When establishing a quality management system, enterprises must adhere to the four fundamental principles!

When an organization builds a quality management system from scratch or overhauls an existing system to create a brand-new quality management system, it often requires an experienced quality inspection manager to ensure the work proceeds smoothly and effectively.

Quality inspection managers usually see building a quality management system from scratch as a great opportunity to showcase their skills and leave a deep impression on the organization's senior management. However, quality management systems built under this mindset often overlook fundamentals, exceed budgets, become overly complex or flashy, and fail to meet the organization's real needs. The following four basic principles can help quality inspection managers paint a grand picture of the quality management system on a blank "canvas."

1. Simplify Procedures

How to make the established quality management system comply with legal and regulatory requirements? The most effective way is to create procedures according to legal and regulatory requirements or adopt procedures that comply with these requirements. Smart people try to incorporate as many requirements as possible into one procedure. I have seen many new organizations fail because of too many procedures, with complexity far exceeding legal and regulatory demands.

"For consistency, compliance, and safety, the more work procedures created, the better." Although this idea is understandable, it is usually unnecessary. For example, if a company tracks how many potted plants employees keep and how often they water them, the company's procedures have gone to extremes.

For quality inspection managers who have created too many procedures, I have three suggestions:

First, identify the procedures that must be in place according to legal and regulatory requirements.

Second, identify which essential procedures can be merged. For example, there is absolutely no need to have two separate procedures for Corrective Actions (CA) and Preventive Actions (PA). These two procedures can be combined into one procedure called "Corrective and Preventive Actions" (CAPA).

Finally, evaluate the procedures selected through the above steps. Identify which ones truly simplify the organization's procedures. Also, determine whether these procedures make the organization's employees' work easier or increase their workload.

Quality inspection managers should also follow this rule: if a seemingly "ridiculous" procedure must be established, handle it as vaguely as possible. For example, if a standardized operating procedure (SOP) for watering plants must be created, do not specify when or how to water; simply simplify it to: keep office plants alive. Buy some cacti or similar plants for the office. If you accidentally kill even the cacti, then buy some silk flowers and finally write yourself a corrective and preventive action procedure (CAPA).

2. Avoid Stacking Legal and Regulatory Clauses

Early in my career, I had some experiences creating quality management systems from scratch in small organizations, which now seem unsuccessful. In the first week after being hired, to demonstrate my extensive knowledge, the standardized operating procedures (SOPs) I created were filled with content from the U.S. Food and Drug Administration (FDA) Code of Federal Regulations (CFR). Reviewing these SOPs now, I find they merely summarized the laws and regulations but did not mention the specific operating procedures needed to meet legal and regulatory requirements.

I believe these SOPs made the mistake of "stacking legal and regulatory clauses." This means they were filled with lengthy, confusing legal and regulatory language, but the real content of the documents was unclear. Stacking legal and regulatory clauses will cause work difficulties, yet senior management often prefers this approach when establishing work procedures.

Laws and regulations are usually written broadly. Despite detailed explanatory documents, organizations often ignore these explanations and simply copy and paste clauses into their work procedures. From the perspective of government regulators, when manufacturers write procedure documents that "stack legal and regulatory clauses," it reflects the mindset: "We don't know what we're doing, so we plan to copy and paste your requirements exactly as they are, hoping you'll be pleased."

Many organizations spend significant resources when establishing quality management systems, such as reallocating personnel from other projects or hiring consultants. Some organizations directly take others' procedure documents and merely replace words with synonyms, like college students who do not want to be accused of "plagiarism" but copy others' term papers.

Simplifying procedure language is the best strategy for implementing consistency. If your organization's SOPs do not clearly state how to perform work tasks, they need to be rewritten. SOPs do not need to impress partners, senior management, and auditors by stacking legal and regulatory clauses; they must be consistent with legal and regulatory requirements, simple, easy to understand, and step-by-step procedures.

3. Overcome the Dilemma of Quality Terminology Abbreviations

I have worked with partners from different backgrounds—some in fields like aerospace, medicine, automation, which are not under FDA's scope. Sometimes partners are unfamiliar with specific industry terms, but we often overlook this.

Once, when designing the system framework, we solicited opinions one by one. When it was the turn of a new partner James, who had no FDA background, I asked him what he thought about using PDP, SOP, and DES procedures in NPD as part of the QMS.

James just looked blankly at these abbreviations we threw at him until I explained their meanings, then he understood. Afterwards, I compiled a glossary of quality terminology abbreviations so that people lacking quality background would no longer be confused in similar discussions.

In fact, there are many ways to address the dilemma of quality terminology abbreviations. For example, repeatedly mentioning the full term in a document. This may seem tedious but allows anyone with any knowledge background to understand.

A better way is to provide each employee with a glossary of abbreviations including accurate definitions placed on their desks for easy reference. This procedure is good, but if new employees frequently need to look up an abbreviation's meaning, it is better to simplify the procedure by removing the cumbersome abbreviation.

4. Accelerate Document Flow

Imagine this scenario: You have spent weeks building a CAPA program that, in your eyes, is not just perfect but a work of art. You complete the document change control form and submit the printed document for review and approval. You believe that in this approval process, the operations manager will promptly forward your document to the regulatory manager, who will then send it to the engineering manager. But two weeks pass with no news, and you finally discover that the document is still on the operations manager's desk, buried under a pile of other papers. You realize that to speed up approval, you need to personally visit each department to follow up on the process.

For large organizations with many branches, using a powerful electronic document management system is the most effective way to streamline processes. All work requirements can be fulfilled within this highly functional system—generating approval emails, monitoring key process points, identifying gaps, and more. People no longer need to search for ridiculous paper documents. Although building an electronic document management system is very expensive, in the long run, investing in such a system is undoubtedly worthwhile for efficiency and time-saving.

However, even if an organization can afford a huge investment, blindly investing in an electronic document management system is also unwise. For example, in an organization aiming to quickly establish and implement a quality management system, with document approvers working closely together, paperless office is not practical. When an organization first establishes a quality management system, the more powerful, faster, and flashier electronic system is not necessarily the best fit. Without considering actual circumstances, blindly built electronic document management systems cause more trouble than value. It should be determined based on the organization's size and expectations for the electronic document management system.

Before rushing to establish systems and procedures, the quality inspection manager should ask themselves: How will auditors view this system? Can they understand it? How many steps must auditors go through to verify system compliance? What if the system fails after running for a year?

By not rushing to act, asking more "whys," and insisting on doing things simply, work procedures can be simplified and better workflows created. Focusing on the four basic principles above will help us take the first step in building a quality management system.