CCMC plant inspection requirements

A manufacturing plant inspection for the Canadian Construction Materials Centre's (CCMC) assessment purposes supports the continued assessment of a material, product or system to meet the requirements of a standard or building code, as established by the CCMC, and protects the health and safety of Canadians. A CCMC assessment considers all properties necessary for a product to perform, including chemical, thermal, moisture, fire-resistance, durability and others. Changes in seemingly insignificant aspects of a manufacturing process can have a substantial impact on the conformance of a product.

1. General requirements

CCMC assessment-related inspections must be conducted by an inspection body that is accredited for plant inspections to the standard ISO/IEC 17020 and recognized by the International Accreditation Forum (IAF) mutual recognition agreement.

Responsibilities of the inspection body and the inspector

The inspection body is responsible for submitting and approving inspection data that is complete and accurate to the CCMC through the Plant Inspection Form. The CCMC requires that inspection forms be transmitted directly to the CCMC by the inspection body. Forms received from the manufacturer/client will not be accepted.
The inspector and/or inspection body is not responsible for resolving non-conformances, or for judging their impact or significance on product performance/conformance. The inspection body may provide suggested resolutions but this is not a requirement.
The inspector must provide a detailed description of the non-conformance on the CCMC Plant Inspection Form so that the CCMC can assess the condition and resolve the non-conformance with the manufacturer. Forms submitted to the CCMC without sufficient detail may be rejected by the CCMC.

Types of inspections

Instructions are provided for two types of plant inspections: initial and follow-up. The CCMC will specify the type of inspection to be performed.

Initial plant inspections focus on ensuring that the product that was tested for the CCMC's assessment is consistent with the documented quality system and product currently under production.
Follow-up plant inspections focus on the product's production and compliance with the documented quality system for the period following the previous inspection.

During an initial plant inspection, if it is not possible to obtain the necessary information to verify certain aspects of the inspection (for example, a formulation record for the lot or batch of the product tested for CCMC assessment purposes), a review of a random sample of records from the previous 3-year period must be conducted by the inspector. In this case, the inspector should note this information in the Plant Inspection Form.

2. CCMC requirements for each section of the Plant Inspection Form

Inspection details

When completing a CCMC plant inspection, the inspector must ensure that the inspection details section is accurate and complete.

Inspection scope

The inspector must record all products, including the respective CCMC numbers included in the scope of the inspection.

Documentation review
Item	Initial plant inspection	Follow-up plant inspection
3a.	The inspector must review the CCMC assessment and determine if the product names listed match the product names in the documented quality system. Even minor differences in product name (capitalization, symbols, etc.) must be identified.
3b.	The inspector must review all necessary documentation to determine whether all of the CCMC minimum documentation requirements have been met. If at any point during the review, a non-conformance is discovered, the inspector must identify the document and section reference on the Plant Inspection Form and move to item 3c. The CCMC will conduct a full review of the documentation. The validation of quality control tolerances is an important focus for documented quality system requirements. The CCMC requires manufacturers to be able to demonstrate that the quality control tolerances specified in their documented quality system are correlated to the compliance of the finished product (to whatever standard or CCMC technical guide forms the basis of the assessment). The CCMC does not specify how that correlation must be made, but evidence of the validation of quality control tolerances must be documented.	The inspector must review the revision and issue date of all necessary documentation from the previous inspection to determine if the documentation has not changed. All changes must be reported to the CCMC on the Plant Inspection Form. The inspector does not need to review the document's contents. The CCMC will conduct a full review of the documentation if changes are identified.
3c.	The inspector must review all product labels bearing a CCMC number relevant to this inspection and confirm that the labels comply with the CCMC requirements and the documented quality system and identify the correct CCMC assessment, including the correct product name(s).

Production review
Item	Initial plant inspection	Follow-up plant inspection
4a.	Product or process changes: The inspector must review the necessary production records to reasonably determine if there have been any changes to the product's design (colour, geometry, etc.), formulation, production process, incoming raw materials, quality control, or quality assurance parameters compared to the product sample tested for CCMC assessment purposes. The inspector may need the manufacturer to supply sampling documentation. The inspector must provide a detailed description of all observed differences. If the manufacturer cannot trace the tested batch or lot, the inspector must note this in the Plant Inspection Form and instead review a random sample of documentation over the previous 3-year period.	Product or process changes: The inspector must review the necessary documentation (typically production records, formulation sheets, design specifications, etc.) to determine if the product's design (colour, geometry, etc.), formulation (including component tolerances), production process, incoming raw materials, or quality control/quality assurance parameters have changed since the last inspection.
4b.	Production tolerances and compliance: The inspector must review the production tolerances in place for the product sample tested and verify that the production tolerances currently in operation are the same as the original assessment, or that the CCMC has been informed, in writing, of any changes. The inspector must also review at least 3 production records, randomly selected from the start of sampling until the inspection date to determine if the production tolerances are being respected. Where out-of-tolerances occur, the inspector must provide detail on the corrective action (if any) taken, including the disposition of the non-conforming product. The inspector must note if there is no documented evidence that the non-conforming product was diverted prior to leaving the plant.	Production tolerances: The inspector must review at least 3 production records, randomly selected from the period since the last inspection, to determine if the production tolerances have changed (and, if so, to determine if there is evidence that the change has been reported to the CCMC in writing), and that tolerances are being respected. Where out-of-tolerances occur, the inspector must provide detail on the corrective action (if any) taken, including disposition of the non-conforming product. The inspector must note if there is no documented evidence that the non-conforming product was diverted prior to leaving the plant.
4c.	Raw materials: The inspector must review the raw materials used in the production of the product sample tested for CCMC assessment purposes and verify that the raw material suppliers are approved by the current documented quality system, or that the CCMC has been notified, in writing, of the change in suppliers. If the raw material suppliers have changed, this must be noted in the Plant Inspection Form. Regarding raw materials, "the same" means materials that have the same Chemical Abstracts Service (CAS) Number and are sourced from the same supplier.	Raw materials: The inspector must review the raw materials currently used in production and determine if all raw materials are approved by the documented quality system. The inspector must also review 3 production records, randomly selected since the previous inspection, and determine if all raw materials used in production are approved by the documented quality system.

Quality control review
Item	Initial and follow-up plant inspections
5a. & 5b.	Raw materials quality control: The inspector must review the necessary documentation to determine if the quality control checks on incoming raw materials are being performed as required (correct checks, at the correct frequency) by the documented quality system. The manufacturer must be able to produce a log of all quality control results, including any non-conforming products and the resulting corrective actions. The inspector must review sufficient documentation to support that non-conforming products are being corrected or diverted as reasonably appropriate, or as required by the documented quality system. If the inspector is not able to find records of any non-conforming products since the previous inspection, this must be noted in the Plant Inspection Form.
5c. & 5d.	Production quality control: The inspector must review the documentation to determine if the quality control checks during production are being performed as required (correct checks, at the correct frequency) by the documented quality system. The manufacturer must be able to produce a log of all quality control results, including any non-conforming products and the resulting corrective actions. The inspector must review sufficient documentation to support that non-conforming products are being corrected or diverted as reasonably appropriate, or as required by the documented quality system. If the inspector is not able to find records of any non-conforming products since the previous inspection, this must be noted in the Plant Inspection Form.
5e. & 5f.	Measurement equipment: The inspector must review all equipment used in making measurements related to quality control or quality assurance parameters. All staff involved in quality control or quality assurance measurements must also have documented records of competence.

3. Non-conformance criteria

For each plant inspection, inspection bodies are asked to provide a result of one of the following:

no findings
minor non-conformance
major non-conformance

The inspector must provide sufficient detail describing any non-conformances found during the inspection such that the CCMC can determine the potential technical impact of the non-conformance based on the description. The inspection body must provide an inspection result; however, the CCMC will review the information provided and may increase or decrease the severity of the inspection result based on its own judgment.

The following is provided to assist inspectors in determining inspection results:

Minor non-conformances

In general, the CCMC considers any non-conformance that is related to documentation, recordkeeping, or compliance with general documented quality system requirements to be minor, provided it does not impact the compliance of the product with the assessment criteria (for example, a standard or a CCMC technical guide).

Examples of minor non-conformances include the following:

non-compliance with the CCMC minimum documentation requirements (this may be considered a major non-conformance if it is clear that the deficiency may impact product compliance)
an out-of-date or missing calibration record for a piece of measurement equipment
typographical errors or changes to the documented quality system (this is considered a major non-conformance if the errors have a technical impact)
missing or incorrect competence records for staff
missing validation of quality control or quality assurance parameters
incorrect references to the CCMC numbers or product names in documentation or on product labels (this is considered a major non-conformance if products are being labelled with CCMC numbers that have not been evaluated by the CCMC)
missing or incorrect production records (this may be considered a major non-conformance if the error may impact product compliance)

Major non-conformances

In general, the CCMC considers any non-conformance to be major that may impact the compliance of the product with the assessment criteria (for example, a standard or a CCMC technical guide).

Examples of major non-conformance issues include the following:

any change in raw materials (either Chemical Abstracts Service (CAS) Registry Number or supplier)
any change in product formulation or formulation tolerances
any change in quality control or quality assurance parameters or tolerances
any change in production equipment
any product labelled with a CCMC number that has not been evaluated by the CCMC

4. Resolving non-conformances

General

When non-conformances are brought to the attention of the CCMC by an inspection body through submission of a Plant Inspection Form, the CCMC reviews the information provided by the inspection body and takes action, depending on the non-conformance criteria.

Plant inspection cycles are not adjusted for non-conformance resolution. Where the time required to resolve a non-conformance exceeds a single inspection period, the unresolved non-conformance(s) should be identified during the subsequent inspection.

Where the CCMC, in its discretion, determines that a non-conformance is significant enough to require the involvement of its evaluation staff (typically for major non-conformances, but may also be applicable to some minor non-conformances) a $2,500 CAD non-conformance fee will be issued to the client. This is to offset the effort required by the CCMC to manage and review the resolution of the non-conformance by the client.

Minor non-conformances

The CCMC will contact the client and provide the requirements for resolving the non-conformance. The client may propose alternate means of resolution, which will be reviewed and may be accepted by the CCMC with sufficient justification.

Minor non-conformances for cause must be resolved within 60 days of notification, unless otherwise permitted by the CCMC, such as for required testing or other actions that would not reasonably be achievable within this timeframe.

When deemed necessary, the CCMC may require verification of non-conformance resolution at the next plant inspection. The CCMC will inform the inspection body prior to the next inspection date.

Failure to resolve minor non-conformances as required by the CCMC may result in one or more of the following:

temporary suspension of the CCMC assessment(s)
removal of the plant location(s) from the CCMC assessment(s)
a full re-assessment by the CCMC (which may include partial or full re-testing)

Major non-conformances

Generally, major non-conformances for cause must be resolved within 30 days of notification, unless otherwise permitted by the CCMC, such as for required testing or other actions that would not reasonably be achievable within this timeframe.

For major non-conformances with significant impact (for example, health and safety, or the reputation of the CCMC), the CCMC may require resolution within a much shorter timeline or may immediately suspend or withdraw the assessment. In severe cases, the CCMC may require the recall of the non-conforming (or suspected non-conforming) product marked with a CCMC number.