I wrote before about the way certain consultants are routinely hired by manufacturers to “make paperwork look good”. It is the norm in China.
However, some factory owners really want to manage their business in accordance with best practices. They are not looking for shortcuts. They understand that ISO 9001 is not very advanced but it is already a basis good basis — if applied correctly — on the road to operations excellence.
So, how can consultants help a relatively small factory get ISO 9001 certified, with the objectives of doing it right and in a short time (3.5 months is usually doable)? I listed the main steps below…
Confirming top management’s motivation
Is the boss, and the other key people in the company, motivated to do what it takes, over the long run? Do they understand the benefits of a strong quality management system?
Or are they just looking for a nice paper certificate that will reassure customers? In that case, they won’t do all the hard work…
Setting up a consulting team
- A champion — will manage the engagement, review all progress, and report to the client weekly.
- A project manager — will manage the schedule, the drafting work, etc.
- One or two consultants who are will support the project.
All are ISO 9001 certified auditors and are aware of the changes in the 2015 version of the standard.
Choice of the registrar
Usually, a multinational and famous company is preferable. The price depends on the number of man-days, which itself varies mainly in function of the number of staff in the factory.
First pre-audit and gap analysis
This is the first step. It is necessary to estimate how many days of work will be necessary to help get the factory ready for certification.
Consultants need the organization chart and, if possible, a brief description of the roles & responsibilities of each person on that chart.
(We like to say “pre-audit” because the organization needs to understand we are on their side and they should tell us the truth… people in Chinese factories react in a special manner when they hear “audit”.)
Drafting of the quality manual and a few forms
A manual is no longer required in the 2015 version of ISO 9001. And yet, registrars still like to see one. It needs to be drafted.
The factory might already fill out a few forms, but chances are some other forms are missing — they will need to be put in place, too.
After that, a first training is given to the staff so they can start using the forms properly.
First and second level procedures
The high-level procedures about who does what (and in what steps) when need to be confirmed or prepared.
After that, the second level procedures (often called ‘work instructions’ or ‘WI’) are necessary, especially when the “how” is not obvious (for example, no need to write a WI about the way to drive a truck).
At the same time, the consultant team needs to ensure the procedures make sense and don’t make operations more complicated than they need to be.
Training of a coordinator at the factory
It is good to pick a coordinator at the factory who will do a lot of the groundwork. That person can then keep maintaining the quality system over time.
That coordinator can draft some second’- and third- level documents, maintain the records, explain the requirements on a daily basis, push people…
Second pre-audit
A second pre-audit is done, to confirm improvement. This time there should be more records and more procedures to follow.
An important question is, ‘do people understand the requirements, and do they follow the requirements?”
Training of an internal auditor at the factory
It is good to send someone from the factory to follow an ‘ISO 9001 internal auditor” training. It typically lasts for 3 days.
Review of documentation
How good are the top-level procedures, work instructions, and forms? What needs to be done next?
First internal audit at the factory
The internal auditor should be able to perform a first internal audit (together with a consultant).
The internal auditor will generate a report, and follow-up actions will be listed.
First management review at the factory
Now that there is an internal audit, a management review can be done (with a consultant).
Submission of documents to the registrar
Once a registrar is chosen and the top-level documentation is ready, the application is filed and paid for, and they review it and give feedback on what to improve.
Follow-up actions can usually be carried out quickly.
Let processes gain a bit of maturity
The factory should operate under the new quality management system for about 4 weeks.
During that time, one pre-audit a week can be performed, to confirm all is good.
Official audit by the registrar at the factory
Auditor(s) are sent to the factory and evaluate whether the quality management system is effective and is compliant with ISO 9001:2015.
There are often follow-up actions to implement quickly (without threatening the certification status).
Paper certificate
It’s done. The factory is certified. The work is only starting…
Keeping the system alive
Hopefully, someone at the factory will keep improving the quality system, as well as the production and supply chain processes.
Having a big customer constantly pushing for that and running their own audits is a good motivating force…
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So here you go, this is the way we do it at Sofeast. Ideally we would work first on improving processes and layouts, reduce waste, and streamlining what is excessively convoluted, and finally implement ISO 9001 to keep it all in place. But that’s a totally different type of engagement.
Do you know of another approach that works well?
Disclaimer
We are not lawyers. What we wrote above is based only on our understanding of the regulatory requirements. QualityInspection.org does not present this information as a basis for you to make decisions, and we do not accept any liability if you do so.
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