Insider Tips for Auditing and Visiting Cosmetic Manufacturers

Overview

As a brand and product development manager, when commissioning cosmetic manufacturing, it's essential to check the management state of the manufacturer. Relying solely on subjective factors such as pleasant staff or clean appearances, which don't serve as a basis for quality, can lead to numerous setbacks in mass production.

Before proceeding with a contract with a manufacturer, it's mandatory to request an audit. Skipping this step, whether out of concern for causing offense, inconvenience, or simply neglect, is a shortcut to failure. When you decide to pay for a product, ensuring that the manufacturer's quality control methods are up to par is a reasonable demand.

However, many might not know what to look for or confirm when visiting a manufacturer. This is natural, especially for those new to the cosmetics industry or those who haven't worked in a Quality Assurance/Quality Control department. For such individuals, this post will highlight key elements to focus on when assessing the quality capabilities of a cosmetic manufacturer.

Can you trust a manufacturer with ISO22716 and CGMP certifications?

It's not incorrect to do so, but it's also not entirely accurate. Imagine important guests, like in-laws or a significant other, visiting your home. Wouldn't you clean your house thoroughly? If they were coming the next day, you would clean all day; if they were coming in an hour, you'd clean intensely for that hour. The cosmetic industry is no exception. Since ISO and CGMP audits are not unannounced, manufacturers can somewhat prepare in advance.

That said, these certifications are not easily acquired. Preparing for them involves many aspects and cannot be done overnight. Moreover, manufacturers need to undergo re-inspection every two years, maintaining certain standards for audits, which undoubtedly impacts quality improvement.

Unverified claims suggest some manufacturers might obtain these certifications through improper means. I have come across a few certified manufacturers whose poor management made me wonder how they ever passed. Thus, it's crucial to scrutinize from the client's perspective, as neglecting this can negatively impact your brand image.

Pre-Audit Checks

There are several elements you can check before conducting an audit:

1. Confirm whether the manufacturer has ISO 22716 and CGMP certifications. If not, at least check for ISO 9001 (Quality Management System Certification).

2. Examine the organizational chart. Check whether there's a dedicated quality team or if it's integrated into the lab. Labs handling multiple tasks like sample production, new product development, and quality checks can impact the quality negatively.

3. Ensure the factory you're auditing is actually producing your product. Sometimes, manufacturers with multiple factories might show you a different one than where your product is made, leading to potential issues later.

4. Understand what third-party vendors are involved in your product's journey. A manufacturer can't do everything in-house, especially for components like sub-materials and packaging. If outsourcing is necessary for aspects like formulation manufacturing, filling, or final product packaging, these vendors should also be audited.

On-Site Inspection Checklist

When visiting a site, here are critical quality aspects to check:

1. Raw Material Storage

• Temperature Control: Each raw material has a specific storage temperature. Check if these temperatures are well maintained and recorded at least once a day.
• Shelf Life: Ask to see records of how expired materials are disposed of. Well-managed facilities keep a list and dispose of materials as they reach their expiration. Some places perform regular checks for materials nearing expiration, but ensure these checks are documented and included in the manufacturer’s guidelines.

2. Sub-materials Storage

• Temperature and Humidity Control: Check if there are records for temperature and humidity control, as these are crucial for sub-materials.
• Import Inspection: Sub-materials from vendors should be checked for quality. Confirm how this process is handled, the standards used, and how defective items are temporarily stored before return or disposal.

3. Formulation Manufacturing Area

• Weighing Room: Before manufacturing, ingredients must be weighed. Verify how scales are regularly calibrated and how the measured quantities are recorded. The order of mixing ingredients is fixed, so proper labeling is vital to prevent mistakes. Additionally, records of each ingredient used are essential for tracing issues back to their source.
• Manufacturing Room: Check the tank's (kettle's) maintenance status, cleaning schedules, and records. Cleaning methods should be well-defined, and records of who cleaned and when are a basic requirement of Good Manufacturing Practice (GMP). Also, inquire about periodic tests for microbes and airborne particles. While there’s no set frequency for these tests, guidelines should be established.
• Bulk(formulation) Storage Room: Once the formulation is completed, it might move directly to the filling area or wait in a storage room until the next production schedule. If space is limited, it may be stored in the manufacturing room. Verify how the bulk is protected from contaminants and how hygiene is maintained for the storage containers.

4. Filling Area

• Filling Line: Inadequate cleaning of filling machines is a common issue. In the worst case, contaminants can mix with the bulk, and usually, it affects packaging materials. Also, check the transfer process to the packaging area. For instance, I’ve seen conveyor belts turn a white tissue black in seconds, indicating serious quality issues.
• Filling Quantity: This varies by product, but checking the filling amount is crucial. Confirm if the manufacturer has machines to measure the weight on the production line. Even if a manufacturer lacks such machines, ensure there’s a process to check filling accuracy. If the quality team checks only occasionally, this could indicate poor quality control.

5. Packaging

• Work Instructions: Each brand has different requirements and designs. Workers can only pack as they’ve been trained or instructed, so control is exercised through work instructions. These should detail packaging direction, quantity, and methods. If a manufacturer substitutes pre-work training for this, question their quality.

6. Quality Team (Lab)

• It’s necessary to check what inspections are conducted on products in production. A reputable manufacturer will randomly check products during production and conduct post-production tests, submitting reports to clients. While the specifics vary by product, request to see what items they test.

7. General

• Dress Code: In areas like the formulation manufacturing, filling, and packaging rooms, wearing work hats and clothes to prevent contamination is mandatory. The hat should cover the ears completely. Wearing gloves for fingerprint prevention and hygiene, and not wearing jewelry or accessories, is also essential.
• Standard and Limit Samples: A standard sample is the benchmark for all mass-produced items. The sample approved by you during the development process becomes this standard. Manufacturers should place these samples strategically for workers to continuously check against them for quality. If you have established limit samples, these should also be positioned appropriately.

Conclusion

Finding a manufacturer that perfectly complies with over 100 checklist items is challenging. Larger manufacturers are more likely to meet these standards, but this typically means higher costs and minimum order quantities. Therefore, ensuring the essential elements I’ve guided are met is important.

This guide will help you determine whether to collaborate with a particular manufacturer and lay the foundation for your brand's successful journey. Here's to forging productive partnerships with quality manufacturers and producing high-quality products.