Auditing for Quality Manufacturing- Part-II

Creating a Culture of Quality

In this article, we will give emphasize on the Quality culture of the organization. The FDA has consistently prioritized the development of a culture of quality, urging both drug manufacturers and device manufacturers to embrace this overarching principle.

Beyond the FDA, several international regulatory bodies and advisory groups have issued guidance emphasizing the importance of fostering a culture of quality. For example, the PIC/S, in its document "Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments," states:

"Management should aim to create a work environment (i.e. quality culture) that is transparent and open, one in which personnel are encouraged to freely communicate failures and mistakes. Organizational reporting structures should facilitate the flow of information between personnel at all levels (6.3, Quality Culture).”

The MHRA also addresses the concept of a culture of quality in its "GxP Data Integrity Definitions and Guidance for Industry," highlighting two principles that specifically mention this concept:

“3.1 The organization needs to take responsibility for the systems used and the data they generate. The organizational culture should ensure data is complete, consistent, and accurate in all its forms, i.e., paper and electronic.”

“3.3 The impact of organizational culture, the behavior driven by performance indicators, objectives, and senior management behavior on the success of data governance measures should not be underestimated. The data governance policy (or equivalent) should be endorsed at the highest levels of the organization.”

The WHO also emphasizes a culture of quality in its "Guidance on Good Data and Record Management Practices":

“1.4 Examples of controls that may require development and strengthening to ensure good data management strategies include but are not limited to: adoption of a quality culture within the company that encourages personnel to be transparent about failures so that management has an accurate understanding of risks and can then provide the necessary resources to achieve expectations and meet data quality standards.”

Later in the same document, WHO expands on its vision for a company’s culture of quality, outlining key principles for data management best practices:

“4.7 Quality culture. Management, with the support of the quality unit, should establish and maintain a working environment that minimizes the risk of non-compliant records and erroneous records and data. An essential element of the quality culture is the transparent and open reporting of deviations, errors, omissions, and aberrant results at all levels of the organization, irrespective of hierarchy. Steps should be taken to prevent, and to detect and correct weaknesses in systems and procedures that may lead to data errors, thereby continually improving the robustness of scientific decision-making within the organization. Senior management should actively discourage any management practices that might reasonably be expected to inhibit the active and complete reporting of such issues, for example, hierarchical constraints and blame cultures.”

A true quality-focused culture, it is argued, is one in which employees not only follow guidelines but also consistently observe others prioritizing quality and making quality-based decisions. A corporate culture communicates to employees and others what the company values and what’s important to its management.

There are warning signs that a company lacks a culture of quality, including:

? The CEO and other senior executives rarely discuss quality, let alone performance against quality objectives;

? The company’s quality vision is either nonexistent or has minimal linkages to the business strategy.

? Managers throughout the organization either fail to consistently emphasize quality or are resistant to quality initiatives;

? The organization has few, if any, feedback loops for the continuous improvement of processes;

? The company lacks formal mechanisms for collecting and analyzing customer feedback;

? Metrics used for performance evaluation feature little to no mention of quality goals;

? Employees are unfamiliar with the company’s quality vision and values—or, perhaps worse, they view them as mere slogans;

? Training and development do not emphasize quality;

? New hires are not formally introduced to the organization’s quality vision and values; Or, the organization experiences frequent, though often minor, setbacks owing to inconsistent quality.

Measuring Quality

But how can you measure, in an audit, something as seemingly amorphous as a company’s culture? In theory, "If quality attributes equal quality behaviors, and quality behaviors equal a quality culture, then by measuring the quality attributes you'd be able to measure the culture.”

In my opinion, quality attributes that could be measured include:

? Deviations reporting; ? A change control system; ? A CAPA system; ? A complaints management system; and ? An environmental monitoring program.

Quality behaviors, on the other hand, must be carefully observed or experienced and are more subjective. These include communication and transparency, rewards and recognition, engagement, and a company’s cross-functional vision. If the attributes could be measured and linked to quality outcomes, these behaviors could be assumed. The focus should be on seven areas:

1. Prevention programs;
2. Quality management and issue escalation;
3. Training and personnel development;
4. Quality system management;
5. People and communications;
6. Continuous improvement; and
7. Site metric reporting.

Quality attributes and actions that are most closely correlated with an overall culture of quality:

1. Attending and participating in professional conferences to stay current in the field;
2. Collecting error prevention metrics;
3. Communicating that quality is everyone’s responsibility at the management level;
4. Utilizing proven technologies;
5. Creating clear performance criteria for feedback and coaching;
6. Maintaining an environmental program with trained staff (risk assessment, emission controls, spill prevention, and response);
7. Implementing formal quality improvement objectives and targets;
8. Including quality topics in at least half of “all-hands” meetings;
9. Collecting management review metrics;
10. Collecting employee turnover rate metrics;
11. Creating a program to show how employees' specific goals contribute to overall quality goals;
12. Creating a program to measure, share, and discuss product quality performance and improvement from the shop floor to executive management;
13. Instituting a continuous improvement program;
14. Putting in place a program that establishes a quality system maturity model, action plan, and tracking to measure progress; and
15. Collecting internal survey data to measure a company’s quality culture.

There is a dividing line between traditional quality systems and “enhanced” quality systems. The former might include, for example, systems for deviations, complaints, change control, disposition, CAPA, specifications, and environmental monitoring. The latter might include a risk management program, a knowledge management program, and a specific quality manual.

During audit, “You’re going to start by looking at the basics, and that’s ok. Then you’re going to look to see if there are any enhancements. This will give you a flavour of how serious they are about their culture. It’s not just the culture of the quality department. It’s the culture of quality within the organization. It has to be both top-down and bottom-up.”

Nowadays, FDA inspections are continuing to include more quality metrics. The agency has been developing its New Inspection Program (NIP), and while it’s far from set in stone, all indications are that it will include an explicit focus on quality culture.

“In a traditional inspection, the quality culture of a company was really only covered in an informal, associative way, but in the future, we can expect it to be more focused on quality culture. Now we’re seeing the door open to more questions that try to pinpoint the culture of an organization.”

I just hope you found this article useful in identifying the Quality culture of the organization.