External review is never about "passing a test"; it's about tearing apart what we've taken for granted and reexamining it
Every external audit is essentially a breakthrough in cognition — it suddenly puts the work you're so familiar with in your daily life that you don't even need to think under the spotlight, forcing you to ask yourself: Am I doing this because it's ‘what I should do’ or because I ‘know why I'm doing it’
This external review by Teacher Wang is like a "cognitive key": instead of scolding me head-on, Teacher Wang gave me two specific suggestions to help me dispel the fog of "mechanical execution" and see the "underlying logic" behind the work.
I. First piece of advice: Find the "father" for the system - from "following regulations" to "understanding why the regulations are written this way"
When I joined the company, it already had a well - established management system. In the past, my understanding of the regulations was simply "just follow them". For example, the "Document Control Procedure" required that "controlled documents must be labeled with numbers", so I labeled them; the "Record Management Regulations" required that "records should be kept for 3 years", so I stored them. It wasn't until Teacher Wang asked, "Do you know why we need to label the numbers? Why is it 3 years instead of 2 years?" that I suddenly got stuck - I had never thought about "the origin of the regulations".
Teacher Wang's suggestion hits the nail on the head: Correspond each company regulation to the specific clauses of the standard one by one. For example:
- "Document sticker number" corresponds to "4.2.3 Control of documented information" in ISO 9001:2015. The core is "ensuring that documents are identifiable and retrievable" (in case of document updates, the old versions can be quickly recalled).
- "Records are to be retained for 3 years" corresponds to "8.5.3 Records of production and service provision" — the purpose is "to prove that the process meets the requirements and to have evidence for traceability when problems arise".
- Even the statement The audit frequency shall be at least once a year in the Internal Audit Procedure can correspond to 9.2.2 Planning of internal audits – the standard requires that the audit shall cover all processes.
This is not "matching the requirements according to the standards" but "establishing logic for the system". Previously, I thought that "the system is rigid". Only after the correspondence did I realize that the system is the "practical translation" of the standards, and the standards are the "theoretical origin" of the system. For example, once I found that the "Nonconforming Product Control Procedure" did not stipulate the "approval authority for concession acceptance". Corresponding to the requirement of "8.7.1 Disposal of nonconforming products" in the standard, which states that "disposal requires authorization", I immediately understood that what needed to be supplemented was not simply "the manager's signature", but "clarifying who has the power to make the decision on concession", which is the "controllability" required by the standard.
More importantly, after understanding the origin, implementation will change from "passive" to "active". For example, when pasting document numbers, instead of "just coping with inspections", I will actively check "whether the numbering rules cover the new version"; when retaining records, I will pay attention to "whether the three - year time limit corresponds to the product's shelf life" - this is just the beginning of being "knowledgeable".
Suggestion II: Don't "label randomly" when making judgments - Check against the standards during document review and follow the procedures during operations
Non-conformity item criterion determination used to be my pain point: either directly assign an operational problem to a standard (for example, the workshop didn't conduct the first-piece inspection, and I assigned it to 8.5.1 Production process control), or assign a system problem to a procedure (for example, the Internal Audit Procedure didn't specify the approval of the audit plan, and I assigned it to Article 4.3 of the ‘Internal Audit Procedure’). As a result, the rectification was always scratching the itch through the boots – just supplementing a record and that's it, without solving the root cause at all.
Teacher Wang's single sentence hits the nail on the head: The core of the judgment criteria is "to find the essence of the problem"
- If it is a case of "problems with the system itself" (for example, the "Internal Audit Procedure" does not specify the audit frequency), directly correspond to the standard clause (judge as "9.2.2 Planning of internal audits") because the problem lies in "the rule design does not meet the standard requirements".
- If it is a case of "non - compliance with the system in execution" (for example, the workshop fails to conduct the first - piece inspection as required by the "Production Process Control Procedure"), it must be matched with the company's procedural documents (judged as "Article 5.2 of the 'Production Process Control Procedure'") because the problem lies in "failure to execute the self - established rules" rather than the standard itself.
The difference between the two is like that between "laws" and "family rules": If the family rules don't state "return home before 10 p.m.", it means "the family rules do not meet the 'guardianship requirements' of the law" (corresponding to the standard); but if the family rules state it and you don't comply, it means "violating the family rules" (corresponding to the procedure) — Only when the judgment criteria are accurate can the rectification hit the nail on the head.
For example, previously when I judged the non - implementation of first - piece inspection in the workshop against the standard clause, the rectification was simply to supplement the records. Now, when judging against the procedure document, we need to investigate "why it was not implemented": Did the operators not learn the procedure? Or did the team leader fail to supervise? Was the training inadequate, or was the assessment not in place? In this way, the rectification changes from "plugging the loopholes" to "eliminating the root causes".
From "enforcement tool" to "rule manager": This is the real meaning of external audit
Teacher Wang's two suggestions essentially helped me complete a role upgrade - from being an "executor who only knows how to do things" to a "manager who understands why things are done".
What I'm going to do next is not "work overtime to make up records", but:
1. Create a standard mapping table for all systems: Correspond each clause of the Quality Manual, Procedure Documents, and Operation Instructions to the clauses of ISO 9001:2015, and identify areas where the systems do not cover the standards and areas where the systems conflict with the standards (for example, if a certain provision is looser than the standard requirements, it needs to be revised).
2. Re - sort out the previous non - conformities: Adjust the previously misjudged marks. Check which rectifications are just superficial efforts and which are fundamental solutions. Supplement the root cause analysis.
3. Actively learn the standard change points. For example, ISO 9001:2015 emphasizes risk-based thinking. I need to check whether the company's Risk Assessment Procedure stipulates the frequency of risk update and the effectiveness evaluation of risk response measures — these are all in-depth compliance points that were not noticed before.
Inspiration for peers: Don't be a "mechanical worker", but be a "person who understands logic"
In fact, the core of Teacher Wang's suggestion can be summarized in one sentence: Don't treat work as a "task", but as a "system"
- If you are a newcomer taking over an existing system, try the "system - standard mapping method": use standards to find the "parent" for the system, and you'll find many places where "the system fails to explain clearly" (for example, a certain regulation conflicts with the standard, or the standard has been updated but the system fails to keep up).
- If you often make non - conformity judgments, remember the principle of "checking documents against standards and operations against procedures". Judgment is not "labeling", but "pointing out the direction for rectification". Only by finding the "root of the problem" can the problem be truly solved.
Finally, I'd like to say that external review is never about "passing the test," but rather "forcing you to grow." When you no longer view audits as "a formality to deal with inspections" but as "an opportunity to understand the logic of your work," each audit becomes a process of "breaking out of the cocoon"—breaking free from the cocoon of "mechanical execution" and emerging as a butterfly capable of "in - depth thinking."
After all, there are many people who can "do it well", but only those who can "understand why they do it this way" are the real "experts".