Historically, the relationship between Quality and Validation has been dysfunctional, unproductive, and inefficient. These issues have had a negative impact in the operation of each organization. The negative impact translates to unnecessary delays in projects, increased cost, low morale, and conflict between the two organizations. This article discusses considerations and ideas regarding how to develop a partnership and functional relationship between Quality and Validation.
In recent years, there have been numerous presentations and articles written about the relationship and challenges between Quality and Validation. Most, if not all, of these articles and presentations have concentrated on highlighting the negative interactions between Quality and Validation. Statements such as, “QA [Quality Assurance] is not qualified to review and approve validation documents”, are quite common in some industry gatherings and conferences. Unfortunately, some conferences have gone out of their way to become a QA-bashing session without providing constructive ideas or solutions to address the challenges and hurdles between the two organizations. This article discusses the issues that create challenges between QA and Validation, such as the competencies and skill-sets of the Quality Unit, and methods to resolve challenges. This article also discusses ideas for efficiency, collaboration, and partnership development that is based upon a foundation of trust.
What is the Real Problem?
It is well known in the industry that the relationship between Quality and Validation can be challenging, adversarial, conflictive, and sometimes unproductive. Management and senior leadership sometimes find themselves asking the following questions:
- “What can be done to improve the working relationship between QA and Validation?”
- “Is the problem related to competencies, skills, experience, and hiring practices?”
- “Is the problem related to the lack of a quality mindset in Validation?”
- “Are quality expectations unrealistic and very conservative?”
- “Do we really need QA oversight over validation activities If so, what is an adequate level of oversight?”
For years, we hear the complaints and concerns regarding the relationship between QA and Validation; however, not many ideas or solutions have been discussed in our industry. Let’s revisit each question and the potential answer to each one.
What Can be Done to Improve the Working Relationship between QA and Validation?
The first step to improve the relationship between QA and Validation is to understand the root cause of the problem. Is the issue related to employee personalities? Are the right people in each role? Do they have the appropriate skill-sets? Do their performance goals include collaboration and partnership with each other as expectations?
An assessment should be performed to understand what causes the relationship challenges between the two groups. The assessment should focus on listening to the concerns of each organization and understanding the true root cause of the problem. It is important to remember that collaboration is easier to encourage than conflict is to resolve.
Is the Problem Related to Competencies, Skills, Experience, and Hiring Practices?
Based on the authors’ experience, often competencies, skills, experience, and hiring practices are the root cause of many of the issues between QA and Validation. The typical hiring practices for a QA professional are centered on the quality competencies and not the needs of the organization, which can be quite unique when providing QA oversight for validation activities.
Companies typically hire QA professionals with a background in deviations, corrective and preventive actions (CAPA), change controls, batch record review, and documentation control. Although these skills are necessary for QA to support the validation program, they don’t provide for quality professionals who can efficiently provide QA/Validation support. What is missing? Technical and validation experience and skills in Quality? We will discuss this topic in more details later in this article. Both teams can benefit from having their counterparts involved in the hiring process. Having your Validation and Quality teams involved provides opportunities for input into selected candidates.
Is the Problem Related to the Lack of Quality Mindsets and Skills in Validation?
The lack of a quality mindsets and skills in validation sometimes is one of the issues that create challenges between QA and Validation. The lack of a general understanding of the quality systems and how they apply to validation can be a source of frustration for the quality professional. A want of understanding of the regulatory requirements applicable to validation and how they impact related activities can create a significant amount of debate between QA and Validation. Typically, the industry hires validation professionals solely based on their technical skill and previous validation experience. The hiring process sometimes fails to identify and understand the basic quality systems skills needed to support validation activities. This often leads to issues of validation professionals with a very vague grasp of the quality systems and the perception that validation is not a truly regulated activity. In order to avoid these issues, it is critical that hiring practices integrate basic quality competencies as an expectation for validation professionals.
Are Quality Expectations Unrealistic and Very Conservative?
The authors note that sometimes QA expectations can be somewhat unrealistic and overly conservative. This is primarily proportional to both the skills and competencies gap found in the QA professional supporting the validation team and the incomplete understanding of regulatory expectations from the validation professional. Regardless of job function, as humans, we can default to the most conservative approach when faced with something that we don’t quite understand. During the authors’ time in the industry, they have seen the skills and competence gap as a driver for a more conservative QA approach on issues that are low-risk. In order to avoid unrealistic expectations and a default conservative approach, it is critical to identify the skills and competencies that are missing in Quality, align hiring practices with the business needs, increase training, and sometimes reassign staff who have the most gaps in their skills to general areas of quality. This will avoid the issue of QA professionals reviewing validation protocols like they are test release data or batch records.
Do We Really Need QA Oversight Over Validation Activities?
Simply stated, yes. However, the extent of the oversight is a point of discussion. We may find different answers to this question, which are influenced by different philosophies that sometimes depend on who is answering this question. Some vendors of commissioning services may argue that quality oversight is not required during qualification. Some other philosophies define quality oversight only for validation plans and summary reports. The level of quality oversight can vary based on the maturity level of a validation process. Some companies require QA oversight for all documents, including commissioning, test scripts, protocols, validation plans, summary reports, and technical specifications. This approach can be perceived as excessive and inefficient with longer cycle times when QA resources don’t have either validation experience or technical skills. The fact is that validation is a regulated activity that requires quality oversight. Regulatory agencies’ expectations for quality oversight may vary from inspector to inspector or between the regulatory agencies performing audits or inspections.
What is an Adequate Level of Oversight?
There is no one answer to this simple question. Quality should be involved in the development of the validation program and templates used for protocols and reports. An early agreement to the level of detail in these documents will facilitate subsequent document review and approvals. An adequate level of quality oversight should be based on the maturity level of a validation process. The higher the maturity level, the less QA oversight may be required. When the validation process maturity level is lower, more QA oversight may be required to support validation. Key indicator factors of maturity are the number of validation-related deviations during a period of time. A high number of validation deviations may indicate lower process maturity and a potentially higher need for QA oversight by qualified resources. In most cases, the level of quality oversight is based on the ongoing and evolving compromises and agreements between quality and validation.
The authors have a risk-based approach that provides quality review and approval of the following documents:
- Validation Master Plan
- Commissioning Plan
- System Specifications (URS/FRS)
- Summary Reports
The following documents are only reviewed by QA as part of the change control process:
- Test scripts.
The following documents are not reviewed by Quality:
- Design Specification
- Configuration Specifications
- Factory Acceptance Testing
- Site Acceptance Testing
- Loop Checks
- Commissioning Documents.
The relationship between Quality and Validation can be challenging and sometimes adversarial. These challenges can have a negative impact on the operational aspects of both organizations, resulting in inefficiency, inadequate cycle times, and low quality. Qualified QA resources with technical and validation skills are critical to provide adequate support to the validation team, and validation staff with a sound understanding of regulatory expectations will facilitate discussions with Quality. In order to have productive and functional relationship between the two teams, collaboration, open communication, and transparency are critical to develop.
In summary, the authors’ Quality and Validation teams have partnered on an oversight model that meets regulatory expectations and business needs. This risk-based approach provides a very efficient process with average cycle times of less than two days for validation documents. The low cycle times allows for a very lean QA team that reviewed and approved approximately 2000 validation documents in 2013.