Quality Objectives and Business Objectives: The Importance of an Integrated Approach

Introduction

The revised GMP Ministerial Ordinance (enforced on August 1, 2021) requires management to establish a Pharmaceutical Quality System (PQS), and to document both the quality policy and quality objectives. This requirement is fundamentally aligned with the ISO 9001:2015 quality management standard and is based on the concepts outlined in the ICH Q10 Guideline and PIC/S GMP Guidelines.

Under Article 3-3 of the revised GMP Ministerial Ordinance, manufacturing operators must:

1. Document a fundamental policy for ensuring product quality (quality policy) and indicate the components of the pharmaceutical quality system procedures
2. Have the manufacturing supervisor or the organization responsible for quality assurance establish documented quality objectives for the manufacturing site based on the quality policy
3. Communicate the quality policy and quality objectives to all organizations and personnel involved in the pharmaceutical quality system at the manufacturing site
4. Allocate necessary resources to achieve the quality policy and quality objectives, periodically review the pharmaceutical quality system (management review), and take necessary measures based on the results

The Problem of Misalignment Between Quality Objectives and Business Objectives

However, even among companies that have obtained ISO 9001 certification, a common problem frequently occurs: quality objectives and business objectives are not substantively aligned. In other words, there are cases where achieving quality objectives does not directly lead to achieving business objectives.

In many companies, management tends to describe ideal content aimed at customers and regulatory authorities in their quality policy and quality objectives. Meanwhile, business policies and business objectives primarily focus on financial indicators and business expansion, such as sales growth, market share expansion, and global development.

This situation indicates the existence of a gap between “official statements” and “actual intentions” in business policy and quality policy. This is not a desirable state for any organization.

The Essential Philosophy Required by ISO 9001

ISO 9001:2015 and ICH Q10 require a more integrated approach. The fundamental philosophy is as follows:

Quality improvement generates the following effects, ultimately leading to the achievement of business objectives through this mechanism:

• Reduction of failure costs (defective products, rework, complaint handling, etc.)
• Process efficiency improvement and productivity enhancement
• Increased repeat business through improved customer satisfaction
• Enhanced corporate reputation and credibility
• Improved business stability through trust from regulatory authorities
• Resulting profitability improvement

In other words, achieving quality objectives must be structured to directly contribute to achieving business objectives. ISO 9001 explicitly requires this alignment between quality policy, the organization’s strategic direction, and business objectives.

Section 5.2.1 of ISO 9001:2015 stipulates the following regarding quality policy:

“The quality policy shall: a) be appropriate to the purpose and context of the organization and support its strategic direction; b) provide a framework for setting quality objectives”

This requirement demands that the quality policy is not merely an idealistic declaration but is substantively linked to the organization’s business strategy.

Quality Policy and Quality Objectives in the Pharmaceutical Quality System (PQS)

In establishing a Pharmaceutical Quality System (PQS), management must implement the following processes:

Formulation and Documentation of Quality Policy

The quality policy is positioned as a company-wide commitment by the representative of the corporate manufacturing operator and executives responsible for pharmaceutical affairs. Its content should include:

• Approach and direction regarding product quality
• Content that satisfies GMP Ministerial Ordinance requirements
• Content that promotes continuous improvement of the pharmaceutical quality system
• Commitment to compliance with applicable regulatory requirements

The document establishing the quality policy corresponds to the Quality Manual in the ICH Q10 Guideline and PIC/S GMP Guidelines.

Setting Quality Objectives

Quality objectives are documented under the manufacturing supervisor or quality assurance organization based on the quality policy. The following points should be considered when setting quality objectives:

1. Measurability: Quality objectives should be established as specific indicators whose achievement can be measured. Quantification where possible enables objective evaluation.
2. Alignment with Quality Policy: Quality objectives must function as specific means to realize the quality policy.
3. Utilization of Key Performance Indicators (KPIs): The ICH Q10 Guideline recommends establishing performance indicators to measure progress toward quality objectives. These KPIs enable continuous monitoring of the effectiveness of the quality system.
4. Linkage with Business Objectives: Confirm that the structure ensures achieving quality objectives ultimately contributes to achieving business objectives.

The Importance of Management Review

The revised GMP Ministerial Ordinance requires that, to achieve the quality policy and quality objectives, periodic reviews of the pharmaceutical quality system (management review) be conducted under the leadership of executives responsible for pharmaceutical affairs, including the representative of the corporate manufacturing operator.

Management review confirms the following:

• Evaluation of quality objective achievement status
• Determination of the suitability and effectiveness of the pharmaceutical quality system
• Appropriateness of necessary resource allocation
• Identification of areas requiring improvement
• Need for review or adjustment of next-term quality objectives

Through this process, it becomes possible to continuously confirm the alignment between quality objectives and business objectives and operate the PDCA cycle.

Practical Examples of Effective Quality Objective Setting

As a practical approach to integrating quality objectives and business objectives, the following examples can be considered:

Business Objective	Quality Objective (Integrated Approach)	Expected Effects
15% Sales Increase	Reduce product defect rate from 2% to below 1%Improve customer satisfaction score to 85 points or higherImprove delivery compliance rate from 95% to 98%	Increased repeat orders through customer satisfactionEnhanced brand valueNew customer acquisition
10% Cost Reduction	Reduce deviation occurrences by 30% year-over-yearShorten average CAPA completion period from 60 to 30 daysImprove primary test pass rate from 90% to 95%	Reduced rework costsReduced quality issue response work hoursEfficient resource utilization
Market Share Expansion	Maintain zero GMP inspection findingsZero deviations in product quality reviewsMaintain 100% compliance rate in stability monitoring	Increased trust from regulatory authoritiesCompetitive advantage through quality reputationAcquisition of new business partners

Through such an integrated approach, it becomes clear that quality improvement activities directly contribute to achieving business objectives.

Conclusions and Future Outlook

What kind of quality policy and quality objectives each pharmaceutical company establishes within its pharmaceutical quality system is of great interest. The important points are as follows:

1. Substantive Integration: The quality policy and quality objectives must be substantively integrated with business strategy, not merely formal documents
2. Measurability and Specificity: Quality objectives must be measurable and their achievement objectively evaluable
3. Management Commitment: As required by the revised GMP Ministerial Ordinance, executives including the representative must lead in establishing the quality system and allocating necessary resources
4. Continuous Improvement: Through management review, continuously confirm and improve the alignment between quality objectives and business objectives
5. Company-wide Understanding and Implementation: Communicate the quality policy and quality objectives to all organizations and personnel, and implement them throughout the organization

In the pharmaceutical industry, quality is a non-negotiable top priority. At the same time, to conduct sustainable business operations as a company, it is essential to build a structure where quality activities contribute to achieving business objectives. What the revised GMP Ministerial Ordinance and ISO 9001 require is the genuine integration of these two elements.

Each company is required to establish an effective pharmaceutical quality system that integrates quality and management, taking into account its own situation, product characteristics, and market environment. This enables the realization of both the provision of safe and effective pharmaceuticals to patients and the sustainable growth of the company.