On this page
- 1. General requirements
- 2. CCMC requirements for each section of the Plant Inspection Form
- 3. Non-conformance criteria
- 4. Resolving non-conformances
A Canadian Construction Materials Centre (CCMC) manufacturing plant inspection supports the continued assessment of a construction material, product or system. Plant inspections monitor the manufacturing process to ensure that product continue to meet the requirements of the National Model Codes and related standards or technical guides used to evaluate it, and to help protect the health and safety of Canadians.
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 Standards Council of Canada and/or the International Accreditation Forum (IAF).
Responsibilities of the inspection body
- Ensures inspectors are familiar with the CCMC plant inspection requirements and plant inspection form.
- Submits the plant inspection form to the CCMC. Forms received from the manufacturer or client will not be accepted.
- Reviews inspection data and ensures it's complete and accurate.
- Ensures that all the CCMC assessment numbers and the products associated with each CCMC number are included in the scope of the plant inspection.
- Clearly identify areas of non-conformance to the manufacturers quality system and/or CCMC minimum document requirements. The inspector and/or inspection body is not responsible for resolving non-conformances, or for judging their impact or significance on product performance/conformance.
- In such cases, the inspection body must ensure that the inspector 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.
- Retains inspection records to ensure consistency between follow-up inspections throughout the manufacturing plant's participation in the CCMC monitoring program.
Types of inspections
Instructions are provided for 2 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.
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 in the plant inspection form.
Inspection scope
The inspector must record all CCMC numbers and ensure all products covered by this number are included in the scope of the inspection.
The inspection scope will also include a review of the products records of last production, even if they are not in production at the time of inspection.
Initial plant inspection
Documentation review
3a.
The inspector must review the CCMC assessment if one already exists and determine if the product name(s) listed match the product names in the documented quality system. Even minor differences in product name (capitalization, symbols, etc.) must be identified. If the initial plant inspection is related to a new listing, the product name(s) will be provided by the CCMC.
3b.
The inspector must review all necessary documentation to determine whether all of the CCMC minimum documentation requirements have been met. In the plant inspection form, the inspector will identify where each of the required CCMC sections is located in the documented quality system. If at any point during the review, a non-conformance is discovered, the inspector must identify the document and section reference in the plant inspection form and move to the product labelling section (item 3c). The CCMC will conduct a full review of the documentation.
Validating quality control tolerances is an important part of the 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.
3c.
The inspector must review all product labels with a CCMC number relevant to the inspection. They must also confirm that the labels comply with the CCMC requirements, which include the use of the CCMC mark along with the CCMC evaluation number and the documented quality system, and identify the correct CCMC assessment, including the correct product name(s).
Production review
4a.
Validation of the sampled product:
The inspector must review the product sampling report relevant to the product(s) being inspected to identify which production records to review. This will help determine if the samples are representative of the documented production processes including any changes to the product's design (colour, geometry, etc.), formulation, production process, incoming raw materials, quality control or quality assurance parameters.
If the manufacturer cannot trace the tested batch or lot, the inspector must note this in the plant inspection form and instead review the production records from a minimum of 3 separate time periods (from the date of sampling to the most recent production). The inspector will provide the production dates that were reviewed and include them in the plant inspection form.
4b.
Product or process changes:
The inspector must review the product sampling report relevant to the product(s) being inspected along with 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 must provide a detailed description of all observed differences.
4c.
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 production records indicate that the product did not meet production specifications, the inspector must provide detail on the corrective action taken (if any), including the disposition of the non-conforming product. The inspector must note instances where there is no documented evidence that the non-conforming product was diverted prior to leaving the plant.
4d.
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 term "the same" means materials that have the same Chemical Abstracts Service (CAS) number and are sourced from the same supplier.
Quality control review
5a. and 5b.
Quality control of raw materials:
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 and 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. and 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 and 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. and 5f.
Measurement equipment:
The inspector must review all equipment used in 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.
Follow-up plant inspection
Documentation review
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. The inspector will identify in the inspection form where each of the required CCMC sections is located in the documented quality system and compare this to the previous inspection. 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. The CCMC will conduct a full review of the documentation.
Validating quality control tolerances is an important part of the 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.
3c.
The inspector must review all product labels related to the CCMC evaluated product and confirm that the labels comply with the CCMC requirements and the documented quality system. The inspector must also identify the correct CCMC assessment, including the correct product name(s).
Production review
4a.
Confirmation of production:
The inspector will review production records for all CCMC evaluated products to confirm the plant has completed at least 1 production cycle of each product within the last year (since the last inspection). The inspector will identify any product(s) that were not produced and the last date of production.
Note: there is no requirement for the size of the production run. The CCMC requires that each plant completes at least 1 production run but does not require a specific volume. Small batches to demonstrate quality control are deemed acceptable.
4b.
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.
The inspection will also confirm whether the plant has completed at least 1 production run for each product within the last year.
4c.
Production tolerances:
The inspector must review at least 3 production records, randomly selected from the period since the last inspection, to determine whether the production tolerances have changed. If there have been changes in the production tolerances, the inspector must determine if the change has been reported to the CCMC in writing, and that tolerances are being respected.
Where production records indicate that the product did not meet production specifications, the inspector must provide details on the corrective action taken (if any), including disposition of the non-conforming product. If there is no documented evidence that the non-conforming product was diverted, the inspector must note this prior to leaving the plant.
4d.
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
5a. and 5b.
Raw materials quality control:
The inspector must review the necessary documentation to determine whether the quality control checks on incoming raw materials are being performed as required (correct checks and 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. and 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 and 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. and 5f.
Measurement equipment:
The inspector must review all equipment used in 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 must provide a result of one of the following:
- no findings
- non-conformance
The inspector must provide sufficient detail describing any non-conformances found during the inspection so that the CCMC can determine the potential technical impact of the non-conformance. The inspection body must provide an inspection result; the CCMC will review the information provided and will inform the evaluation holder of next steps.
The following examples of non-conformances are provided to assist inspectors in determining inspection results:
- 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
- CCMC numbers that have not been evaluated by the CCMC
- any product labelled with a CCMC number that has not been evaluated by the CCMC
- non-compliance with the CCMC minimum documentation requirements
- an out-of-date or missing calibration record for a piece of measurement equipment
- typographical errors or changes to the documented quality system
- missing or incorrect competence records for staff
- missing validation (records) of quality control or quality assurance parameters
- incorrect references to the CCMC numbers or product names in documentation or on product labels
- missing or incorrect production records
- company name and/or product names that do not match the published CCMC report
4. Resolving non-conformances
General
The CCMC requires corrective actions to resolve any non-conformance(s) identified in the plant inspection form.
When a non-conformance requires the time of a CCMC evaluation officer, a non-conformance fee of $2,500 CAD will apply. This is to offset the effort required by the CCMC to manage and review the resolution of the non-conformance.
Non-conformance resolution
The CCMC will contact the evaluation holder and provide the requirements for resolving the non-conformance. The evaluation holder may propose alternate means of resolution, which will be reviewed and may be accepted by the CCMC with sufficient justification.
For non-conformances with significant impact, 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.
Non-conformances must be resolved within the timeframe indicated by the CCMC. The CCMC will define the actions and records required to confirm that the non-conformance has been resolved; this may include repeated inspections in addition to the regular inspection cycle.
Failure to resolve 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
- withdrawal of the CCMC assessment