"I am working as QMS M.R., facing difficulties in design and development clause as it was not in my previous working organization. Need help in the same for developing records, conducting reviews and risk analysis. additionally, will you be able to provide new work instruction formats content (points to be mentioned in WI format).”
I like to see design and development as a journey.
At the beginning of that journey, your organization at step 1 collects all the requirements that a new product or service must comply with. These requirements can be performance specifications; compliance specifications; timing specifications; production or provision constraints, …
During step 3 your organization creates the product or service prototype, or the first samples. With that prototype or samples, a verification is made by comparing actual performance with all the constraints and performance established as inputs at step 4.
At step 5 the product or service is tested by the customer to val idate its performance in real life conditions.
Remember that in the end, your organization should have:
Product or service specifications;
Production process or service provision specifications and instructions;
Purchasing specifications; and
Documented information specifications.