Is a MOC carried out before any new product/activity is carried out to ensure the site is fully capable? Are all relevant areas involved? Is there a formal process and is it documented? How are evaluations carried out and who is involved? Do they use the checklist provided in App 3? If not, does the local process include all the aspects from Appendix 3? How is this recorded? Review examples - new products, new RM's, changes in production processes.