Quality Architech^®

A review of frequently asked questions with Christine Park:

Q. Please give me an example of the importance or risk management.

A. Risk management is important in the manufacturing process design and validation. The same stages and process you use for product safety can be used to identify the Critical To Quality (CTQ) steps in the manufacturing process. This activity should be a joint process between the development team and manufacturing. The developers have designed the product and should understand what steps in the manufacturing process are critical to producing a high quality product. Working hand-in-hand with the manufacturing 
team, developers can identify the process steps and/or critical reagents/ingredients/components for the product. Then the potential failures can be identified with appropriate mitigations determined and built into the process.

Q. In your opinion, what is the most effective CAPA system?

A. The most effective CAPA system is one that focuses on systemic issues rather than every possible failure that occurs. Remember, the basic quality principle of significant few versus trivial many applies. CAPA systems that handle each quality system failure as unique can become overwhelming and cumbersome. In these cases, the volume of work is often more than an organization can manage. If this situation occurs, the CAPA system becomes a larger compliance risk, because the volume can’t be effectively managed in a timely manner.

Q. Can you provide some recommendations on conducting an effective failure investigation?

A. Recommendations include:

• Use common sense.

• Don’t overlook the obvious – look for the most likely causes first.

• The problem should dictate the tool, not the other way around.

• Avoid analysis paralysis – don’t make a problem more complicated than it is.

• Most problems can have more than one root cause – remember, this is an integrated system. There are many touch points within processes. If you have identified those Critical to Quality (CTQ), you can be proactive in preventing failures.

• Tools are generic – you may need to modify the tool to fit the situation.

• Don’t generalize the investigation – ask more “why” questions. Be as specific as possible.

Q. What are some points to consider when evaluating the role your executive management team is playing in your own quality system?

A. Consider the following top-level points:

• When was the last time you reviewed and discussed the adequacy of your organization’s quality policy? Is this documented?

• How effective is your management review process? Do you provide data for data sake, or are you providing appropriate analysis to help executives be more aware of product and process quality, so they can make more effective business decisions?

• When was the last time you reviewed with management executive responsibilities in the QSR and performed a gap assessment of your system against requirements?

• Can you provide adequate evidence that the executive management team is actively involved with the quality system?

Q. What are some points to consider that would make our internal audit program more effective?

A. An internal audit is most effective when the following are considered:

• The audit plan should cover all business functions, as well as interactions and interfaces within the scope of the business unit.

• Use a systemic approach for auditing, rather than individual functional or process silos.

• The audit should cover all levels of documentation in place for the area being audited.

• Audit checklists are very helpful, but should not be the only source for defining what should be evaluated during an audit.

• Analyze non-conformances for systemic issues, not just individual failures.

• Present data to executive management at the higher process interaction level, as well as the lower functional area.