations in the recycling industry. PJR, a Certification Body, provides important insights to ease concerns and ensure a smooth due diligence process.

1. Understanding the Requirements:

PJR emphasizes the importance of clarity regarding certification criteria during the R2V3 Transition. SERI’s COP Advisory 22 (version 1.4) serves as a guide for organizations, clearly outlining the necessary steps. To summarize, a vendor must meet the following conditions:

• Possess an active R2V3 certificate, or
• Hold R2:2013 certification and have completed an R2V3 Transition Audit, and
• Have a scope of certification covering the required equipment, components, materials, and R2 Process Requirements.

2. Timelines and PJR’s Role:

PJR acknowledges the eagerness of organizations to obtain their certificates quickly. R2V3 is renowned for its rigorous requirements, leading to its credibility in the recycling industry. PJR strives to process audit packages in a timely manner, considering factors such as closure of nonconformities, auditor availability, and prioritization of urgent packages nearing expiration or facing active suspensions.

Although delays can be frustrating, PJR reassures its clients that they are committed to supporting them during the R2V3 Transition period. PJR appreciates the patience and confidence demonstrated by its clients and remains dedicated to providing the best possible service.

The R2V3 certification process and its impact on due diligence can be complex. Understanding these guidelines and timelines will help organizations ensure compliance and meet the expectations of suppliers. While delays may occur, PJR is dedicated to diligently processing audit packages and supporting its clients throughout the transition to R2V3.

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